Therapeutic Resume Samples

The Guide To Resume Tailoring

Guide the recruiter to the conclusion that you are the best candidate for the therapeutic job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

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Q Fahey

Queen

Fahey

7183 Ward Stravenue

Los Angeles

+1 (555) 911 4901

7183 Ward Stravenue

Los Angeles

Phone

p +1 (555) 911 4901

Experience Experience

Philadelphia, PA

Therapeutic

Philadelphia, PA

Senger-Stanton

Philadelphia, PA

Therapeutic

Work with BPMs to facilitate annual processes for developing medical strategies, operational plans and budgets for the TA
DRIVING AND DEVELOPING A TEAM OF MEDICAL AFFAIRS MANAGER AND MSLin consistency with the objectives and company policies
Collaborate with Legal, Compliance and Regulatory to establish and ensure proper and ethical conduct of TA GMA personnel across all activities
Works independently and leads team
Leading cross-functional projects in order to improve company processes
Providing input to strategic product placement from a safety perspective
Developing and guiding presentations to the Executive Safety Review Committee

Phoenix, AZ

Global Therapeutic

Phoenix, AZ

Sipes Inc

Phoenix, AZ

Global Therapeutic

Manages and develops 1 direct and 1 indirect report (both based in EMEA)
Develops and implements global, multi-site, multi-culture workforce communications strategy and messages that inspire, engage, inform and align employees
Executes integrated stakeholder activation strategies, deal communication and partner management
Fosters and reinforces an authentic commitment to Our Credo; informs and shapes belief in our leadership imperatives to strengthen collaboration and teamwork
Develops and guides implementation of executive leadership and engagement strategy, positioning senior leaders with key stakeholders
Develops strong relationships and acts as trusted advisor to ID Therapeutics R&D Head, GCSO Leader, other SLT members and key scientific leaders
Personally leads and executes the strategic positioning and all aspects of communication for global ID Therapeutics R&D

present

Philadelphia, PA

Therapeutic Consultant

Philadelphia, PA

Wiza, Kohler and Leuschke

present

Philadelphia, PA

Therapeutic Consultant

present

Recognizes staff with Pro team, performance management evaluations, individual development goals, etc
Manages budgeted staff hours to provide effective and efficient service delivery
Develops and implements service plan within 30 days of moving in, annually, when significant changes occur, and when moving out
Ensure assigned staff is evaluated fairly and timely in accordance with ResCare performance evaluation procedures
Develops waiting list for potential consumer vacancies
Actively works toward achieving/maintaining Affirmative Action goals within assigned service site(s)
Ensures consumer and guardian participation in development of service plan and personal futures plan

Education Education

Bachelor’s Degree in Life Sciences

Belmont University

Bachelor’s Degree in Life Sciences

Skills Skills

Good knowledge of computer based programs including spreadsheets and graphics
Confident discussing scientific/mechanistic aspects of drug development, also comfortable in discussing commercial and regulatory issues
Comprehensive industry knowledge
Good in English
Strong understanding of the elements of drug development programs
Demonstrated ability to present data, plans and strategies clearly and accurately to relevant audiences in order to obtain decisions
Strong sales track record
Ability to read, analyze and interpret scientific and technical journals
Working knowledge of MedDRA coding and experience in developing case series retrieval strategies
Able to independently formulate development or lifecycle strategy

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Therapeutic Manager Resume Examples & Samples

PharmD or PhD in a pharmaceutical science preferred
2+ years of drug information or related clinical pharmaceutical experience
Flexibility to travel as required

Clinical Therapeutic Resume Examples & Samples

Optimization of the TA portfolio including prioritization and decision making
Ensures Operational excellence in all aspects of clinical support,
Effective review and interpretation of clinical study results through engagement with program leaders; captures thinking in concise and clear written reports
Shapes strategic and operational direction of the TA portfolio to align with short terms goals and medium and long term strategy, and ensures a culture of innovation in clinical development
Supports the use of drug devices, and works internally and with partners to establish companion diagnostics
Partners effectively with Research & Non-Clinical Development, HEOR, Medical Affairs and Commercial to move forward the R&D pipeline and maximize value
Contributes to thinking related to clinical protocol development, safety data review, labeling and product plans
Is outward looking and familiar with competitor activities in areas of focus, and establishes opportunities for product differentiation
Evaluate and be responsible for R&D budget across the TA
MD degree with board certification or equivalent in a medical specialty
A seasoned R&D leader with 10+ years of drug development experience, early through late stage development, including the design and conduct of Phase 1-4 clinical studies. Experience with multiple therapeutic modalities, principally small molecules and biologics, would be preferred
Experience in the due-diligence/in-licensing arena
Credibility within the international medical and scientific community. Demonstrated links and strong industry contacts with thought leaders/centers in the Neuroscience therapy area
Excellent interpersonal and communication skills. Ability to act as company spokesperson or scientific witness as needed
International experience is preferable
Experience with drug devices and companion diagnostics would be preferable

Clinical Programs Therapeutic Areas Head Resume Examples & Samples

Provides leadership, review of and input to the design of clinical development programs to meet commercial, regulatory and all US & Global scientific objectives for the assigned programs
Strategic leadership of Clinical Programs: Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. Manages a changing number of Clinical Research Operations professionals, who many supervise other employees within Clinical Operations. Responsible for talent development, career management and succession planning. Manages resource needs and if necessary builds business cases to support outsourcing strategy or FTE changes
Establishes and maintains close partnerships w/Statistics, Medical Writing, Clinical Data Management, Clinical Trial Support, Clinical Quality Assurance and R&D Compliance to optimize Clinical Programs performance and delivery in meeting objectives. Provides Clinical Programs input to the Clinical Development Operations Leadership Team. Participate in Shire internal governance meetings as necessary, e.g. Compliance Forum or SOP Review Committee. Serves as point of contact for and is responsible for responding to Quality Assurance Process Audits
Ensures operations teams remain on schedule and within budget for assigned clinical programs. Drive strategic thinking and mitigation strategies across programs. Reviews budgets, forecasts, and accruals for all projects
Develops and reviews strategy for operational efficiency; involved in SOP development through SRC and identifying SMEs and promotes standardized use of Clinical R&D business tools
Bachelor’s degree in a scientific discipline required. Master’s degree and/or PhD in the medical or life sciences is preferred
Significant experience (14+ years) of clinical research and group leadership experience within the pharmaceutical industry, a CRO or similar organization is required
Global experience is preferred
Previous line management of at least 10 years is required
Experience of regulatory submissions is required

Therapeutic Resume Examples & Samples

Managerial oversight of a group of team product safety physicians in DSS
Driving content of and supervising, mentoring and training the writing of Sections 6 and 9 for all PSURs and ad hoc regulatory queries
Driving the strategy for and supervising, mentoring and training the writing of risk management plans for both internal use and regulatory submission
Mentoring and training the implementation and execution of Safety Review Team practices, including integrated risk management and assessment activities throughout the product lifecycle
Understanding the implications of the evolving US and global risk management guidances and legislation and translating to the Shire environment in order to evolve practices to meet regulatory expectations
Personally assuming and overseeing work carried out on products and/or issues under highest scrutiny from patient protection and regulatory perspectives
Developing and guiding presentations to the Executive Safety Review Committee
Providing required support to the EU Qualified Person for Pharmacovigilance
As part of the Drug Safety Surveillance Leadership team influence the strategy for Shire Global Drug Safety Organization
Act as senior leaders in Global Drug Safety ensuring excellent collaboration and networking within and outside of R&D
Providing input to strategic product placement from a safety perspective
Medical Degree required
Post-graduate training and regional certification in a subspecialty preferred
At least 10-12 years of pharmaceutical industry experience, the majority in traditional and global pharmacovigilance departments, with at least 4 years of experience managing, mentoring and training other safety physicians. Prior positions in clinical research and/or medical affairs departments preferred
Must have extensive current experience (preferably related to multiple products and therapeutic areas) in personally writing PSUR medical assessments, ad hoc safety query responses, and submissable risk management plans and in supervising, mentoring, training other safety physicians in this work
Must have experience in implementing and running Safety Review Team type forums, with experience in implementing and mentoring a full range of integrated risk management and assessment activities throughout the product lifecycle
Must understand the implications of the evolving global risk management guidance’s and legislation and be able to translate to the Shire environment in order to evolve practices to meet regulatory expectations

Therapeutic Resume Examples & Samples

Responsible for the strategy and implementation of benefit-risk management for Shire products. Development of REMS, DRMP’s & RMP’s, regulatory responses for risk management topics and other product position statements as assigned for submission to regulatory agencies
Actively participates in Benefit- Risk Committees and other safety committees as needed. Effectively manages the Benefit/Risk process
In support to the Head of Risk Management, supervises assigned team of Risk Management specialists for various therapeutic areas and/or products. Supervision and support includes but not limited to
MD, PhD or Pharm D with specialty training in functional area at least 10 plus years of experience in pharmaceutical industry within Drug Safety / Pharmacovigilance with both investigational and marketed products
At least 5 years of experience writing and preparing risk management documents, including Risk Management Plans, Pharmacovigilance Plans and Risk Minimization Plans or REMS for submission to regulatory agencies
Previous experience in bioscience preferred
Product defense before a national or international regulatory authority a plus
Ability to read and analyze scientific and medical literature
Ability to work with interdisciplinary, highly matrixed team
Knowledge and active use of Microsoft Word, Excel, Powerpoint, Outlook, and Adobe Acrobat
Analytical and problem solving skills
Oral and written communication and interpersonal skills
Planning and Organizing
Ability to manage multiple projects simultaneously while remaining responsive to strict deadlines
Ability to establish and maintain professional communication both internally and externally with all stakeholders

Therapeutic Resume Examples & Samples

A Physician (MD or equivalent), is required. A Board Certification (if US) is preferred
10 or more years of Pharmaceutical Industry experience including 5 years of either pharmacovigilance experience or clinical development research is required
Significant skills in clinical medicine and pharmacovigilance, including experience in post-marketing safety assessment are desired
Experience with oncology is not a requirement to do this job successfully but, it would be a plus
Demonstrated in-depth knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and safety assessment of drugs both on the market and in development are highly desired
Proven track record in dealing with difficult safety issues, clinical safety data, interactions with domestic and /or international regulatory departments / agencies, and strong collaborative and networking skills is required
Experience with domestic and international regulatory departments / agencies are highly preferred
The ability to successfully manage multiple critical issues simultaneously, critically evaluate data from multiple sources (e.g., clinical trials, post-marketing environment, literature), and assess the strategic importance of the data is required
Knowledge of Good Clinical Practices and PV regulatory requirements, the conduct of clinical trials and for the appropriate contributions to regulatory filings, PV documents and risk management plans are all highly desirable
Management experience in supervising a group of employees is preferred
The ability to develop, implement, communicate and influence policy and strategy internally and externally to the company is desired
Formal presentation skills are required
Experience presenting to technical and lay groups at public meetings is desirable
Written skills as evidenced by publication and journal articles is desirable

Therapeutic Resume Examples & Samples

DEVELOPING THE LOCAL MEDICAL STRATEGY for the Oncology Therapeutic Area in alignment with the Global Strategy
LEADING MEDICAL AND SCIENTIFIC LITERATURE AND KNOWLEDGEto the solid tumors area, ensuring compliance with SOP and company policies, and adherence to applicable regulations. This activity includes
Designing the registrative dossier produced for regulatory and HEMAR (Health Economics, Market Access and Reimbursement) purposes, using the medical/scientific knowledge as well as that in external fields in order to develop project-based and conceptual activities
Leading cross-functional projects in order to improve company processes
Leading the definition of an integrated evidence generation plan with key focus on Evidence Gap assessment and research questions in collaboration with the Country Value Team and driving the Medical Affairs generation plan developing ideas into projects to produce real world evidence that will support Company strategies needs
PLANNING AND LEADING THE CLINICAL RESEARCHACTIVITIES,interventional/non-interventional, local and international activities related to the clinic of the therapeutic area of expertise, ensuring compliance with ICH – GCP, SOP and company policies and adherence to applicable regulations and the deadlines and costs planned
BUILDING STRONG RELATIONSHIP WITH KEY PUBLIC AND ISTITUTIONAL STAKEHOLDERSin order to became the point of contact for them and build up a strong credibility in the Oncology Area
DRIVING AND DEVELOPING A TEAM OF MEDICAL AFFAIRS MANAGER AND MSLin consistency with the objectives and company policies
MANAGING THE BUDGETof projects in the Oncology therapeutic Area
NETWORKING WITH THE INTERNATIONAL MEDICAL AFFAIRS TEAMto develop a Global strategy but also to influence strategic decision and attract investment for Italy. This activity includes
Medicine degree/ A Specialization in Oncology is a mandatory requirement (preferably a deep knowledge of Lung cancer)
Previous experience as Therapeutic Area Medical Manager in Oncology
Strong clinical practice experience
Strong experience in the Pharmaceutical Clinical Development (mainly in the uro – oncology area and in the lung cancer)
In – depth knowledge of study methodology, study data and analysis
Excellence knowledge of study publication processes and publications within the relevant Oncology Therapeutic Area
Consolidated experience as People Manager
A demonstrated strong Leadership and ability to impact important decisions
Previous experience as Responsible of one or more Therapeutic Area
Fluent in English and in Italian

Regional Therapeutic Resume Examples & Samples

Collaborate with the study placement group and the local organizations to validate/update epidemiologic data gathered centrally
Collaborate with the Global Enrolment Strategy (GES) group and local organizations to validate/update regional TA expertise/intelligence database (country categorization, top recruiters,…)
Have a good in depth understanding of the pathology and knowledge of the development programs (strategy, positioning of the product, competitive environment,…)
Engage directly peer to peer contacts to build and maintain strong partnerships with investigators, KoLs, investigational sites, local experts, academic groups in the different countries of the region
Have a good understanding of the standard of care in the region, the different health care systems and be able to assess potential impact on TA programs, reference drugs and advise central teams and TA on the future strategy for the region
Provide central teams (GPL) and TA with consolidated input from the regions on protocol proposals/outlines (protocol feasibility) and identify factors for successful recruitment and country selection (scenario building)
Provide regional/country input in the feasibility questionnaire to the GTM before finalizing the feasibility questionnaire to ensure optimal country and site selection for successful trial execution (start up, recruitment and quality)
Work with the GTL to define a consolidated proposal of country and site selection balancing maximizing on the true potential of a country, recruitment potential and speed and quality. Define back up strategy
Will be held accountable for all agreed qualitative/quantitative metrics for the region in agreement with global stakeholders
Strong preference for MD/PhD (minimal Master degree with specific specialization is required)
6 years of experience with clinical research and proven experience with the TA within the region. Solid knowledge of ICH-GCP, GCO SOPs and relevant local regulations related to clinical research, and understands what drives clinical operations performance
Experience of successfully working a heavily matrixed organization. Able to lead and influence without direct authority. Exceptional networker, who easily connects across the organization and across countries. You are effective in working in a virtual global organization
Excellent overall business acumen and strong analytical skills. Able to sets priorities across a multitude of opportunities based on business analysis and customer research, and to craft a structured approach to drive execution. Understands the importance of solid process design
Internal and external partnering; ability to build relationships across the business and externally; ability to influence clinical research strategies to ensure successful execution of current and future clinical trials
Good clinical research and medical expertise enabling peer-to-peer connections with KOLs. Capable of providing TA, compound and protocol training within the region as necessary (lead local Investigator meetings if needed)
Comfortable with ambiguity. Deals well with shaping direction in a new area, and building a new organization with limited guidance. Challenges status quo. Understands and where needed adapts to different cultures and markets
Advanced communication and presentation skills required
Pro-active mindset and attitude
Proficiency in writing and speaking of English; multilingual skills is an advantage
Willingness to travel (25% of your time)

Medical Therapeutic Resume Examples & Samples

Propose new scientific/medical development ideas in line with brand and innovation strategy
Lead and develop Health Care Provider strategy in alignment with brand team with or without agencies
Ensure scientific and competitor intelligence and advise the marketing teams on product positioning. Give medical input for the briefing of clinical studies and lead the communication of the results
Provide scientific input in claim generation and lead medical claim validation for the products in the therapeutic area
Develop Health Care Provider mapping, organize and lead scientific/medical expert meetings in line with medical and legal governance, business needs and business benefit
Develop and maintain alliances with opinion leaders and international experts, organize and lead Galderma’s sponsored medical events
Perform internal scientific medical training
Be a key member of the steering committee of the category
Coordinate cross-functional alignment with local Medical Affairs, clinical development & vigilance

Senior Therapeutic Specialist Resume Examples & Samples

Provides timely, accurate, thorough and balanced responses to unsolicited requests for information from internal and external customers consistent with regulatory guidelines. Documents interactions in Department database
Identifies captures and processes adverse events and product quality complaints following Department procedures
Conducts literature analysis to respond to unsolicited, off-label inquiries as needed
Partners with Medical Information colleagues to create and update standard clinical replies
Exchanges customer insights and scientific information with internal partners as appropriate
Attend professional meetings for Medical Information Booth support
BA/BS degree or equivalent in the clinical or healthcare field required; PharmD highly preferred
At least one year post-graduate experience in the healthcare, pharmaceutical, pharmacy retail, hospital and/or managed care environments is strongly preferred
Experience in a customer-facing role highly preferred
Strong written, oral and presentation skills required
Strong computer skills – Microsoft Office Suite required
Ability to build on existing clinical foundation in pursuit of expertise in relevant therapeutic area
Manage complexity and able to work independently
Ability to partner with cross-functional teams
Ability to mentor new employees (both J&J & contract employees)
Occasional overnight travel to attend Medical Conferences or Company Meetings required.Medical Affairs

Therapeutic Recreational Assistant Resume Examples & Samples

Assist with resident activities, assessments, and activities profiles
Assist in scheduling movies, planning parties, and providing games/activities for residents
Encourage residents to participate in recreational social activities so that all residents are involved in activities by engaging in and organizing games, crafts, religious services, parties, etc
Act in compliance with all corporate, state, federal, and other regulatory standards
Accompany residents, as needed, to activities outside the facility
Maintain an adequate inventory of supplies. Submit request for additional supplies/material in accordance with established policies
Attend meetings and inservice sessions, as directed
Assist Director of Therapeutic Recreational Services in expanding services
Embrace the Consulate Health Care's five core values of compassion, honesty, integrity, respect, and passion, and incorporate them into daily job function
Demonstrate respect and compassion in every interaction
Conduct oneself with the highest degree of honesty and integrity in every interaction
Demonstrate a passion for caring as evidenced by interactions with co-workers, residents, families, and visitors
May be trained and assigned to perform the Customer Care Liaison duties as needed
Perform other duties, as assigned
Some experience preferred in providing recreation services to residents in a health care setting

Therapeutic Recreation Guide Resume Examples & Samples

Assesses and documents resident's medical, mental and emotional needs at admission and on an on-going basis. Develops and implements a plan of care to meet resident and family needs, to include discharge planning and utilization of available resources
Acts as resident advocate; treats residents and families with compassion and implements plan of care in a safe and timely manner
Demonstrates clinical reasoning, coupled with clinical skills to conduct accurate clinical assessments and perform resident care activities; evaluates effectiveness of therapy interventions, identifies and prioritizes resident/family strengths, needs and priorities
Identifies the normal course of illness in assigned resident population recognizing and intervening appropriately when deviations occur
Communicates resident information and thoroughly documents therapist's actions and plan of care
Provides clinical leadership and mentoring to residents and team members

Laboratory Technician Iv-therapeutic Discovery Resume Examples & Samples

The Contractor will assist in the development; execution; and evaluation of high-throughput screening projects for the antibacterial; anti-viral; and anti-toxin therapeutic areas and assist in the development of novel assays/methods for various programs. This includes basic cell culture to support these efforts. Workload is approximately 50 plates per month. Will assist in screening of molecular compound libraries for therapeutic efficacy to support MCM development. May perform screenings of 10-15 libraries per year
The Contractor will support approximately 2 mouse studies per month. Will assist with inoculations of animals; collecting specimens for processing; and analysis of those specimens. Analysis may include immunological procedures including Enzyme Linked immunoassay (ELISA); Western blot; and Mesoscale Discovery based assays
The Contractor will perform basic molecular biology techniques to support creation of novel cell or enzymatic based assays for evaluation of MCM
The Contractor will assist in the preparation of technical reports; standard operating procedures; and manuscripts relating to their research efforts. The contractor is expected to present research findings at one scientific conference per year. Contractor will present results in written and oral format publicly and internally
The Contractor will be responsible for assessing and maintaining laboratory supplies in BSL-2; BSL-3 and BSL-4 laboratories. Will assess supplies and ensure supply orders are coordinated with Division resources. Will ensure that all assigned laboratory space is orderly and compliant with all regulatory guidance
Experience and skill with a large variety of the field's concepts; practices; and procedures is desired ? Must be eligible for enrollment in the Army Biological Personnel Reliability Program (BPRP)

Therapeutic Resume Examples & Samples

Determines the most effective approach to meet disease state and product-learning needs of the MSL/MCL in specific therapeutic area business. Applies instructional design principles and adult learning principles to enhance content delivery
Establishes goals and learning objectives for MSL/MCL trainings to design appropriate and effective curriculum by leveraging adult learning principles
Researches the clinical issues and leverages resources (internal and external) to support the learning objectives in designing and creating training programs and products, partnering with SMEs
Develops therapeutic area training programs as identified from MSL, MCL teams focusing on strategies and tactics that will ensure significant impact on increasing the quality of communication delivery and customer interactions
Participates as an active member on the Therapeutic Area Field teams
Facilitates training programs that will enhance the effectiveness of the Medical Affairs Field organization competencies
Participates in L&D (Learning and Development) internal training initiatives
Liaison with MSL Effectiveness
Create assessments that measure knowledge and application of content
Identify MSL/MCL medical training and professional development needs and develop and implement Global Medical Training curriculum
Collaborate with GMA teams and Compliance business partners to define medical and professional development needs of field medical personnel
Collaborate with Director and manage implementation of training solutions (both distance- and live trainings) leveraging common and custom platforms as required
Coordinate with GMA teams to generate training content
Coordinate with GMA teams to collaborate with KOLs and investigators in curriculum development as appropriate
Directly lead key training events
Partner/Monitor and ensure completion of training at predefined levels according to job function with highly coordinated communication with line managers
Filters and distributes educational resources (i.e. clinical papers) to the L&D customers and other appropriate audiences while remaining contentious of legal and regulatory parameters
30%

Rn-therapeutic Apheresis Resume Examples & Samples

Learning how to perform apheresis procedures such as therapeutic plasma exchange, extracorporeal photopheresis, and stem cell collections
Taking care of adult and pediatric patients, with many different types of diseases including cancer patients, bone marrow and organ transplant patients, patients with autoimmune diseases, and neurologic disorders
Involvement in research and participation in national organizations/meetings
Positively impacting patients, their health and quality of life
Brand new facilities in March 2017

Global Hematology Therapeutic Resume Examples & Samples

Actively participates in advancing and communicating corporate and GMA philosophy and agenda. Participates as a member of TA Management. Coordinates induction, mentoring, training, and development of team. Identifies training needs. May supervise 2-10 employees, including other MDs or PhDs. Responsible for all aspects of talent management for own team and provides feedback as part of TA management. May assist in developing/mentoring junior medical affairs staff
Participates in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and adhoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies
Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE’s & SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities
All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams. Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities
Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects
May act as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities
Oversees scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource. May develop scientifically accurate marketing materials, medical education programs, advisories, and symposia. Maintains an up-to-date analysis of competitor product information
Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc. May act as medical/scientific leader for several programs within an area. May represent the medical function on cross-functional integrated teams for medical affairs activities
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions
Drives Medical Affairs strategies and is a key internal contact/subject matter expert. May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function. Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities

AD, Therapeutic Resume Examples & Samples

Prior experience in scientific communications (publications, congress management or medical communications) including development of cross-functional strategies/plans
Prior experience with health/scientific communication principles including the use of digital media
A strategic partner with a unique understanding of the interplay between Worldwide Medical and other departments, including, Commercial, Compliance, Legal, Regulatory
Ability to develop collaborative relationships with internal colleagues
Ability to be independent, multi-tasked and results-oriented with a hands-on attitude in a fast-paced and energetic environment
Excellent written and oral communication skills
Strong team leadership and management skills

Assoc Director, Therapeutic Resume Examples & Samples

Ability to integrate product specific strategies and plans into one comprehensive plan
Prior experience in scientific communications (publications, congress management or medical communications) including development of cross-functional strategies/plans
Prior experience with health/scientific communication principles including the use of digital media
A strategic partner with a unique understanding of the interplay between Worldwide Medical and other departments, including, Commercial, Compliance, Legal, Regulatory
Ability to develop collaborative relationships with internal colleagues including senior leadership
Ability to be independent, multi-tasked and results-oriented with a hands-on attitude in a fast-paced and energetic environment
Entrepreneurial and innovative behaviors and attiude
Excellent written and oral communication skills
Strong team leadership and management skills

Senior Manager, Therapeutic Resume Examples & Samples

Prior experience in scientific communications (publications, congress management or medical communications) including development of cross-functional strategies/plans
Prior experience with health/scientific communication principles including the use of digital media
A strategic partner with a unique understanding of the interplay between Worldwide Medical and other departments, including, Commercial, Compliance, Legal, Regulatory
Ability to develop collaborative relationships with internal colleagues
Ability to be independent, multi-tasked and results-oriented with a hands-on attitude in a fast-paced and energetic environment
Strong team leadership and management skills

Therapeutic Resume Examples & Samples

Provide statistical-methodological expert advice and support metabolism project statisticians. Together with statistics line management facilitate the interaction and experience exchange among metabolism statisticians working at different sites and promote development of the statistics organization
Support project statisticians to ensure that clinical development strategies and key/pivotal trial protocols in metabolism are based on state-of-art statistical-methodology and meet regulatory requirements. Review and approve clinical development plans and protocol outlines
Participate in the interpretation and discussion of key/pivotal trial results, particularly for the statistical exploration of unexpected findings
Liaise with the Therapeutic Area Head Medicine Metabolism and represent the statistical function in strategic clinical decision making committees
Provide statistical expert support for regulatory interactions and clinical submission documents and attend regulatory meetings to support the project statistician, if needed. Review and approve clinical submission documents
Lead the development of standards for inferential statistical methods in metabolism. Monitor the clinical and regulatory environment for innovative, efficient methods with impact on current or future trial and projects
Lead the statistical-methodological review of in-licensing material and participate in due dilligence activities
Build strong partnership with academic, regulatory and industry expert statisticians and KOLs to bring in state-of-art statistical methodologies, critical trial design ideas and development strategies to BI

Therapeutic Resume Examples & Samples

Provide statistical-methodological expert advice and support oncology project statisticians. Together with statistics line management facilitate the interaction and experience exchange among oncology statisticians working at different sites and promote development of the statistics organization
Support project statisticians to ensure that clinical development strategies and key/pivotal trial protocols in oncology are based on state-of-art statistical-methodology and meet regulatory requirements. Review and approve clinical development plans and protocol outlines
Liaise with the Therapeutic Area Head Medicine Oncology and represent the statistical function in strategic clinical decision making committees
Lead the development of standards for inferential statistical methods in oncology. Monitor the clinical and regulatory environment for innovative, efficient methods with impact on current or future trial and projects
Build strong partnership with academic, regulatory and industry expert statisticians and KOLs to bring in state-of-art statistical methodologies, critical design concepts and development strategies to BI

Therapeutic Development Specialist Resume Examples & Samples

One-to-one communications with physicians and other health care professionals in support of approved indications
Provide education and assistance in the appropriate usage of company products
Prepare and implement a comprehensive business plan for territory
Organize promotional speakers programs in territory in partnership with RMLs and outside vendors
Territory financial management and reporting
Bachelor’s degree
5+ years sales experience in pharmaceutical/biotechnology industry preferred
Ability to develop and effectively manage new and existing customer relationships. Such relationships include key Hematology/Oncology clients (Physicians, nurses, health authorities) and reimbursement stakeholders. Existing strong relationships are a big plus
Demonstrates understanding of Hematology/Oncology therapeutic area, products and marketplace
Has a passion for the Hematology/Oncology business and understands the importance of the patient
Demonstrates superior knowledge of local healthcare system processes including reimbursement
Possesses a strong work ethic, ability to set priorities and manage time appropriately
Works with all members of the team appropriately in order to accomplish corporate and individual objectives

Head, Therapeutic Resume Examples & Samples

Monitors and analyses market and environment for Women Health products
Supports and follows KPI’s of current operations, coordinates new product launches to achieve company objectives in top and bottom lines
Prepares marketing strategy for Women Health products and communicates it to commercial management and business development partners
Organizes regional promotional events
Collaborates with key opinion leaders to understand and shape the market
Provides guidelines, brand identity materials and support best practices transfer among countries
Support countries for strategies creation by participating in major business planning processes
University level education or equivalent
Minimum 3 proven years of experience in regional marketing role
Experience with marketing of brands and/or branded generics
Analytical skills
Proficiency in speaking, comprehending, reading and writing English is required

Therapeutic Resume Examples & Samples

Executing and delivering the late development pipeline from proof of concept to approval and successful market access
In collaboration with Research and Translational Medicine, executing and delivering the early development pipeline, from pre-candidate stage to proof of concept
Insuring rigor of evidence generation strategies to maximize product target value
Anticipating and mitigating risk
Monitoring project progression, developing anticipatory plans to address potential variance to timelines and budgets
Direct management and oversight of Global Project Teams/Global Project Heads
Managing financial and human resource allocation, working with global platform leadership to insure sufficient resources allocated to effectively execute against approved plans
Developing best in industry talent to deliver on pipeline and support global Development organization
MD or MD, PHD
10 + years of industry experience in clinical development with deep diabetes therapeutic expertise and a successful track record in leading projects through development, registration, approval and successful market access
Experience managing direct and indirect reports
Substantial history of clinical development leadership, with Comfortable dealing with ambiguity and change
Hands on experience of re-building and re-shaping a development group
A positive, motivational and enthusiastic leader who is driven by the need to ‘make a difference’ to the organization and to the diabetes world
Academic position in the past is an asset with participation as a principal investigator in clinical trials recommended
Scientific research background preferred (PhD or equivalent a plus) with experience in translational medicine
Proven success at managing groups- academically or in industry
Experience in rare diseases preferred
FDA and EMA interactions (FDA panel, meetings, scientific advice, oral explanation etc) supporting multiple submissions
Experience in different geographies

Senior Director, Lead Therapeutic Resume Examples & Samples

Medical qualification (MD)
Specialty training required; board-certification in rheumatology (or dermatology) preferred
Several years (7+) of experience in the pharmaceutical industry, CRO or equivalent with significant clinical development experience in Phase 2 and 3 in the rheumatology area
In-depth knowledge of Pharmaceutical industry and related business compliance
Experience as medical expert in interactions with regulatory authorities
Experience in leadership roles (matrix environment, managing people)
Experience in start-up environment
Strategic thinking, with problem-solving ability, customer focus and a recognized commitment to quality
Excellent interpersonal skills and ability to communicate effectively with internal (including senior and executive management) and external key stakeholders (including regulatory authorities)
Strong team player with ability to lead in matrix teams in global and diverse environment
High performer, ability to work independently to solve complex problems and ability to support multiple projects as medical expert
Strong data-driven thinking and ability to interpret medical/scientific data and clinical relevance
Passionate to ensure medical and scientific excellence and creation of differentiated patient value through clinical development
Flexible and adaptable working style
Strives to have fun at work while creating value for patients

Lead Therapeutic Resume Examples & Samples

Medical qualification (MD)
Specialty training required; board-certification in rheumatology (or dermatology) preferred
Several years (7+) of experience in the pharmaceutical industry, CRO or equivalent with significant clinical development experience in Phase 2 and 3 in the rheumatology area
In-depth knowledge of Pharmaceutical industry and related business compliance
Experience as medical expert in interactions with regulatory authorities
Experience in leadership roles (matrix environment, managing people)
Experience in start-up environment
Strategic thinking, with problem-solving ability, customer focus and a recognized commitment to quality
Excellent interpersonal skills and ability to communicate effectively with internal (including senior and executive management) and external key stakeholders (including regulatory authorities)
Strong team player with ability to lead in matrix teams in global and diverse environment
High performer, ability to work independently to solve complex problems and ability to support multiple projects as medical expert
Strong data-driven thinking and ability to interpret medical/scientific data and clinical relevance
Passionate to ensure medical and scientific excellence and creation of differentiated patient value through clinical development
Flexible and adaptable working style
Strives to have fun at work while creating value for patients

Global Therapeutic Resume Examples & Samples

Provides strategic direction to the Hematology/Oncology group across all regions
Monitors to ensure the timely execution of trials with a focus on quality deliverables. Troubleshooting and contingency planning when necessary
Provides leadership to staff --- guides overall operations and management of resources to allow for growth of the department and the staff through performance planning, coaching, and mentoring
Responsible for human resource management to include hiring, promotions, and terminations
Partners with Business Development in the procurement of new business by reviewing proposals, making presentations to potential clients and representing PPD at appropriate professional meetings and conferences
Ensures that clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards
Maintains proper communications and relationships with other departments and interacts with sponsors to ensure communication and good customer relationships
Bachelor’s degree in life sciences
At least 10 years experience in clinical research which includes at least 7 years project management experience
Or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities
Valid Passport, where appropriate
Strong business/commercial judgment including business development skills
Excellent oral/presentation and written communication skills
Strong influencing and motivational skills
Strategic planning and organizational skills
Extensive knowledge of the clinical trial process
A thorough understanding of FDA, GCP, and ICH guidelines
Track record of success in the liaison role with sponsors
Expertise in budgeting and resource management
Effective leadership skills and proven ability to build high performing teams
Effective negotiation and problem solving skills
Strong writing and computer skills

Group Therapeutic Resume Examples & Samples

Provides strategic direction to the Infectious & Respiratory Disease group across all regions
Monitors to ensure the timely execution of trials with a focus on quality deliverables. Troubleshooting and contingency planning when necessary
Provides leadership to staff --- guides overall operations and management of resources to allow for growth of the department and the staff through performance planning, coaching, and mentoring
Responsible for human resource management to include hiring, promotions, and terminations
Partners with Business Development in the procurement of new business by reviewing proposals, making presentations to potential clients and representing PPD at appropriate professional meetings and conferences
Ensures that clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards
Maintains proper communications and relationships with other departments and interacts with sponsors to ensure communication and good customer relationships
Bachelor’s degree in life sciences
At least 10 years experience in clinical research which includes at least 7 years project management experience
Or equivalent combination of education and experience that provides the individual with the required knowledge, skills and abilities
Valid Passport, where appropriate
Strong business/commercial judgment including business development skills
Excellent oral/presentation and written communication skills
Strong influencing and motivational skills
Strategic planning and organizational skills
Extensive knowledge of the clinical trial process
A thorough understanding of FDA, GCP, and ICH guidelines
Track record of success in the liaison role with sponsors
Expertise in budgeting and resource management
Effective leadership skills and proven ability to build high performing teams
Effective negotiation and problem solving skills
Strong writing and computer skills
LI-MW1

Therapeutic Program Manager Resume Examples & Samples

Principles and practices of program administration and supervision
Federal, State and agency rules, regulations, and laws governing the practices of therapeutic interventions and treatment within a long-term facility
Principles, practices, and techniques of recreation therapy
Alternative therapeutic modalities
Physical, emotional, and psychosocial needs of the dementia patient
Community resources
Recruitment and training of staff/ volunteers
Establishing interpersonal relationships
Time management
Overseeing recreation therapy activities
Observing and assessing behavior and progress of patients
Developing and carrying out patient behavioral care plan within an interdisciplinary team concept
Supervision/leadership
Observe and assess the needs of the patient and apply the appropriate non-medical therapeutic modality
Develop therapeutic relationships with clients
Work weekends and /or holidays

VP, Global Therapeutic Resume Examples & Samples

Identifying strategic client opportunities
Client pipeline analysis
Identifying drug product opportunities
Partner with business development to implement specific strategies to grow therapeutic area book of business
Evaluating and integrating PPD's service offerings, such as
Phase 1 first in human testing capabilities
Clinical trial operations expertise
Regulatory intelligence expertise
Laboratory capabilities (including biomarkers)
Imaging capabilities
Post-approval studies and outcomes expertise
Special services - i.e. DSMB management, ARO partnership
Currently leading the Neuroscience therapeutic area for a top 5 CRO
Has led the Neuroscience development division of a pharmaceutical company or biotechnology company with a significant neuroscience pipeline
Has held a tenured position at a major US Neuroscience institution and is an internationally acknowledged "clinical trialist" with at least TWO of the following
Lead investigator on at least 20 Neuroscience trials of substance
Mega-trial experience, including steering committee membership
Member of an ARO at some stage of career
Advisor to FDA or EMEA
Former member of an FDA therapeutic advisory committee

Therapeutic Development Specialist Ottawa Resume Examples & Samples

Promotion and sales of company products within a defined territory or region
Territory analysis of past and present sales trends and costs
Organizing promotional speakers programs in territory in partnership with RMLs and outside vendors
Provide customer support in the implementation and management of Celgene drug safety initiatives
Champion Celgene values
Proven pharmaceutical sales track record that demonstrates top sales accomplishments
Bachelors degree in Business or Science; 5+ years sales experience in pharmaceutical/biotechnology industry
Bilingual (English & French) preferred
Ability to develop and effectively manage new and existing customer relationships. . Existing relationships with Rheumatolology and/or Dermatology clients (physicians, nurses) would be advantageous
Demonstrates the ability to understand and communicate technical clinical material clearly and effectively
Demonstrates understanding of specialty care and/or biopharmaceutical products and market. Experience in the Rheumatology and/or Dermatology therapeutic area would be an asset
Has a passion for specialty care and understands the importance of the patient
Drive to succeed and ability to adapt rapidly to an evolving and challenging entrepreneurial environment
Has the know how to plan and execute effective and successful CME activities
Demonstrates innovation and the ability to integrate innovative concepts from others into local plans

Therapeutic Resume Examples & Samples

At least 5 years experience
In Health Care Industry
Sound understanding or qualifications in marketing related principles
Strong sales track record
Comprehensive industry knowledge
Good in English
Good knowledge of computer based programs including spreadsheets and graphics
Continuous Improvement behavior

Therapeutic Recreator Supervisor Resume Examples & Samples

Candidates may substitute U.S. Armed Forces military service experience as a commissioned officer in Physical Therapy classifications or Physical Therapist and Medical Specialists specialty codes in the therapeutic field of work on a year-for-year basis for the required experience and education
Employees in some positions may be required to operate vehicles which require a specific motor vehicle operator’s license valid in the State of Maryland
Employees in this classification may be required to successfully complete cardiopulmonary resuscitation training and maintain current certification
Employees in positions at facilities with a swimming pool may be required to obtain Red Cross instruction and certification in Life Saving and Water Safety prior to permanent appointment

Director Heor-real World Evidence Analytics & Therapeutic Lead Resume Examples & Samples

Build and implement the strategic vision of the real-world evidence function within HEOR
Partner with healthcare delivery system/data provider entities on initiation of real-world evidence studies
Collaborate with HEOR colleagues and other cross-functions to execute real-world evidence programs
Drives the introduction of new real-world evidence capabilities and methodologies within the company
Ensures new and innovative data sources/quantitative approaches are implemented as appropriate
Leads the communication plans for real-world evidence studies within and outside of Mallinckrodt
Emerge as an internally and externally recognized expert in real-world evidence through engaging and presenting at scientific conferences and delivering on high impact publications in this area
Become a company spokesperson regarding publication/presentation of real-world evidence study results

Global Solid Tumor Therapeutic Resume Examples & Samples

Actively participates in advancing and communicating corporate and GMA philosophy and agenda. Participates as a member of TA Management. Coordinates induction, mentoring, training, and development of team. Identifies training needs
May supervise 2-10 employees, including other MDs or PhDs. Responsible for all aspects of talent management for own team and provides feedback as part of TA management
May assist in developing/mentoring junior medical affairs staff
Participates in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and adhoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies
Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE’s & SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities
All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams
Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities
Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects
May act as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities
Oversees scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource. May develop scientifically accurate marketing materials, medical education programs, advisories, and symposia. Maintains an up-to-date analysis of competitor product information
Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc. May act as medical/scientific leader for several programs within an area
May represent the medical function on cross-functional integrated teams for medical affairs activities
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions
Drives Medical Affairs strategies and is a key internal contact/subject matter expert
May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function
Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities

Executive Medical Director Therapeutic Area Resume Examples & Samples

Lead US Medical Office Therapeutic group, including medical directors and matrix team(s). Responsible for direct line managing of medical directors and other direct reports as required
Lead and direct the medical responsibilities by providing scientific insight and development of strategy for the given products within assigned portfolio by leading, or actively participating in cross functional teams to realize Takeda’s overall vision
Serve as US Medical Office medical and scientific expert for products within assigned therapeutic area and represent US medical affairs on governance committees as appropriate
Work within the US Medical matrix organization and is ultimately accountable for all medical affairs strategic and execution deliverables for all products in assigned portfolio
Form integrated partnerships with the corresponding US business Unit and the TPUSA Managed Market Organizations
Interact internally with and support Alliance Management, Business Development, Government Affairs, Managed Markets and Marketing & Sales
Form integrated partnerships with R&D therapeutic area(s), providing US Healthcare system medical insights into ongoing and planned development programs
Interact internally with senior level management requiring negotiation to guide the overall activities of the specific product(s) and therapeutic area
Manage the Medical Affairs budget for assigned products within theUS Medical Office therapeutic area
Provide oversight medical review, direction, and sign off of promotional pieces processed to the DDMAC Regulatory Affairs committee
Provides scientific leadership in guidance of strategy development for products/therapeutic area
When requested, provide input to confidential New Business Development opportunities within the therapeutic area of expertise of the director
MD degree with either industry or academic research experience; or equivalent combination of experience
Life cycle management experience

CNS Therapeutic Resume Examples & Samples

Acts as a key interface between the CNS Drug Discovery Unit (DDU) and Therapeutic Area Unit (TAU) to ensure portfolio prioritization and seamless transition of programs between research and clinical development, as part of the overall Asset Strategy of the Global Project Team (GPT)
Drive projects to rigorous assessments of therapeutic success or failure by testing clear scientific hypotheses as early, leanly, directly, and quickly as possible by the POM / POC stage of development
Leads Clinical Subteam of GPT to provide the key pivot of POM / POC that informs future scientific, medical, and business program approaches and Go/NoGo decisions
Engages early (at lead optimization stage) with CNS DDU to assist in research portfolio prioritization, based in part on translation strategy
Provides early clinical expertise and recommendations to DDU on go/no-go decisions at candidate decision gates
Serves on (and/or Leads) the Translational Subteam of the GPT to support biomarker, imaging, and/or pharmacogenomic strategies and implementation
Creates the Early Clinical Research Plan (ECRP), integrating input from other functions across TREC (as needed), including Translational Biomarker Research, Imaging, Quantitative Clinical Pharmacology, Early Clinical Operations, and Genomic Medicine
Coordinates with other functional experts within TREC to utilize all modalities required to accelerate or enhance the decision making process
Designs and implements clinical protocols for first in human studies through POM and/or early POC
Ensures that critical TREC experiments deliver timely Go/No-Go decisions
Engages CNS TAU during ECRP creation to ensure early clinical studies support decision making for late phase development
Contributes to authorship, review and approval of other key documents, including investigator brochures and INDs/CTAs as well as co-authored publications in scientific journals
Ensures agile, timely management of issues arising from ongoing studies, including serving as the study physician for adverse event reporting
Works closely with early clinical operations, quality, procurement, and contracting groups to support study team implementation of early phase clinical studies
Provides clinical expertise for early phase external opportunities and participate in due diligence teams
MD, MD/PhD preferred
Formal clinical training, including fellowship training with CNS specialization as well as translational/experimental medicine expertise preferred
Clinical development experience should be in academia and/or industry including early clinical trial design and implementation, documentation / filing
Discovery/basic research experience is preferred
Academic clinical experience is preferred
A rigorous record of scientific publication is required
Minimum 3-10 years biopharmaceutical/CRO health-related consulting company/academic industry early clinical development experience
Distinctive ability to engage in discourse on innovative drug discovery from early preclinical through to late-stage development
Skills
Driving results is essential. Need to be able to motivate individuals in a cross-functional, matrixed organization and project team setting, to achieve and exceed goals by establishing accountabilities, clarifying performance expectations, agreeing to high standards and measures, monitoring and reviewing performance, and providing timely and relevant feedback
Demonstrated strategic thinker with an ability to create and drive a shared understanding of a long-term vision
Planning, priority setting, and time management are essential
Accountability – takes responsibility for their own performance and accept full ownership of issues, problems, and opportunities, regardless of the source
Comfort with ambiguity is required
Demonstrated creativity and innovation, including ability for divergent thinking and the propensity to question to traditional methods, processes, and products, as well as build on others' ideas
Excellent communication, interpersonal sensitivity, and negotiating skills
Team-work, partnership and collaboration skills
CNS-related clinical expertise
Basic and clinical science of CNS pathophysiology
Translational medicine, including biomarkers
Nonclinical and clinical drug discovery and development
Regional/global Regulatory requirements
GCP/ICH

GI Therapeutic Resume Examples & Samples

Driving projects to rigorous assessments of therapeutic success (or failure) by testing clear scientific hypotheses as early, leanly, directly, and quickly as possible by the early POC stage of development. This pivot informs future scientific, medical, and business program approaches
Early engagement with Drug Discovery Unit (DDU) to assist in research portfolio prioritization
Provide early clinical expertise and recommendations to DDU on go/no-go decisions at stage-ups
Creation of the early Clinical Development Plan
Study design and implementation of clinical protocols for first in human studies through early proof of concept/proof of mechanism
Ensure that critical TREC experiments deliver timely go/no-go decisions
Coordination with other functional experts within TREC (e.g. quantitative clinical pharmacology, imaging and biomarkers) to utilize all modalities to accelerate or enhance the decision making process
Engagement of GI Therapeutic Area Unit (TAU) to ensure early clinical studies support decision making for late phase development
Ensure seamless transition between research and clinical development, driving the early plan as part of the overall Asset Strategy in the GPT
Contributes to authorship, review and approval of other key documents, including investigator brochures and INDs/CTAs as well as co-authored publications in scientific journals
Ensure agile, timely management of issues arising from ongoing studies (e.g adverse events)
Work directly with global product teams and global clinical development teams to support biomarker / imaging strategies and implementation plans across therapeutic areas
Support the Working Groups that support the development and execution of teams’ biomarker and personalized medicine strategy and implementation plan
Work closely with early clinical operations, quality, procurement, and contracting groups to support study team implementation of studies
Provide clinical expertise for early phase external opportunities and participate in due diligence teams
MD, MD/PhD preferred
Formal clinical training, including fellowship training with GI specialization as well as translational/experimental medicine expertise preferred
Clinical development experience should be in academia and/or industry including early clinical trial design and implementation, documentation / filing
Discovery/basic research experience is preferred
Academic clinical experience is preferred
A rigorous record of scientific publication is required
Minimum 5-10 years biopharmaceutical/CRO health-related consulting company/academic industry early clinical development experience
Distinctive ability to engage in discourse on innovative drug discovery from early preclinical through to late-stage development
Driving results is essential. Need to be able to motivate individuals to achieve and exceed goals by establishing accountabilities, clarifying performance expectations, agreeing to high standards and measures, monitoring and reviewing performance, and providing timely and relevant feedback
Demonstrated strategic thinker with an ability to create and drive a shared understanding of a long-term vision
Planning, priority setting, and time management are essential
Accountability – takes responsibility for their own performance and accept full ownership of issues, problems, and opportunities, regardless of the source
Comfort with ambiguity is required
Demonstrated creativity and innovation, including ability for divergent thinking and the propensity to question to traditional methods, processes, and products, as well as build on others' ideas
Excellent communication, interpersonal sensitivity, and negotiating skills
Team-work, partnership and collaboration skills
GI-related expertise
Clinical science
Translational medicine, including biomarkers
Nonclinical and clinical drug discovery and development
Regional/global Regulatory requirements
GCP/ICH

Therapeutic Resume Examples & Samples

Strong post-marketing and investigational event and aggregate assessment/review/ documentation skills; must have experience is writing/oversight of Annual Reports, PSURs, Type II Variations, ad hoc query responses
Must have a strong working knowledge of US/EU regulations/ICH guidelines, and must be experienced in safety reviews of IBs, protocols, final clinical study reports, and summaries of safety
Experience in communicating with the FDA and other global Health Authorities
Global drug safety experience preferred
Ability to read, analyze and interpret scientific and technical journals
Must have very strong English language writing skills and mature verbal communication and presentation skills
Working knowledge of MedDRA coding and experience in developing case series retrieval strategies
Must understand pharmacovigilance-related information systems and operations issues; prior oversight of these functions a plus
Experience using a large-scale electronic data storage and retrieval system
Requires strong attention to detail in composing and/or proofing materials, establishing priorities, scheduling and meeting deadlines
Must be able to work in a fast paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands

Oncology Therapeutic Specialist Resume Examples & Samples

Develop and implement account business plans
Achieve sales and business objectives within the designated territory
Develop and implement integrated customer plans leading to Merck’s oncology product adoption in each assigned cancer centers
Develop and maintain expertise on institution decision-making processes related to healthcare, pharmaceuticals and oncology
Ability to engage in complex patient and disease management discussions
Ability to analyze, plan, implement and monitor
Ability to work cross-functionally and with peers in other territories
Travel may be required depending on assigned territory
Language: English (French is an asset)

Oncology Therapeutic Specialist Montreal & Trois Resume Examples & Samples

Develop and maintain expertise in the relevant oncology areas of expertise as required by the position
Launch KEYTRUDA® successfully in current and future indications
Collaborate with other Merck’s stakeholders in the development and implementation of strategies and tactics to secure and improve reimbursement as well as to ensure optimal listings and usage for Merck oncology products in the assigned institutions
Establish and maintain contacts with key institution stakeholders (including, but not limited to, Medical Oncologists, Hematologists-Oncologists, Oncology Pharmacists, Oncology nurses) in order to adequately assist in the design of usage protocols and care pathways
Work collaboratively with Merck’s personnel (Marketing, Institutional Key Account Managers , Patient Access, Medical Affairs) to appropriately address customer needs and ensure that Merck delivers on its objective of becoming a trusted partner in demonstrating value and improving patient health outcomes
University degree, healthcare management, business or sciences
Minimum of 3 years of sales experience working with key stakeholders or high influence customers in hospitals including an expertise in Oncology or in Hematology
Able to establish networks and influence through these networks
Understanding of the provincial health care system, drug reimbursement environment and key oncology stakeholders in the assigned territory
Knowledge of current and evolving landscape by payer, (patient reimbursement assistance programs, hospital listings and treatment protocol requirements and other processes) and impact on effective patient and practice management
Strategic thinking skills
Proficiency in office technology and related software
Language: Bilingual (French / English)

Therapeutic Resume Examples & Samples

Actively participates in advancing and communicating corporate and U.S. Medical Affairs philosophy and agenda. Participates as a member of TA Management. Coordinates induction, mentoring, training, and development of team. Identifies training needs. May supervise 2-10 employees, including other MDs or PhDs. Responsible for all aspects of talent management for own team and provides feedback as part of TA management. May assist in developing/mentoring junior medical affairs staff
Participates in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and adhoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies
Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE’s & SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities
All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams. Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities
Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. May interact with and coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects
May act as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities
Oversees scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource. May develop scientifically accurate marketing materials, medical education programs, advisories, and symposia. Maintains an up-to-date analysis of competitor product information
Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc. May act as medical/scientific leader for several programs within an area. May represent the medical function on cross-functional integrated teams for medical affairs activities
Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions
Drives Medical Affairs strategies and is a key internal contact/subject matter expert. May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function. Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities

Associate Director, Portfolio & Therapeutic Resume Examples & Samples

Operations Management: Partner with SVP of Cardio-metabolic and Oncology and the east coast counterpart to drive realization of strategic and operational intent for the therapeutic area (TA) and the Organization
Minimum of (7) years experience in a Pharmaceutical/Biotechnology Industry to include experience in Biology, Biological Sciences, etc
Knowledge of discovery laboratory layouts and equipment requirements
Strong Project and Portfolio Management skills with experience managing major projects crossing organizational boundaries; proven ability to effectively keep teams, projects, and assignments on track and raise issues in a timely fashion
Highly dedicated, motivated, resilient, and flexible, capable of problem-solving and delivering on goals and objectives in a timely fashion in a scientific business model setting
Excellent team player who is able to work closely with fellow Ops Leads collaboratively and synergistically towards common portfolio and objectives
Excellent interpersonal skills to establish good working relationships and collaborate with networks of employees of all levels and personalities; able to foster cooperation in others; creative problem-solver
Excellent communicator who knows when and how to speak up and appropriately raise issues to appropriate stakeholders and to management; keeps both team members, colleagues (as appropriate) and management fully apprised of project / initiative status and issues
Have a strong mind set in operational excellence, able to develop plans which translate strategic objectives into executable actions and results and deliver on objectives
Knowledge of Cardio-metabolic and Oncology
Project Management certification / training and / or coursework & training in Project Management

Manager, Therapeutic Resume Examples & Samples

At least eight years of experience in communication or related field, preferably in a healthcare company, NGO, government agency or public relations agency
Demonstrated ability to develop compelling stories, with superior Japanese and English written, oral and visual communication skills
Experience building working relationships with key stakeholder groups, including national and local lay, professional/trade and social media, patient advocacy and industry associations and coalitions
Ability to write and present clearly and persuasively in English
Demonstrated analytic ability
Deep understanding of digital and social platforms
Ability to maintain perspective and bring positive attitude and courage to partnership discussions
Professional maturity and ability to work effectively across levels, functions, regions and backgrounds
Ability to stay aligned with overall strategic direction while applying diligence and attention to detail in execution and reliably meeting deadlines
Live Our Credo – Models and integrates Our Credo principles into his/her work. Seeks opportunities to foster dialogue and to support a Diversity and Inclusion mindset and behaviors
Connect – Influences stakeholders by applying insights to understand and deliver critical business needs. Models collaboration and teamwork and leads with a One Team mindset and approach to reach the best outcomes
Shape – Proactively uses insights to create tailored and targeted change communication plans that inspire ownership, engagement, and mindset and behavior change
Lead - Leads with strategic intent by prioritizing, focusing and efficiently managing solutions that enhance the J&J reputation and brand
Deliver - Demonstrates broad knowledge of the business and competitive environment and can translate global business realities into human realities. Executes communication plans and deliverables against key business metrics

AVP, Therapeutic Resume Examples & Samples

8+ years pharmaceutical (or related) industry experience in the US or global arena with proven track record of contribution to medical, clinical development or commercial strategies (in more than one therapy area is preferred)
Strategic thinking, specifically related to the development of Medical Affairs Goals and Strategies that address asset value proposition, insights from affiliates and regions, and clinical and value evidence
Customer expertise especially scientific leadership and other key stakeholders (public groups, government officials, medical professional organizations) in therapy areas
Proven ability to effectively influence company end-to-end life cycle management, data generation and evidence communication decisions
Excellent interpersonal, analytical, communication (written as well as oral) and results oriented project management skills
Strong judgment, prioritization and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies
Demonstrated ability to motivate, mentor, manage and provide clear, unambiguous expectations and priorities for the team – of own staff or through networks. Comfort and confidence in working with diverse teams and backgrounds
In a matrix environment, able to effectively collaborate with and influence partners across divisions; can collaborate with others to resolve conflicts across organizations
Travel = 30%

Therapeutic Resume Examples & Samples

Actively participates in advancing and communicating corporate and GMA philosophy and agenda. Participates as a member of TA Management. Coordinates induction, mentoring, training, and development of team. Identifies training needs. May supervise 2-10 employees, including other MDs or PhDs. Responsible for all aspects of talent management for own team and provides feedback as part of TA management. May assist in developing/mentoring junior medical affairs staff
Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects
Drives Medical Affairs strategies and is a key internal contact/subject matter expert. May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function. Ensures budgets, timelines, compliance requirements are factored into programs' scientific activites
Advanced degree (MD, PhD, DO) with relevant therapeutic specialty in an academic or hospital environment highly preferred. Relevant therapeutic area clinical experience and/or Medical Affairs in an academic, hospital or pharma environment required
National license to practice medicine with relevant therapeutic specialty in an academic or hospital environment. Academic qualification (Dr med or equal) is strongly preferred. Completion of residency and/or fellowship is preferred. Advanced academic qualification is warranted
Typically 8 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent
Proven leadership skills in a cross-functional global team environment. Ability to interact externally and internally to support global business strategy. Ability to run a complex medical affairs team(s) independently
Extensive knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols. Expert knowledge in a relevant therapeutic specialty. Must have basic understanding of Pharmacovigilance practices for Clinical Development programs
Demonstrated sense of urgency and strong goal orientation, an ability to make decisions and a history of meeting deadlines and objectives
Works independently and leads team
Can address complex problems within discipline or across several projects
Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions
Works on complex problems in which analysis of situation or data requires an in-depth evaluation of various complex factors

Therapeutic Manager Resume Examples & Samples

Develop Marketing Plan and Plan of Action for the Acute Stroke Business
Manage Strong Customer Engagement and Partnership to facilitate stroke business development
And align key accounts (all stakeholders) to achieve key objectives
Collaborate with CVN Sales team with strategic approach to achieve sales objectives consistent with company policies and product plans
Coordinate and align internal resources such as Medical, Marketing and Sales to fulfill customers' need and develop BI partnership in stroke management

Sales Manager Therapeutic Resume Examples & Samples

Co-creation of the BeNeLux Oncology, Frailty & Alzheimer strategy and Annual Operating Plans
Excellent execution of our Adults Therapeutic Area Approach in Be-lux
Direct management of the Belux TA adults Medical Reps team
Required experience/background: Masters degree
Industry and types of companies: minimum of 10 years Business experience in pharma or healthcare and minimum of 5 years Managerial experience at a national operating company
Strong preference for expercience in Sales management, Business development
Experience in Oncology is a plus
Languages: French/Dutch, English

Medical Affairs Therapeutic Resume Examples & Samples

Qualified Medical Doctor and experience in pharmaceutical regulations and R&D processes
Residency (or experience as internship) of Internal Medicine, Haematology, Oncology, Psychiatry/Neurology, Anti-Infectives and/or other medical specializations
Good communication and personal relationships skills
Leadership and motivation capabilities for specific projects. Able to gather and transmit information in a clear and simple way
Teamwork mind orientation
Organized and accurate in the execution of all tasks
Persistent, dynamic, creative, looking for opportunities and flexible
Able to use new technologies like the Internet as a valuable tool on his work.Medical Affairs

Director of Therapeutic Foster Care Resume Examples & Samples

Masters level
Must have at least 2 or more years experience in a supervisory role
Requires on call availability
Must demonstrate the ability to consistently and fairly supervise staff
Must have or complete IMPACT Training and be able to conduct and write home studies to certify foster families

Global Oncology Therapeutic Lead-geneva Resume Examples & Samples

Familiar with Covance internal processes and responsibilities of various functional areas
Client relationship experience
Ability to operationalize strategies
Understands and easily maneuvers and builds relationships within CLS and Broader Esoteric Network

Therapeutic Resume Examples & Samples

Accountable for setting TA goals in partnership with commercial
Accountable for TA strategy
Oversees TA strategic planning process
Approves global strategies and aligned operational plans built on customer insights globally to maximize the value of our asset/Brand to customers
Approves Lifecycle Plan initiatives and sequencing of indications
Accountable for setting TA business development strategy/priorities with commercial partner
Actively participant in KOL interactions and activities across TA
Serves as scientific expert for the therapy area, providing support to medical and scientific activities
Monitors global trends to identify opportunities for the asset/Brand
Supports key cross functional interfaces on TA and key asset/Brand issues including research, development, commercial and manufacturing
Maintains scientific and regulatory awareness to ensure that TA strategy reflect the latest scientific/medical developments and regulatory/commercial environment
Industry expertise in the relevant therapy area with an established KOL network
Minimum of 10-15 years drug development experience and expertise
Must have indepth knowledge of drug development and commercialization processes
Demonstrated expertise in oversight of global clinical programs in late phase development or post-approval in the pharmaceutical industry; successfully executed a major late phase development or post-approval program
Successfully interacted with regulatory agencies regarding indication and/or labeling issues
Significant cross-functional leadership/management experience
Knowledgeable of the commercial and environmental issues that drive asset/Brand success
Experience leading the strategy, planning, submission and execution of clinical trials preferred
Track record of high performance in a relevant discipline within pharmaceutical development and/or commercialization, with a preference for exposure in the therapeutic area of relevance
Experience leading development, medical or commercial teams
Experience managing the drivers of commercial value in a development, medical or commercial role
Experience with the process for developing a competitively superior product label
Demonstrated excellence in leadership behavior
Knowledge of regulatory review and response processes
Proven management and leadership skills
Demonstrated initiative, creativity, strategic capabilities, and strong analytical and financial management skills
Ability to work effectively in a cross-functional, matrix team environment
Able to independently formulate development or lifecycle strategy
Demonstrated understanding of the complexities and recent developments in the therapeutic area
Confident discussing scientific/mechanistic aspects of drug development, also comfortable in discussing commercial and regulatory issues
Demonstrated ability to present data, plans and strategies clearly and accurately to relevant audiences in order to obtain decisions
Strong understanding of the elements of drug development programs

Regional Therapeutic Resume Examples & Samples

Medical Degree (MD) with specialist qualification and experience in the relevant TA (Preferably CV and/or Osteoporosis)
Minimally 8 years of clinical development and medical affairs experience in a TA relevant to the position, 5 years of which should be from a pharmaceutical or biotechnology company Ability to function as an ethical, professional medical expert in a complex matrix environment
Good understanding of and, preferably, experience with demonstrating the value of medicines through health economic studies or modelling Strong scientific, medical direction and clinical research skills Good knowledge of clinical development and commercialization process In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials and non-interventional studies Ability to identify gaps within the body of knowledge that need to be filled in order to allow optimal positioning of Amgen products Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups Knowledge of Good Clinical Practices (GCP), EMEA regulations and guidelines, and applicable international regulatory requirements Understanding of resourcing and budgeting Proven ability to lead, manage, and motivate others in a complex, multi-functional, multi-national matrix environment Ability to effectively present ideas and document complex medical/clinical concepts in both written and oral communication Demonstrated ability to organize and lead expert Clinical Research Advisory Panels Have the skills to develop credible relationships with KOLs
The knowledge and skills necessary to perform the duties of this position are typically acquired through the combination of education, experience and knowledge or the equivalent

Immunology Therapeutic Resume Examples & Samples

Will determines the relevant gaps in the prioritized medical and scientific topics, creates and implements state of the art initiatives to address them
Leverages their in depth scientific knowledge and KOL relationships to identify opportunities for scientific growth
Partners with, acts as the CSLB medical spokesman and leverages their KOL relationships in the medical and scientific community to develop and execute medical strategy. The position holder will have a high awareness of patient needs, current therapeutic practices and new therapeutic trends in the US market. The position holder functions as the internal medical expert in supporting sales and marketing in developing strategies and implementing tactics
Responsible for increasing quality and relevance of all Medical Affairs led research (Investigator-initiated studies, Phase IV, Publications Research Grants) and publications
Provides Promotional Review Committee (PRC) oversight of the Pharm D Medical Information Scientist(s)
Partner and collaborate with and be the TA lead representing NA Medical Affairs with the global functions of Commercial Development, CRD, R&D, Global Clinical Safety & Pharmacovigilance (GCSP) and will serve on the Safety Management team for key US products
Responsible for developing, implementing, guiding and communicating the company’s Medical Affairs strategy and activities for the evolving assigned Therapeutic Area franchise. Drive the Therapeutic Area scientific agenda by focusing and aligning resources with key priorities in the region and globally
Serves as the lead scientific and clinical expert in the assigned therapeutic area(s). As the TA expert will provide input on labeling and regulatory strategy. Maintains in-depth understanding of disease states, assigned products, competitors, marketplace, related medical areas and regulatory guidelines. Closely monitors and evaluates medical literature for potential impact on CSL Behring products and initiatives. Insures that all MA staff working in their TA are current in their knowledge of relevant CSL sponsored clinical trial data and medical literature
Leads US publication planning function (pre and post launch) in assigned therapeutic area in collaboration with the global publication plan to drive TA Scientific agenda in alignment with strategic objectives
As the TA expert collaborates with Medical Information Specialists (MIS) to assure that standard response letters that are up to date, accurate, balanced and useful to health care providers. Anticipates queries that may arise with new product launches and establishes high quality and timely training of the entire field and in house Medical TA team (MTAL, MSLs, Field team leaders, MSMs and MISs). Serves as backup to MIS for promotional and educational materials working through the Promotion Review Committee and Medical Legal Review
Leads the planning and execution of Scientific Advisory Board meetings. Leverages scientific knowledge and KOL relationships to identify opportunities for activities leading to scientific advancement. Represent Company at scientific meetings
Acts as the lead therapeutic area medical expert and partner to Business Team (s) within US Commercial Operations and is responsible (in collaboration with the MTAL if applicable) for developing, executing, and communicating the cross functional Medical Affairs strategy and tactics for the evolving Therapeutic Area franchise
Develops and delivers scientific presentations to internal and external audiences (healthcare professionals, consumers, patient advocacy and support organizations, managed care organizations, sales force, etc.). Oversees and provides quality assurance for presentations and scientific exchange conducted by field-based MA team
Sets the scientific strategy for MSL field activities and KOL advocacy plans to build and maintain critical relationships and knowledge management for the responsible Therapeutic Area
Responsible for setting the strategy for US Medical Affairs supported research (Investigator-initiated studies, Phase IV, Publications Research Grants) and insures that this research is scientifically accurate, of high quality, relevant to key products needs and are completed on schedule and within budget
As the therapeutic area medical expert representing NA Medical Affairs partners with and shares their expertise with the global functions of Commercial Development, CRD, R&D, Regulatory affairs, Global Clinical Safety & Pharmacovigilance and may serve on the Safety Management team for key US products. Provides key strategic input to shape the portfolio strategy and global clinical development and risk management plans. Participates in global marketing, medical, and training meetings, including new product launches and publication planning
Collaborates with Corporate Communications to function as primary contact for US Commercial Operations Medical Affairs with national and international patient associations and organizations (organizations vary by therapeutic area). Education
Doctor of Medicine, with residency training preferably in North America. Exceptions to the North America requirement may be made for expertise (academic and clinical or pharmaceutical) in the applicable TA

Therapeutic Field Service Engineer Resume Examples & Samples

5+ years working in electronics or bio-medical technical repair. Respiratory repair experience will be highly desirable
Your qualifications must include a knowledge of the hospital protocol for the ICU, OR and NICU
Field Service and work experience in a Customer Service Environment highly desired. Previous experience with order entry, shipping, receiving & inventory control automated systems is required
Must have experience with Microsoft Word and Excel

R&D Finance Director for Infectious Disease Therapeutic Area Resume Examples & Samples

Support the R&D portfolio across Infectious Disease throughout the development cycle (Discovery through Launch) and provide financial leadership on the Infectious Disease Management Board
Develop and validate project assumptions and scenarios with project teams/functions. Prepare financial valuations for internal and external projects as well as partnering opportunities. Work closely with the L&A and Innovation Center finance teams on either supporting their efforts in new opportunities or having them support R&D’s efforts where the R&D team is leading the financial analysis on such opportunities
Partner with the Commercial, Strategy and Portfolio Analysis, and Project Management Organization teams to influence the prioritization of projects, create value, and drive growth throughout the R&D process. Key activities include the annual Long Range Financial Plan and semi-annual Portfolio Update
Support to Infectious Disease R&D functions including Research, Biomarkers, Clinical Pharmacology, Toxicology, and Informatics
Financial management of R&D Out Of Pocket (OOPs) spend and Operating Expenses (OPEX) to assure sound investments while seeking out cost savings opportunities
Develop timely and actionable information for annual forecasts, strategic plan, and actual results for the functions and projects
Oversee 3rd party financial transactions of collaborations for Infectious Disease. Partner with Business Development as needed
Assure financial compliance and control for Health Care Compliance, Sarbanes Oxley and Audit requirements
Lead & Develop a Finance team of 10 employees located in San Francisco CA and Beerse, Belgium
Identify and enhance financial data for decision support of Infectious Disease
A minimum of a Bachelor’s degree (BA or BS) is required
A major in Accounting or Finance or Economics is preferred
Master’s degree, MBA, CPA or CMA is preferred
A minimum of at least 8 years of relevant finance/accounting work experience is required
Prior people management experiences are required (individual should have multiple years of experience managing others)
A background from the healthcare, pharmaceutical or bio-tech industries is preferred
Must have strong financial analysis skills and ability to partner with people at all levels of the organization
Experience working with globally teams preferred
He/she will be required to travel within and outside the US of approx. 20 - 25%
The position is highly preferred to be located in San Francisco CA with qualifying consideration for Raritan NJ or Spring House PA.Finance

Clinical Therapeutic Resume Examples & Samples

Support TA Head in building the TA strategy, coordinate TAST monthly TC and face-to-face meetings (preparing meeting agenda, presentation and documenting minutes); coordinate activities between Brand lead and Clinical lead, provide support with AOPs and RDLT & TEC materials; support TA Head with operating TA team meetings, building agenda, collecting materials by working closely with other functional groups (clinical pharmacology, regulatory, clinical operations, project management) to draft minutes and develop action items; as well as any ad-hoc requirement from upper management
Collaborate and coordinate activities between the clinical department and several other business units: GCO, GMA, PhV, Project Leadership, Regulatory and GSD Management
1-3 years (BS/BA) or 0-1 year (MS,) working as a Clinical Study Scientist/Manager in a pharmaceutical industry environment or related area

Regional Therapeutic Resume Examples & Samples

Define strategy and develop the region (based on portfolio planning) to ensure successful and efficient trial allocation execution
Provide early input in protocol design from the region to optimize trial execution (recruitment, timelines, quality)
Develop regional strategy and support the countries in building strategic relationships with network of investigators
Support finding new investigational sites, as required by TA/MAF and future clinical trial demands
Build an appropriate knowledge base to execute future programs
Support good training on pathology and protocol for local teams
Provide regional input/represent the region in meetings and discussions on study placement/allocations (e.g. core review team meetings, working group meetings, scientific and operational review meetings, feasibility review meetings)
Provide PDO and TA/MAF consolidated regional input and identify elements for successful recruitment and country selection
Obtain consolidated country/regional input during protocol feasibility and provide proposal for list of countries from the region for site feasibility
Work with RTAEs from other regions to develop global recommendations for protocol and study placement
Help design critical feasibility questions to ensure successful trial execution (recruitment and quality)
Define regional commitment at the time of conduct of site feasibility and be accountable for consolidated proposal of country and site selection based on feasibility outcome for the region and applying regional efficiency criteria (regulatory and market access requirements, start up timelines, recruitment speed, productivity and quality)
Support PDO in building up and implementing recruitment contingency for the region in an assigned study
Support delivery of trial performance through mitigation activities as directed within the region
Share accountability with GCO Regional Heads for delivery of country enrollment commitments
Participate in Portfolio Review meetings for the trial/region
Possess a thorough knowledge of the TA landscape in the region
Possess in depth understanding of the pathology and knowledge of the developments programs (strategy, positioning of the product, competitive environment, etc.)
Possess a good understanding of the standard of care in the region, the different health care systems and relevant local regulations, is able to assess potential impact on TA programs, reference drugs and is able to advise PDO teams and TA on the future strategy for the region
Establish strong and productive relationship with PDO, the countries within the region and relevant non-GCO stakeholders e.g., MAF; and Commercial, Regulatory, Project Management Office (PMO) as required
Shape the direction in a new area, and build a new organization with limited guidance. Understand and adapt to different cultures and markets
A minimum of a Bachelor’s Degree is required. Advanced Degree (Master’s, MD or PhD) is preferred
A minimum of 6 years of experience with clinical research is required
Pharmaceutical industry experience is required
Immunology and/or Oncology experience is preferred
Solid knowledge of Global Clinical Procedures (GCPs) and relevant local regulations related to clinical research is required
Good scientific and medical expertise enabling peer-to-peer connections with Key Opinion Leaders (KOLs) preferred
Proficiency in English (reading, writing, speaking) is required
Multilingual (Spanish, Portuguese, French) preferred
Must have excellent written and verbal communication skills and strong presentation and analytical skills
Must have strong interpersonal skills and the ability to demonstrate leadership
Experience working in a global organization, across multiple countries, is required
The ability to provide Therapeutic Area, compound and protocol training within the region and lead local Investigator meetings is required
The ability to influence clinical research strategies to ensure successful execution of current and future clinical trials is required
The ability to collaborate with all levels of management and influence decision-making across a heavily matrixed organization is required
This position will require up to 20% domestic and international travel.Clinical Trial Administration

Oncology Therapeutic Specialist Resume Examples & Samples

Demonstrate a mastery of products’ clinical efficacy, articulate a strong value proposition for the customer, and provide patient and reimbursement support, while meeting or exceeding their sales goals
Utilize effective selling techniques and marketing strategies to create and expand demand for any/all promoted brand(s) for which you are responsible
Target, develop, assess and maintain a thorough understanding of key customers while maintaining a high level stakeholder position
Use strategic thought process in developing and maintaining an active customer database
Development of strategies to make excellent use of marketing materials and programs
Have a mastery of key account management, best practices and sales development
Develop exceptionally well designed business plans with resource allocations that link to strong business results
Demonstrate a mastery of knowledge and analysis of business, products, technical issues and the marketplace
Be extremely customer focused and able to build and foster strong positive relationships with key decision makers and opinion leaders
Arrange and coordinate effective promotional programs within all promotional and regulatory guidelines
Conduct essential field activities including but not limited to lunch and learns, customer in-services, attend tumor boards, etc
Work as a resource for various oncology organizations, teaching instutions, physician groups, oncology nurses, pharmacy directors, practive managers, navigators, etc…
Complete expense reports and other required administrative reports in an accurate and timely manner
Attend training programs, conventions, and symposia, as requested
Focus on the end results of the sales process, demonstrating personal accountability, sense of urgency and commitment to achieve business objectives
Exemplify strong collaboration and team work skills with internal and external stakeholders
Proactively use resources and share best practices that lead to achieving or exceeding business goals
Adhere to company compliance guidelines, policy and procedures
B.A. or B.S. degree
Minimum of 5 years of pharmaceutical, biotech, medical selling experience and with at least 3 of those years in Oncology
Start-up experience a plus
Existing relationships with key accounts within assigned geography
Strong track record of successfully hitting/exceeding sales goals to include national awards / President’s Club
Demonstrated success of selling in a territory where there was zero /limited impact from a co- promote partner or POD selling environment
Proven ability to formulate and implement effective oncology sales skills and results
Knowledge of oncology disease states products
Excellent written and oral communication skills and strong interpersonal, organizational, analytical and business skills
Proven ability to create and innovate, build and expand business and work both independently as well as in teams
Ability to quickly assimilate complex information
Knowledge of reimbursement
Knowledge of territory
Ability to travel as necessary or required, which may include overnight and/or weekend travel

Director, Therapeutic Resume Examples & Samples

Reports to: Therapeutic Area Vice President in Development
Professional collaboration and leadership skills
History of anticipating and resolving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and international regulatory requirements/guidelines

Japan Therapeutic Resume Examples & Samples

Support TA lead for J-TASTe activities and work with TA lead in order to
Integrate inputs from J-TASTe members
Make TA strategy in collaboration with related Japan Development Team Leaders (JDTLs) and other stakeholders
Communicate with global in order to manage pipeline and portfolio
Have perspective in TA portfolio from NME to Phase IV
Incubate and formulate initial, preliminary compound development plans for transition to Japan Compound Team (JCoT)
Explore new space based on TA strategy
Support TA lead for ensuring alignment with Global TA
Participate in communication with Global TA
Input Japan condition to global and obtain feedback to have alignment
Oversee each TA development in Japan and ensure the progress
Developing relationship with internal and external stakeholders: Support TA lead in order to
Communicate with BU head and other stakeholders in Janssen Japan. Develop credible relationship with internal and external leaders
Create external collaborations with academia and others
Align with business development activities in collaboration with TA lead
Provide scientific insights to License & Acquisition project teams
Assess potential compounds based on company strategies, future opportunities, and scientific value
Other duties as appropriate: Will be determined jointly between the analyst and the TA lead. In general, it is expected that such activities will support the TA lead in
Developing strategies that leverage Janssen Japan and regional capabilities to contribute positive value to the global program (beyond simple trial participation)
Having oversight of the TA strategy beyond drug development, e.g., in providing integrated health care solutions, such as drug-diagnostic combinations
Improving performance by strengthening the link between the TA lead and the various clinical science, commercial, and operations components of Janssen Japan
Providing more robust, higher-quality decision making and enhancing the reputation of Janssen Japan with our internal and external stakeholders, including investigators, KOLs, patients, regulatory agencies, payers, and the general scientific community
Qualifications
Experience in discovery/preclinical function in pharmaceutical company or research in academic setting is preferred
A minimum of 3 years Clinical Development experience in oncology is preferred. Especially experience in clinical development planning is preferred
Basic business skills, including making slides, and good presentation skills
Good communication skills to interact with various stakeholders (including Sales & Marketing, Medical Affairs, Business Development, HPMA, and etc,)
Good negotiation and conflict resolution skills, decision-making strengths, excellent communication and writing skills
Preferably have insight of Japan medical environment
Having good English skills1700156676W

Therapeutic Consultant Resume Examples & Samples

Ensures consumer and guardian participation in development of service plan and personal futures plan
Coordinates development of each person(s) served personal futures plan
Coordinates scheduling of team meetings (times, dates, locations, etc.) and informs all team members of such
Schedules and chairs screening for program vacancies
Develops waiting list for potential consumer vacancies
Develops and implements service plan within 30 days of moving in, annually, when significant changes occur, and when moving out
Demonstrates knowledge of contractual, legal and regulatory requirements
Monitors to ensure all service sites deliver services in accordance with contractual, legal and regulation requirements
Implements/coordinates any necessary plans of correction from a regulatory body
Demonstrates knowledge of ResCare mission and ResCare Quality Way by creating direction. Demonstrates organization’s commitment and leadership skills
Demonstrates knowledge of ResCare mission and ResCare Quality by customer focus. Demonstrates customer service orientation
Demonstrates knowledge of ResCare mission and ResCare Quality Way by face to face communication. Facilitates 1:1 interactions with peers, superiors, and subordinates
Demonstrates knowledge of ResCare mission and ResCare Quality Way by managing for outcomes. Is aware of quality indicators and achieves results
Demonstrates an understanding of person(s) served rights, protection, and safety
Monitors all incident reports to ensure patterns of incidents are addressed
Shares all incident reports with appropriate external agencies (area programs, social services, etc.) when necessary and appropriate
Participates in regularly scheduled regional safety committee meetings
Incidents of consumer abuse, neglect or mistreatment are investigated in a timely and thorough manner. Plan of Correction is initiated to prevent recurrences
Monitors/implements/supervises delivery of service plans and personal futures plan and training of staff
Ensures all written training programs are implemented and revised as needed
Documents consumer progress or regression. Initiates discharge planning if appropriate. Maintains records appropriately
Maintains fiscal spending within limits of approved budget; e.g. household expenses and repairs, vehicle expenses, personnel costs, consultant services, etc
Monitors worker’s compensation and unemployment claims for assigned service site(s). Is proactive in efforts to reduce claims and minimize risk/exposure of agency in these areas
Monitors all consumer finance documentation
Monitors budget variance reports to ensure accuracy
Implements/monitors compliance with ResCare Health and Safety programs
Attends industry functions to promote positive relationships with other providers
Develops positive relationships with all funding sources to promote new business
Uses leadership and communication skills to motivate team members toward agency objectives
Utilizes problem solving/mediation skills when employee to employee conflict arises
Monitors exit interview results and investigate areas of concern that may be identified through this process
Fosters team spirit and company pride among team members and agency
Manages budgeted staff hours to provide effective and efficient service delivery
Implements staff recruitment and retention programs to promote positive work environment
Espouse ResCare Mission and ResCare Quality Way
Oversee/participate in the hiring process of all assigned positions in accordance with ResCare policy and local, state, and federal employment law
Actively works toward achieving/maintaining Affirmative Action goals within assigned service site(s)
Ensure all assigned staff receives training and supervision as needed to meet performance expectations
Recognizes staff with Pro team, performance management evaluations, individual development goals, etc
Ensure assigned staff is evaluated fairly and timely in accordance with ResCare performance evaluation procedures
Ensures that all information from upper management is conveyed to employees as applicable and appropriate
Ensures that all job opportunity listings are shared with employees
Maintains and/or monitors training reports to ensure timely training of staff for all assigned service sites
525 Tiller Street Suite A , Logan, WV 25601-3438 USA

Therapeutic Resume Examples & Samples

Scientific and/or Business Graduate Degree
Proven skill in working with senior leaders
Proven skill in working with scientists and physicians
Influence and collaboration skills
Strategic and implementation skills
Medical Affairs experience (4-7 years)
Interpersonal skill to allow for successful interaction with peers and leaders across the organization in a matrix environment
Ability to create novel solutions to problems in a rapidly changing operating environment
Lead therapy area leadership team in the development and execution of the Respiratory medical matrix strategy, operational, and measurement plans
Partner with therapy area leadership team members to manage operational effectiveness, identify areas to improve cross functional working, and simplify processes. Act as key point of contact for the Respiratory TA on organizational strategic initiatives such as the HCPi and External Expert Management
Integrate asset and hub-level reporting and input to provide therapeutic area level information for therapy area head , therapy area leadership team, and organizational stakeholders, and facilitate needed interactions and connections between matrix team and central organizational management to ensure proper leveraging of reporting and analysis support
Work with BPMs to facilitate annual processes for developing medical strategies, operational plans and budgets for the TA
Lead preparation and provide facilitation for departmental, senior staff, and key stakeholder/partner meetings in support of TAH
Facilitate therapy area leadership team and therapy area Line Management Team meetings, including managing agenda, pre-meeting planning (collection of pre-reads and interactions with presenters), facilitating decisions, disseminating minutes and tracking/updating of actions
Manage partnerships and foster alignment with key enabling functions (e.g. finance, HR, commercial capabilities, CBI, enterprise field operations)
Coordinate and align TA leadership team decision making and action with US Pharma and USMA governance and operational planning processes
LI GSK

Global Therapeutic Resume Examples & Samples

Develops strong relationships and acts as trusted advisor to ID Therapeutics R&D Head, GCSO Leader, other SLT members and key scientific leaders
Coaches and guides leaders to develop their ability to engage and inspire their organizations and external audiences, in a diverse, global environment; serves on ID Therapeutics R&D Senior Leadership Team (SLT)
Leads development and implementation of integrated external and internal communication strategies for the global ID Therapeutics R&D business, aligned with GCPA goals and strategies
Drives meaningful business outcomes for ID Therapeutics R&D, Janssen and J&J, and sets appropriate direction based on deep understanding of the business, competitive environment and key financial levers
Leads/supports highly impactful, sensitive partnership, deal, TA/M&A, and other financial- and Investor Relations (IR)-related communication involving ID Therapeutics
Gains leader support and resources to realize high-value communications priorities
Counsels and influences constructively, challenges the status quo respectfully yet confidently, builds consensus and facilitates decisions to create long-term business value
Models and inspires integration of knowledge from internal and external networks; multi-stakeholder insights; and a broad understanding of the business, competitive and industry priorities to drive business and reputation outcomes, lead scientific positioning and issue management, and shape the environment for ID Therapeutics R&D’s medical solutions
Shapes team approach to proactively drive business and Enterprise outcomes by identifying and applying key outcomes metrics to communication practices, and provide insights that drive confidence, integration and alignment
Develops and guides implementation of executive leadership and engagement strategy, positioning senior leaders with key stakeholders
Maintains deep understanding of current issues in the global environment affecting the ID Therapeutics business and brands
Builds appropriate issue prevention, management and mitigation strategies in alignment with Public Affairs colleagues, local and regional teams, and appropriate external partners
Networks, builds and strengthens strategic relations on a global basis with crucial external stakeholders and influencers, including top global, regional and trade media, key social media influencers, core third-party influencers and other relevant external constituents
Oversees ID Therapeutics R&D communication budget and spending with the highest degree of fiscal prudence and responsibility; achieves annual goals & objectives within allocated budget
Helps the Janssen R&D Communication team to provide timely regional alerts, ensure appropriate processes for regional sharing and support, regional contacts and results monitoring
Ensures proactive global monitoring, analysis, prevention and management of ID Therapeutics related issues that may impact stakeholder trust and company reputation
Directly engages in, shapes approach to and globally leads and coordinates on issues involving scientific projects or brands, safety, clinical trial and regulatory issues, etc
Partners closely with Innovation, Global Health & Science Policy Communication, Janssen and J&J communication functions including Media Relations, Workforce Communication, Strategy & Insights and other groups to ensure enterprise-wide alignment
Serves as lead contact and spokesperson for top-tier and other media inquiries
Prepares, trains and coaches senior leaders and company spokespersons for sensitive media interviews, stakeholder meetings and other external engagements globally
Develops and implements global, multi-site, multi-culture workforce communications strategy and messages that inspire, engage, inform and align employees
Fosters and reinforces an authentic commitment to Our Credo; informs and shapes belief in our leadership imperatives to strengthen collaboration and teamwork
Leads and proactively coaches and develops a healthy, high-performing and highly engaged cross-IDV (Vaccines and Therapeutics) communication team of 3, promoting diversity, inclusion and ongoing personal development at all times
Models and inspires a continuous improvement mindset to ensure self and the team stay on the leading edge of communications, change management, technology, social and other key trends
Serves on Global Janssen R&D Communication Leadership Team (LT), the ID TA’s Senior LT, and further LTs and Extended LTs with opportunities to develop and influence cross-Janssen and J&J communication programs and interacting with top senior leaders and peers
Bachelor’s degree is required; advanced degree in Communications or Journalism preferred
Proven experience in Pharma R&D communication or public affairs required
Work experience in Infectious Diseases and/or ID R&D is preferred
Strong business acumen and demonstrated ability to build deep, authentic, successful relationships with top executives and scientists and strong influence with senior internal and external stakeholders is required
Minimum of ten (10) years of experience leading and managing communication in a company, NGO, government agency or public relations agency is required
Proven track record of successful, independent public relations/communications, corporate communication, science communication, product communication, public affairs, and/or media relations achievements is required
Global mindset and successful track record of working in a global function, with direct experience of leading on international projects, issues and teams, and of competent internal and external stakeholder interactions on an international basis is required
Demonstrated thorough knowledge of R&D processes and the global landscape and key issues for biopharmaceutical science and innovation is required
Broad understanding of competitive and industry priorities that drive business and social value is required
Demonstrated ability to lead, inspire and coach project teams and individuals is required
Strong experience in crisis/issues management and the ability to managing multiple priorities in a fast-paced, global matrix environment is required
Deep understanding of traditional media, digital and social platforms and a strong experience dealing with national and local lay, professional/trade and social media is required
Experience in managing budgets and resource allocation across large critical projects is required
This position will be based in San Francisco, CA and will require up to 30% domestic and international travel6081170323

Senior Therapeutic Resume Examples & Samples

Manages JBIO Therapeutic Area Leader (s) with dotted line responsibility for approx. 25 JBIO Team Leaders
Accountable for delivering on the robust strategic and scientific direction of the Target Molecule Profile through JBIO Team Leaders
Accountable for ensuring cross-JBIO scientific integration for all biologic assets in the portfolio
Mentor, help and support JBIO Team Leaders in the development of critical-path driven comprehensive project plans
Represent to the TA, the short, medium and long-term project needs to support and progress the JBIO portfolio. Represent JBIO on TA governance bodies as needed
Ultimately accountable for communication of scientific program/portfolio actions and recommendations between teams and across JBIO and the TAs
Ensure scientific portfolio readiness prior to BP, Strat Plan, DAS Milestone, Prioritization & DAS/CoE Review cycles
Ensure alignment of JBIO strategies to TA Goals & Objectives
Identify and implement cross-JBIO team efficiencies/process improvements/shared learnings
Ensure best practices sharing
Bring insights from external perspectives
Point of contact for Business Development / Innovation Centers / other groups involved in L&A to ensure visibility on associated resource and budget needs
PHD, with a minimum of 10 years of experience in drug development with industry or related (e.g. pharma, biotech, CRO, academic clinical research) leadership experience is required
Additional education and significant academic or industry research experience is desirable, (especially in biologics discovery and development)
The successful candidate must possess a proven track record of exceptional team management including the consistent demonstration of behaviors as defined in Leadership Imperatives (Live our Credo, Connect, Shape, Lead, Deliver)
Ability to interface effectively and positively with all levels of colleagues in research, non-clinical, clinical, regulatory affairs, CMC and marketing is required
The successful candidate will possess energy and enthusiasm and with the ability to inspire, mobilize people and teams is required
Team leadership is required
Experience in a heavily matrixed environment is strongly preferred
Ability to travel up to 10-15% yearly is required (International as well as Domestic) is required.6111170324

Medical Information Therapeutic Resume Examples & Samples

Strategy, Planning and Implementation: Develop, lead and drive the strategy, planning and implementation for the Medical Information (MI) organization in vaccines with the goal of enhancing functional excellence in Medical Information and fostering innovative approaches while managing risk. Responsible for establishing the strategic medical objectives and direction, short-term and long-term goals and leadership. Lead the overall planning and delivery of medical products and services from this function for their specified therapeutic areas/franchises for internal (GSK Response Center, Sales, Marketing, GSK Local Operating Company Medical Information functions and Field and HQ-based Medical Affairs Staff) and external (physicians, pharmacists, large payer and provider groups, managed care organizations) customers
Governance: Develop, lead and drive the strategy for vaccines to ensure medical governance and scientific accuracy of US Pharma promotional materials through the application of a robust and effective copy approval process
Risk mitigation: Lead and drive the strategy for vaccines mitigating risk, ensure that data communication is scientifically rigorous and balanced and complies with scientific exchange principles and emerging regulatory and legal requirements. Ensure compliance with all applicable corporate policies and standard operating procedures (SOPs). Guide the development of global processes and standards that enhance the ability of GSK to consistently and accurately meet medical information needs of external customers. Innovation: Develop, lead and drive the strategy to deliver innovative medical information content customer solutions/channels tailored to the voice of the customer
Medical Voice of the Customer (mVoC): Develop, lead and drive the strategy for vaccines to gather, synthesize and analyze mVoC such that it can result in actionable items by Medical Matrix Teams and Medical Commercial Strategy Teams to advance the medical strategy of GSK
Develop People: Develop, lead and drive the strategy to assure that people within the vaccines MI team are performing at the expected levels of medical competencies and GSK behaviors and develop them to perform above the expected level of medical competencies and GSK behaviors to improve overall performance

Therapeutic Field Service Engineer Resume Examples & Samples

Previous field Service and work experience in a customer service environment is highly desired. Previous experience with order entry, shipping, receiving & inventory control automated systems is required
Must have a minimum of Associate's Degree in electronics or bio-medical technical repair
Work performed at the customer's site requires sitting, standing and walking. Incumbent must able to lift and transport equipment weighing up to 50 lbs. as well as work with others on the physical movement of the equipment, which may include kneeling, squatting, crawling, twisting, bending and reaching. Fine motor skills are necessary for computer input as well as repairing electronic equipment and operating telephone, fax, copier, etc
Incumbent will be required to make frequent deliveries and pick-ups requiring driving
Position will include approximately 60-65% travel in a defined territory by van
Must possess a valid Driver's License

Director / Associate Director Therapeutic Resume Examples & Samples

Leads timeline and cost estimates development for clinical program lifecycle management
Assess and monitor the variance from plan across CDRA functional areas to determine any impact on the clinical development plan (CDP)
Drive Clinical Study Concept (CSC) completion
Strong interpersonal & leadership skills
Ability to provide strategic direction and guidance to teams aligned with clinical development plans
Anticipates new trends in a competitive landscape and therapeutic areas to guide the organizational strategy
Provides a comprehensive industry perspective for project management execution
Strong analytical skills with a data driven approach to planning, executing, and problem solving
Effective communication skills to all levels of the organization
Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
Accomplished influencing and negotiation skills
Proficient in creating and maintaining clinical program budgets and timelines
Exceptional project management, cross-functional team leadership, and organizational skills
Ability to build successful and effective teams and collaborations internally as well as with external partners
Line management experience with demonstrated mentoring and coaching skills
In depth knowledge of GCP and ICH
15 years relevant FDA regulated industry experience preferably with drug development; at least ten of which are in project management

Head of Core Therapeutic Area Resume Examples & Samples

1) Coach and enhance team members’ leadership skills and scientific and medical capabilities
2) Continuously optimize MSL and TAP working model, and improve MAF competency in collection of 3 Gaps and HCP insights
3) Establish close collaboration with cross functional teams, including marketing, business development, finance, supply chain, PDMS, regulatory affairs
4)Oversee the development of medical strategies that are aligned with business needs
5) Ensure funding for approved MA projects and oversee the budget planning and expensing process as well as project management
5) Ensure high quality medical review and approval of promotional materials that meet regulatory and company standards
7) Establish and maintain collaborative relationship with KOLs and medical societies
8) Maintain connectivity with global and AP teams (MA and CDT)

Therapeutic Technician Resume Examples & Samples

Demonstrates proficiency in the care of all ages: neonates, pediatrics, adolescents and adults
Performs designated pre-planned treatment activities, which may include functional and gross motor activities, whirlpools and aquatic therapy; assists in organization and implementation of summer group programs, etc,. under direct supervision of a licensed therapist and within the constraints of professional licensure laws
Assists therapist/nursing personnel where designated support is needed (such as transfers, ambulation practice, etc.)
Provides additional support to patients during Therapeutic Community Visits under the direct supervision of licensed personnel
Assists in monitoring patients in the rehabilitation area when requested
Fulfill responsibilities determined by department director. May include minor wheelchair adjustments (i.e., fill tires, adjust leg rests, etc.)
Maintains patient confidentiality related to conversation, medical records, treatment plans, etc
Maintains appropriate departmental charges and service delivery records; can act as billing back-up person
Uses machines and tools in a responsible manner, adhering to safety practices as outlined by the manufacturer and OSHA standards
Maintains equipment of supplies, orders therapeutic, medical, self-care and splinting materials under direct supervision of licensed personnel
Attends and participates in monthly program meetings, committee meetings/rounds related to patient treatment, program development and mandatory safety in-services
Responsible for participation in hospital programs for quality assessment and improvement, identifying opportunities to improve services, making recommendations and implementing actions as appropriate and consistent with the goals of the Nemours Foundation
Knowledge and ability to use computer systems – Lawson, Epic Cadence, maintain Excel spreadsheets, working knowledge of Word

Therapeutic Resume Examples & Samples

As a member of the PMO LT
Set vision & strategic directions, and build capabilities of the PMO
As a PMO Leader
Lead, coach and develop PMO Project Managers and drive continuous PM Excellence of staff
Actively identify, develop, and implement project management and team performance best practices providing SME support and facilitating pipe-line project workshops
Ensure high performing of global project teams by monitoring and assessing team effectiveness within own portfolio
Mentor early project team leaders and teams in preparation for CSP transition (as needed)
Support Global PMO Head in managing PMO budget
As PMO TA Head of a particular disease area and as a member of the Disease area Decision Board(s) / Leadership Team
Contribute to development of Disease Area (DA) strategy and decision making
Ensure alignment of a given DA with organizational strategy
Manage execution of DA strategy to progress DA portfolio (15 to 40 projects) and delivery of these projects to agreed milestones and ensure team’s implementation of board decisions
Drive portfolio prioritization discussion and cross-functional resource alignment
Providing key stakeholders with timely assessment of portfolio performance
Provide cross-functional drug development perspective to DA
Ensure that Line Function interfaces are optimal
Drive alignment with Development and plans to phase 2b, assessment of options, financial implications of different options and proposals for at risk investments
Ensure that Development considerations are taken into early development project plans and that transition to Development is smooth and as fast as possible
Responsible for the accuracy of early development portfolio information
Support global governing committees as part of interface, resource alignment, or prioritization efforts as required
Act as DADB secretary where appropriate
As a Project Manager, drive project strategy development, build project plans with options, risk mitigation and contingencies and provide proactive operational oversight of all aspects of the integrated project plan
At least 10 years of experience in Pharma or Biotech industry
Relevant professional experience in global drug development project management
Demonstrated experience in strategy development, option planning development, risk analysis, mitigation and contingency planning, and decision analysis
Demonstrated experience in global late drug discovery and early drug development; global later stage drug development is desirable
Extensive experience in leading / managing and driving global cross-functional teams
Demonstrated experience in engagement of senior stakeholders and at challenging the status-quo at management level
Experienced in management and personal development of direct reports
Experience in global matrix management role with demonstrated ability to influence successfully without authority
Budget management experience is preferred
Expert in all aspects of team behaviors; drives conflicts resolution in teams; good ability to modulate style
Advanced skill in facilitating/optimizing the contribution of diverse team members as individuals and as a team
Capable of quickly gathering high-level understanding of complex technical, medical and scientific issues and communicating this understanding in a clear way
Demonstrated global mindset and cultural awareness

Therapeutic Care Field Service Engineer Home Based Resume Examples & Samples

5+ years working in electronics or bio-medical technical repair. Respiratory repair experience will be highly desirable
Your qualifications must include a knowledge of the hospital protocol for the ICU, OR and NICU
Field Service and work experience in a Customer Service Environment highly desired. Previous experience with order entry, shipping, receiving and inventory control automated systems is required
Must have experience with Microsoft Word and Excel

Regional Therapeutic Resume Examples & Samples

1) Define strategy, develop the region (based on portfolio planning) to ensure successful and efficient trial allocation /execution
Build an appropriate knowledge base to execute future programs With central team, support good training on pathology and protocol for local teams
Obtain consolidated country /regional input during protocol feasibility and provide proposal for list of countries from the region for site feasibility
3) Has a thorough knowledge of the TA landscape in the region
Has a good in depth understanding of the pathology and knowledge of the developments programs (strategy, positioning of the product, competitive environment etc.)
Has a good understanding of the standard of care in the region, the different health care systems and relevant local regulations, is able to assess potential impact on TA programs, reference drugs and is able to advise PDO teams and TA on the future strategy for the region
4) Establish strong and productive relationship with PDO, the countries within the region and relavant non-GCO stakeholders e.g., MAF; and Commercial, Regulatory, Project Management Office (PMO) as required
Significant experience in the specific TA area assigned. MD/Phd will be advantageous
Preferentially more than 6 years of experience with clinical research and strong experience with the TA within the region
Based in one of the countries of the GCO region
Experience of successfully working a heavily matrixed organization. Able to lead and influence without direct authority
Exceptional networker. Connects easily and broadly across the organization and across countries. Is effective in working in a virtual global organization
Good scientific and medical expertise enabling peer-to-peer connections with KOLs
Broad experience in the pharmaceutical industry and drug development process
Good knowledge and understanding of Janssen R&D in general and PDO/GCDO in particular
Solid knowledge of ICH-GCP, GCDO SOPs and relevant local regulations related to clinical research
Capable of providing TA, compound and protocol training within the region as necessary (lead local Investigator meetings if needed)
Excellent interpersonal skills and ability to demonstrate leadershipInternal and external partnering; ability to build relationships across the business and externally; ability to influence clinical research strategies to ensure successful execution of current and future clinical trials
Strong problem solving ability
Able to identify opportunities for improvement and drive innovation in the region and in GCO organization as a whole
Ability to work in an international and diverse environment, with good cultural sensitivity
Big picture orientation with attention to details
Willingness to travel regionally/globally

VP, Global Therapeutic Resume Examples & Samples

Recognized medical qualifications with additional/fellowship training in oncology/hematology
At least 10 years of oncology drug development experience in a pharmaceutical/CRO environment
An accomplished global functional manager, who is recognized as a leader within the oncology clinical development community
Experience in strategic thinking and tactical planning to further prepare Covance’s oncology business for future success
Translates business vision and strategy into functional vision for staff
Develops an industry-leading medical staff – able to attract high-caliber talent and to build high performance teams
Pursues continuous learning and development for self and others
Provides mentoring to and assists with supervision of Executive Medical Director/VP (Section Head) Senior Medical Director, Medical Director, Associate Medical Directors, Assistant Medical Directors and others
Involved in identification, interviewing and selection of candidates for Senior Medical Director, Medical Director, Associate Medical Director, Assistant Medical Director and support staff positions
Involved in assignment of projects and specific duties to Senior Medical Directors, Medical Directors, Associate Medical Directors and Assistant Medical Directors
Responsible for administration and/or delegation of activities of his/her direct reports
10 or more years in drug development (pharmaceutical, biotech or CRO) – experience in Oncology required
3 or more years in clinical/academic practice preferred
Recognized as a clinical research leader within their therapeutic area
Demonstrated strategic focus and problem solving ability
Substantial knowledge of drug development

Oncology Therapeutic Specialist Resume Examples & Samples

Maintains and utilizes exceptional Oncology product knowledge and highly effective Customer Engagement skills in order to influence targeted Oncology health care professionals and institutions to support the use of BICL promoted products and achieve territory sales results
Executes brand strategies and business plans to ensure a consistent company sales, key account and marketing message
Establishes and maintains exceptional administration / communication / cooperation / coordination with internal BICL employees as well as with external stakeholders to achieve shared goals (e.g. patient advocacy groups). Fosters Oncology HCP network development and communication and seeks feedback on BICL strategies, tactics and value propositions
Supports Regional business needs through Integrated Customer Engagement, involving the National Oncology Manager, Marketing, Market Access, Medical teams, and other BI Internal support personnel in the development, management and accomplishment of key Territory business opportunities
Provides expert understanding of the Oncology Payer landscape. As a trusted Oncology consultant, encourages and receives requests from customers for expert technical information outside of standard visits. Through all these endeavors, develops trust and subsequent value with Oncology customers, including payers, hospital formularies and other important accounts
The Oncology Therapeutic Specialist manages territory budget that supports the development of Regional and Territory Oncology thought leaders, innovators and advocates to support BICL Oncology products. He/she assist in determining how to efficiently utilize Regional and National Speakers and other company resources in their territory by proactively working with the National Specialty Manager. Provides appropriate feedback and follow-up to Oncology speakers and attendees
A minimum of 5 years of successful Pharmaceutical sales experience, preference for candidates with Oncology or Specialty sales experience, (especially in NSCLC)
Ability to translate key scientific information supporting product, competitors, science and marketplace to a broad range of Oncology customers and accounts
Very strong abilities in the following areas: leadership, change management, coaching/training/development, verbal and written communication, emotional and social intelligence, analytical skills, business planning, and customer relationship management
Ability to travel with overnights and attendance at evening/weekend programs, as required

Associate Director, Therapeutic Resume Examples & Samples

Advanced scientific/medical training equivalent to PhD, PharmD and/or 6-9+ years of related industry experience
Prior experience in scientific communications (publications, congress management or medical communications) including development of cross-functional strategies/plans
Prior experience with health/scientific communication principles including the use of digital media
A strategic partner with a unique understanding of the interplay between Worldwide Medical and other departments, including, Commercial, Compliance, Legal, Regulatory
Ability to develop collaborative relationships with internal colleagues
Ability to be independent, multi-tasked and results-oriented with a hands-on attitude in a fast-paced and energetic environment
Strong team leadership and management skills

Associate Director / Director, Therapeutic Resume Examples & Samples

Works closely with the Therapeutic Area Head (TAH), Development Program Operations (DPO), TA Operations Lead, Clinical Trial Management (CTM) Operations Lead and Program Direction to ensure clinical study deliverables support clinical program goals and project execution
Works closely with the TAH, DPO and CTM Operations Lead to ensure the required deliverables are aligned with meeting the review committee objectives
Facilitate quarterly and annual resource forecasting across all CDRA functional areas

Manager Therapeutic Resume Examples & Samples

Participate with a One Team mindset to unify, collaborate and drive for best outcomes; collaborate across EMEA TA teams; facilitate sharing of best practices, common processes and procedures and consistency among all GCPA colleagues in the countries
At least 5 years’ experience in pharmaceutical brand/product and therapy area/franchise communications, either in-house or within an agency/consultancy
Expertise in core healthcare communications disciplines
High level of understanding of local legal and HCBI regulations and J&J Health Care Compliance
Strong technical competencies relevant to Brand/Product Communications, including issues management and proactive, compliant product communications
Ability to translate complex scientific data into communications materials
Experience and knowledge of a range of therapy areas
Knowledge of new models of communication including digital and social media
Experience working collaboratively in a matrix and/or global organization
Fluency in English1700182395W

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