Medical Affairs Director Resume Samples

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DB
D Botsford
Derrick
Botsford
4264 Joy Inlet
San Francisco
CA
+1 (555) 543 5941
4264 Joy Inlet
San Francisco
CA
Phone
p +1 (555) 543 5941
Experience Experience
11/2014 present
Houston, TX
Medical Affairs Director Immunology IBD
Houston, TX
Medical Affairs Director Immunology IBD
11/2014 present
Houston, TX
Medical Affairs Director Immunology IBD
11/2014 present
  • Networking and Collaborating
  • Quality Management
  • Project Management
  • Medical Strategy Development
  • In-depth knowledge with at least one product within TA including main competitors
  • Awareness of, and adherence to, Johnson & Johnson Credo values
  • Medical WritingMedical Affairs
07/2011 05/2014
New York, NY
Medical Affairs Director NAF
New York, NY
Medical Affairs Director NAF
07/2011 05/2014
New York, NY
Medical Affairs Director NAF
07/2011 05/2014
  • Member of the NAF Management team
  • Budget management
  • Develops together with team
  • Monitors actively MAF performance
  • Manages MAF budget
  • KOL Developments Plans
  • Quality of Medical Education events based on clear KPIs (NPS, Scientific evaluation)
09/2004 01/2011
Boston, MA
Medical Affairs Director
Boston, MA
Medical Affairs Director
09/2004 01/2011
Boston, MA
Medical Affairs Director
09/2004 01/2011
  • Provide therapeutic knowledge or expertise on business development projects and manage Medical Affairs transition process after deals completed
  • Per medical strategy, establish and/or enhance partnerships with key academic institutions and develop relationships with key thought leaders
  • Provide areas of interest and general information regarding the Merck Investigator Study Program process
  • Providing physician leadership for scientific communications, including standard responses and publications
  • Oversee the development and presentation of scientific data to internal and external audiences
  • Work with the Global Medical Team leader and Global Medical Team (GMT) to develop medical strategy, including e.g. in-line R&D LCM strategy, publications strategy, congress strategy, customer interaction strategy, and the scientific communication platform for the disease area / brand(s), aligned with product strategy
  • Support development of the in-year medical tactical plan and budget for the global initiatives and the United States
Education Education
Bachelor’s Degree in Biomedical Sciences
Bachelor’s Degree in Biomedical Sciences
The University of Texas at Austin
Bachelor’s Degree in Biomedical Sciences
Skills Skills
  • Excellent knowledge of the TA in general with a good knowledge of all products within TA
  • Possesses strong listening skills; ability to create win/win solutions; good sense of humor; viewed by subordinates as tough but fair
  • Ability to adapt easily to changing work environment; comfortable with ambiguity
  • Good knowledge of study execution, Global Medical Safety and regulatory affairs
  • Personable, likeable, engaging style that encourages a high morale and teamwork
  • Ability to convey, on a peer to peer basis, a therapeutic option in a fair, balanced and highly credible manner
  • Very strong and demonstrable communication and influencing skills that can impact at a Regional and Global level
  • Strong leadership skills, capable of driving a multi-cultural, virtual team
  • Exhibits integrity, honesty and a sense of personal accountability
  • Innovative with the ability to coordinate and drive a complex and changing environment
Create a Resume
1

Medical Affairs Director Resume Examples & Samples

  • 20% - Support definition of global medical strategy and plans
  • Work with the Global Medical Team leader and Global Medical Team (GMT) to develop medical strategy, including e.g. in-line R&D LCM strategy, publications strategy, congress strategy, customer interaction strategy, and the scientific communication platform for the disease area / brand(s), aligned with product strategy
  • As delegated by the Global Medical Team leader, participate in development of product strategy; provide medical affairs and R&D inputs for product(s) to Product Strategy Team
  • 40% - Work with Global Medical Team leader on in-year implementation of global medical strategy
  • A medical degree is preferred, PhD or PharmD + >10 year experience required
2

Medical Affairs Director Resume Examples & Samples

  • Work with the EMAP Team to gather input for the EMEA Medical Affairs Product Plan(s) for designated product(s) according to the EMAP Team charter
  • Draft the EMEA Medical Affairs Product Plan for allocated product(s) and drive the review and approval process with the EMAP team, EMEA Therapeutic Area Team (ETAT), the EMEA Medical Affairs Leadership Team (EMALT) and IBVT
  • Work with the EMAP Team to proactively identify and provide medical input into opportunities for new indications or lifecycle extensions for allocated product(s)
  • Work with the EMAP Team to develop approaches to support successful market access for allocated product(s) in partnership with HEMAR, the CDT (Compound Development Team) and lifecycle management teams
  • Leverage product(s) expertise, medical and market insight to shape and direct implementation of product(s) strategies and plans
  • Work with the EMAP Team and Medical Affairs functional network to drive the implementation of the Strategy and Plan
  • Ensure effective and regular communications between Global, Regional and local MA teams, including regular communications to help minimise duplication of clinical, advocacy and access programs across countries, and facilitate co-ordination between EMEA Medical Affairs, CDT, Strategic Marketing, HEMAR and individual countries
  • Work with designated EMEA SKM Product Specialist(s) to integrate and align Medical Information requirements with the EMEA MA Strategy and Plan
  • In-depth knowledge with at least one product within TA including main competitors
  • In-depth knowledge and hands-on experience of clinical trial design and study data analysis (e.g. statistical analysis)
  • Strong leadership skills, capable of driving a multi-cultural, virtual team
  • Awareness of, and adherence to, Johnson & Johnson Credo values
  • 5 + year industry / business experience with a minimum of 2 years experience in a relevant area for this function (e.g. Medical Affairs or Clinical R&D)
  • 1 – 3 year project management, team leader or functional line management experience
3

Medical Affairs Director Resume Examples & Samples

  • Develop professional relationships and communicate with national and regional thought leaders to ensure access to medical and scientific information on Merck products and areas of therapeutic interest
  • Conduct peer to peer scientific discussions and maintain a reliable presence with those thought leaders to ensure they have a medical contact within Merck
  • When needed, serve as a resource for the identification of potential investigators for consideration for participating in phase II-IV clinical development programs
  • Provide areas of interest and general information regarding the Merck Investigator Study Program process
  • Serve as a role model for other field medical team members, including on-boarding and/or therapeutic training partner
  • Attend scientific and medical meetings and support development of post-meeting deliverables
  • Provide clinical and scientific support for Health Systems
  • A minimum of 5 years of experience in Medical Affairs and/or Virology, Infectious Disease
4

Medical Affairs Director Resume Examples & Samples

  • Minimum of 5 years of experience in Medical Affairs and/or Virology, Infectious Disease
  • Valid Driver's license
  • 75% Travel
5

Oncology Medical Affairs Director Resume Examples & Samples

  • Minimum of (5) years’ experience and proven therapeutic competence in oncology and/or immunology
  • Thorough knowledge of Oncology clinical medicine, pharmacodynamics, pharmacokinetics, pharmacoeconomics, disease management, and medical research including investigator sponsored trials
  • Knowledge of clinical (patient care) or deep research experience in assigned therapeutic area(s) beyond that obtained in the terminal degree program
  • Must possess a thorough understanding of the FDA, OIG, HIPAA and other ethical guidelines, laws and regulations relevant to the pharmaceutical industry
  • Excellent interpersonal communication skills, ability to network, strong personal integrity, collaborative mindset, and a strong patient and customer focus are necessary
  • Must be able to organize, prioritize, and work effectively in a constantly changing environment, and have demonstrated project leadership abilities
  • Must possess a valid Driver's License
  • Field-Based Medical Experience
  • Clinical Practice and/or Research Experience
  • Experience in organized healthcare institutions/systems providing experience in developing peer-to-peer relationships with clinicians and scientific leaders
6

Medical Affairs Director Resume Examples & Samples

  • Partner with Senior Horizon Medical Affairs Management to advance corporate goals
  • Leverage clinical and therapeutic qualifications and experience to conceive, develop, and execute projects relevant to advancing the goals of the Medical Affairs Organization at Horizon
  • Provide therapeutic knowledge or expertise on business development projects and manage Medical Affairs transition process after deals completed
  • Communicate and partner with key external therapeutic experts (HCPs) to provide and support high level clinical education
  • Provide support to global sales team and customer base through effective resolution of medical and technical questions which cannot be answered by field service organization
  • Provide a medical perspective to clinical and regulatory organizations, provide subject matter expertise including the utilization of key clinical data and medical trends to effectively differentiate Horizon’s products and services to marketing teams to develop appropriate collateral materials
  • Develop and support key clinical and medical affairs strategies in conjunction with commercial counterparts. Provide ongoing and interactive technical and medical expertise to executive on these strategies
  • Publish in peer-reviewed literature and present at national and international health meetings on topics related to Horizon’s pipeline and commercial products
  • Interact and present to government, regulatory, and other stakeholders to promote enhancement of the corporation’s reputation
  • Demonstrate the required “intellectual horsepower” to be a credible expert and develop strong relationships with key opinion leaders, primary and specialty physicians, key professional societies and organizations
  • Provide expertise in the phase3b/4 development programs and lifecycle management activities for Horizon compounds within therapeutic area as well as business development opportunities
  • Develop publication plans utilizing internal and external data sources leveraging therapeutic knowledge and data analysis abilities
  • Deliver background scientific information and specific scientific project training to relevant internal stakeholders (sales marketing, business development, etc)
  • Lead departmental initiatives regarding support systems and processes to facilitate appropriate conduct and documentation of ongoing project work
  • Attend and support external medical meetings and conferences
  • Partner with Horizon Compliance to ensure activities, programs and projects are compliant and consistent with company policies
  • Medical degree required (MD or ex-US equivalent)
  • Relevant clinical therapeutic experience preferred; focus in inflammation/immunology a plus
  • 5 + years in Medical Affairs or Medical Affairs and Outcomes Research experience in a pharmaceutical environment
  • Experience with partnerships and strategic alliances is preferred
  • Knowledge of clinical trial development and direction
  • Outstanding oral and written communication skills
  • Demonstrates strong presence and is a “self-starter.”
  • Ability to convey, on a peer to peer basis, a therapeutic option in a fair, balanced and highly credible manner
  • Understands his/her audience; available and able to engage people with varying degrees of scientific background in a meaningful and clear dialogue
  • Demonstrates ability to relate and work with a wide range of people to achieve results
  • Able to demonstrate problem solving and risk mitigation skills
  • Possess a professional, proactive demeanor
  • Personable, likeable, engaging style that encourages a high morale and teamwork
  • Performs well under pressure; able to maintain composure in challenging situations
  • Is able to address issues/concerns in a clear, well-informed manner that engages others in a thoughtful discourse; able to stand up in a polite way and make the case
  • Exhibits commercial curiosity when evaluating new approaches and solutions
  • Understands operations and can prioritize for growth
  • Willingness to work in a multi-disciplinary team environment
  • Ability to adapt easily to changing work environment; comfortable with ambiguity
  • Proven outside-the-box thinker and strategist who champions taking calculated risks and embraces new methodologies that drive innovation
  • Ability to motivate and provide leadership in a growing enterprise; experience building, coaching, and leading teams
  • Exhibits clear executive presence, is easily recognized as a team leader in a group environment
  • Exhibits integrity, honesty and a sense of personal accountability
  • Possesses a well-cultivated self-awareness
  • Track record of managing conflict resolution with equanimity
  • Demonstrates ability to serve as corporate spokesperson; capable of representing the company on a global basis in high visibility settings; possess the talent to quickly establish credibility within the business community
  • Possesses strong listening skills; ability to create win/win solutions; good sense of humor; viewed by subordinates as tough but fair
  • Proficient in office based computer skills including Word, Excel, PowerPoint, etc
7

AP Regional Medical Affairs Director, IDV Resume Examples & Samples

  • Support the development of AP IDV Annual Business Plan
  • Assist Neuroscience and IDV TA Lead in budget management
  • Ensure excellent prelaunch preparation for pipeline products
  • Excellent knowledge of IDV in general with a good knowledge of HIV, Hepatitis, Tuberculosis and Influenza
  • Sound knowledge of study publication processes and publications
  • Highly customer and market place focused with an “big picture” orientation
  • Fluency in additional AP languages an advantage
  • Awareness of and adherence to Johnson & Johnson Credo values
  • Medical degree and higher medical qualification essential
  • IDV experience an advantage
  • 5+ years experience in clinical medicine in an area relevant to the TA
  • 8+ years industry / business experience with a minimum of 3 years experience in a relevant area for this function (e.g. Medical Affairs or Clinical R&D)
  • Experience with early pipeline products an advantage
  • Adaptability and flexibility
  • Customer & Market Insight
8

Worldwide Medical Affairs Director Resume Examples & Samples

  • For the assigned Medical Affairs studies (Phase IIIB-IV, PMS, observational studies without regulatory impact) within program/brand, as a member of the Global Medical Affairs Team (GMAT), provides medical scientific input
  • Serve as a disease area scientific and medical expert for internal customers/stakeholders, e.g., GCT, Scientific Review Committee, research, exploratory development, device development, Marketing, Novartis local medical organizations, and other line functions within GMA&HEOR and external customers e.g., Key Opinion Leaders (KOLs) and patient advocacy groups
  • Build together with the GBMD a highly influential medical and scientifically based platform
  • Provide medical scientific input for the assigned program/brand(s)
  • Support GBMD in ensuring compliance of promotional and non-promotional global material and all Medical Affairs activities
  • Support or deputise GBMD in providing input into brand safety related activities for the assigned program
  • Deputize for the GBMD in Global Clinical Team (GCT), Global Brand Team (GBT), Clinical Scientific Unit (CSU) and internal decision boards as the Medical Affairs spokesperson
  • Contribute to talent and career development of MA and Development colleagues like MCLs, SciOps, CTH, CM through active participation in on-boarding, training and mentoring activities. . See job description for further details
9

Medical Affairs Director Resume Examples & Samples

  • Clinical (patient care) or deep research experience in assigned therapeutic area(s) beyond that obtained in the terminal degree program
  • A minimum of 3 years’ experience and proven therapeutic competence with biosimilars / biologicals; or analogous experience in Merck US Medical Affairs
  • Capable of conducting doctoral level discussions with key customers
  • Business and market knowledge, including quality management
  • Must possess a thorough understanding of the FDA, OIG, HIPAA and other ethical guidelines, laws, and regulations relevant to the pharmaceutical industry
  • Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel)
10

Medical Affairs Director Immunology IBD Resume Examples & Samples

  • Provide input to EMEA business development initiatives for allocated product(s) when requested
  • Able to accommodate substantial travel
  • Sign off on Protocols for pan EMEA
  • Product EMEA MA Publication Strategy
  • Review and approval of product EMEA Medical Education Programs and scientific materials
  • Sign off on EMEA Core Medical Information Responses (CMIRs)
  • Medical review and approval of market research and promotional materials
  • 4 OTHER FEATURES OF THE JOB
  • Excellent knowledge of the TA in general with a good knowledge of all products within TA
  • Scientific or Medical degree and higher medical qualification essential
  • 2+ years experience in clinical medicine in an area relevant to the TA
  • 5 + years industry / business experience with a minimum of 2 years experience in a relevant area for this function (e.g. Medical Affairs or Clinical R&D)
  • Medical expertise in Gastroenterology and especially in IBD is a must have (could be 5+ years working in this area in the pharma or being an academic Gastroenterologist)
  • MD, being a potential ETAL Immunology
  • Product and Therapeutic Area Knowledge and Patient Insight
  • Medical Strategy Development
  • Clinical Activities Strategy, Planning and Design
  • Budgetary Skills and Performance Metrics
  • Networking and Collaborating
  • Communication and Interpersonal Skills
  • Business Tools
11

Asia Pacific Medical Affairs Director, IDV Resume Examples & Samples

  • Provide input to AP business development initiatives for IDV when requested
  • To provide medical scientific and strategic input as requested – e.g. for future cardiometabolic pipeline and/or for established products
  • Development of AP IDV Medical Plan
  • Support IDV product launches
  • In-depth knowledge and hands-on experience of clinical trial design and study data analysis (e.g. statistical analysis) and interpretation
  • Good knowledge of Drug development process, MAF specific activities and GCP requirements
  • Good knowledge of study execution, pharmacovigilance
  • Asia Pacific specificity awareness
  • Launch experience an advantage
  • Therapeutic Area Awareness
  • Organisation and Project Management
  • Product Development ExpertiseMedical Affairs
12

Oncology Medical Affairs Director Resume Examples & Samples

  • Pertinence and quality of scientific recommendations in compliance with current legislation
  • Quality relationship with leaders and researchers
  • Compliance with medico-marketing strategy
  • Compliance with timelines, budget and data reliability
  • M.D
  • Experience in: Medico-Marketing in Onco-haematology, Pharmaceutical industry and /or Research and Development
  • Scientific and medical knowledge
  • Onco-haematology therapeutic area
  • Takeda Products
  • Clinical trials methodology
  • Competitor products
  • Legislation on clinical trials (Public health code, Huriet Law, DMOS, MV certification guidelines, etc.)
  • Health economics (medico-economics, pharmaco-economics)
  • Oral and written communication methods
  • Management methods
  • General information technology tools
13

Medical Affairs Director Dermatology Resume Examples & Samples

  • Review and approve the content of EMEA Core Medical Information Responses (EMEA CMIRs) once drafted by the SKM (Scientific Knowledge Management) Product Specialists and Virtual Teams
  • Work with designated EMEA SKM (Scientific Knowledge Management Product Specialist (s) to integrate and align Medical Information requirements with the EMEA MA Strategy and Plan
  • Act as expert resource, providing input to responses to complex medical information enquiries
  • 2 SPECIAL REQUIREMENTS
  • Fluency in English language required
  • Fluency in additional EMEA languages an advantage
  • 3 ACOUNTABILITIES
  • EMEA Medical Affairs Strategy and Plan
  • Line Management of Medical Advisors
  • Product budget for pan-EMEA MAF activities
  • Study Specific Summaries of pan-EMEA studies for Annual Safety Reports
  • Review and approve single country interventional protocols
  • Final Study Report for EMEA MA Studies
  • 1 ESSENTIAL KNOWLEDGE & SKILLS
  • In-depth knowledge with at least one product within Dermatology Immunology TA including main competitors
  • Excellent knowledge of the Dermatology Immunology TA in general with a good knowledge of all products within TA
  • Good knowledge of EU CTD and GCP requirements
  • Sound knowledge of study publication processes and publications within the TA
  • Highly customer and market place focused with an awareness of the importance of business results
  • Very strong and demonstrable communication and influencing skills that can impact at a Regional and Global level
  • Candidate must have a profile that enables to be considered as a strong potential of becoming ETAL in Immunology (Strong business acumen and leadership skills)
  • 2 EXPERIENCE
  • 2+ years’ experience in clinical medicine in an area relevant to the TA
  • 5 + years industry / business experience with a minimum of 2 years’ experience in a relevant area for this function (e.g. Medical Affairs or Clinical R&D)
  • 1 – 3 years project management, team leader or functional line management experience
  • Industry and Marketplace
  • Organisational Awareness
  • Medical WritingMedical Affairs
14

Medical Affairs Director Resume Examples & Samples

  • Lead/Chair product Medical team
  • Co-Chair product brand team with Marketing Brand lead
  • Responsible for the development and implementation of product medical plans
  • Product Drug Safety Review Committee representative for US Phase IV program
  • Manage and oversee product investigator initiated studies program
  • Partner with Global Life Cycle Leader to ensure product Medical initiatives are communicated and approved according to contractual agreements
  • Partner with Regulatory Affairs (Cherry Hill) on product NDA annual reports, label updates and FDA communications
  • Partner with Clinical Science on product clinical development initiatives
  • Function as a medical expert for Actelion products and provide expertise as needed within and outside the organization
  • Build strong relationships with key opinion leaders (KOLs) in the therapeutic area of interest and be committed to continuous scientific exchange with KOLs as appropriate in the field and during medical congresses
  • Act as the Clinical Leader for product Phase IV studies, manage Medical Monitors and ensuring that clinical trials are conducted according to the investigational plan, regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Actelion SOPs
  • Responsible for ensuring study protocols, amendments, specific sections of study manuals and other documents meeting internal and external requirements
  • Responsible for managing data from Phase IV clinical program
  • Responsible for the quality data and scientific presentations, and manuscripts for publication
  • Develop medical strategy for advisory boards and steering committees
  • Responsible for scientific data at scientific conferences and other venues
  • Oversee the development and presentation of scientific data to internal and external audiences
  • Responsible for the content and quality of the clinical study reports for Phase IV and other regulatory documents as needed
  • Responsible for the development of the medical plans and timely execution of the plans, both strategic and tactical
  • Partner and serve as the Medical Lead for necessary cross-functional teams within Actelion US and Global
  • Collaborate and communicate effectively with Global Medical Affairs and Global Clinical Operations and other relevant teams in relation to assigned responsibilities and programs
15

Medical Affairs Director Resume Examples & Samples

  • Minimum of three (3) years experience and proven therapeutic competence in the Disease area
  • Clinical (patient care) or Deep Research experience in assigned therapeutic area(s) beyond that obtained in the terminal degree program
  • Thorough understanding of the FDA, OIG, HIPPA and other ethical guidelines relevant to the Pharmaceutical Industry
  • Excellent interpersonal, communication and networking skills
  • Must be able to organize, prioritize and work effectively in a constantly changing environment
  • Strong working knowledge of Microsoft Office Suite (Word, PowerPoint, Excel, Access)
  • Willing and able to travel: 40-60%
16

Regional Medical Affairs Director Resume Examples & Samples

  • To provide leadership and technical support to the incumbent’s local / regional Medical and Scientific Affairs team whilst also leading, developing and maintaining the global Medical and Scientific Affairs function
  • The role is key not only in maintaining the day to day ethical, safety and regulatory aspects of a healthcare business, but also in defending and further developing the healthcare categories and co-ordinating efforts globally and locally to influence change and maximise the opportunities for the business
  • Drive close collaboration with the R&D, marketing and Regulatory groups to support the local / regional business
  • The ability to manage a local team whilst focussing on global strategy
  • An ability to support existing local / regional brands whilst guiding global best practice and seeking out new opportunities for RB
  • International understanding and flexibility to travel / work across time zones
  • Experience of guiding teams, managing in a matrix and working with ambiguity
  • Experience of building and developing high-performing teams and functions
  • Experience of working with and influencing governmental departments, KOLs and decision makers on an international level within healthcare
  • A medical degree with broad medical and pharmaceutical / consumer health industry knowledge and experience is preferred
  • Life science qualifications will be considered when supported by appropriate experience
  • Knowledge of healthcare regulations, promotional affairs and pharmacovigilance
  • Broad knowledge of international regulatory frameworks as they relate to medical and clinical requirements for product registration and research
  • Experience in the Consumer Healthcare sector
  • Experience of working closely with commercial colleagues and strong understanding of corporate and operational business issues
17

Regional Medical Affairs Director Resume Examples & Samples

  • To provide Medical Affairs leadership to the incumbent’s local and regional Medical and Scientific Affairs team globally
  • Member of the Global Medical Affairs and Clinical Leadership Team
  • Drive close collaboration with the wider R&D teams, including Global Medical Affairs, Clinical Research, Regulatory, Safety, Quality, Compliance teams and other key stakeholders to support the local / regional business strategies
  • The ability to manage local teams, magnifying and execute global strategies
  • Experience of people management, talent development and offering clear strategic guidance
  • Experience of building teams, managing in a matrix and working at an international level within healthcare
  • Knowledge of healthcare practices and regulations
18

Medical Affairs Director NAF Resume Examples & Samples

  • Lead the Medical Affairs team
  • Member of the NAF Management team
  • Develops together with team
  • Medical Strategy
  • Medical Education Plans
  • KOL Developments Plans
  • MSL activities plans
  • Data generation and dissemination plan
  • Local publication plan
  • MAF projects
  • Manages MAF budget
  • Monitors actively MAF performance
  • Ensures compliance
  • Collaborates actively with different functions
  • Education: Medical doctor / Pharmacist
  • Years of Experience: min 10 years relevant experience
  • Language: English and preferably Arabic
  • Location: Cairo, Egypt
  • Relocation availability
  • SHAPE: Drive innovation; anticipate and shape industry and market changes to advance health care globally
  • DELIVER: Deliver results by inspiring and mobilizing people and teams
  • Experienced leader
  • Excellent collaboration skills
  • People management experience
  • Pragmatic and solutions oriented
  • Proven people development capabilities
  • Modern leadership style (less hierarchical)1700158126W
19

Medical Affairs Director, &I Resume Examples & Samples

  • Act as full partner to cross functional brand team for brand planning and brand leadership
  • Ensure execution of agreed medical affairs plan, by direct activities and by leadership of the I&I Medical Affairs team
  • Manage and ensure appropriate team execution and development, including supervising and providing a medical insight to all training programs, working to agree executional plan and ensuring a proper follow-up
  • Identify, develop and maintain collaborative relationships with current and future key thought leaders and healthcare stakeholders in disease states of strategic importance to Celgene
  • Provide regional perspective and imperatives on KOL/stakeholder development
  • Act as key interface to thought leaders (or external partners) in order to disseminate clinical information, medical education opportunities/materials, and facilitate scientific exchange
  • Provides medical input to the strategy, planning and review of clinical publications, and review of external clinical research proposals involving the Company products
  • Evaluate and profile potential investigators/sites to participate in clinical development studies and/or other opportunities for research collaborations utilising Celgene’s pipeline compounds
  • Assist in the reconnaissance of Market landscape determination and competitive intelligence including therapeutic trends and unmet needs within the appropriate disease states and marketplace
  • Work cross functionally to help develop appropriate/pertinent tactical activities and resource materials to be distributed upon request to physicians in targeted disease areas
  • Maintain scientific expertise in Therapeutic Area concordant with current knowledge and practice
  • Supports general clinical and medical affairs activities involving product evaluation and implementation of franchise business strategies opportunities
  • Assists in identifying new marketing opportunities
  • Supports the development of training programs for RML and Commercial colleagues, as appropriate
  • Participate actively to cross functional teams to conduct global projects
  • Lead all activities within Spain Compliance requirements. Have the ability to respond to any adverse queries, events or complaints
  • Responsibility for ensuring I&I medical operations work within our agreed compliance framework and SOPs with final signatory responsibility for the code of practice
  • Liaise and work closely with the Drug Safety Team who have the key responsibility to report and manage adverse events and risk management
  • Responsibility for contributing medical / clinical component of HTA submissions and front facing reimbursement and other agencies on medical / clinical matters as appropriate
20

Medical Affairs Director Resume Examples & Samples

  • Sales – Travel with the field sales force as needed (primarily in the US, but also abroad) to meet with doctors to present both clinical and economic evidence
  • Marketing – Understand developments in their assigned specialty and use this knowledge to partner with the marketing team in regards to current and future portfolio decisions
  • Medical Conferences - Represent SI at national and international meetings by participating in clinical discussions, managing symposia, and fostering education and adoption efforts in the exhibit hall
  • Medical Science - Master the relevant literature regarding disease pathophysiology, diagnosis and management across their assigned specialty
  • Advisory Boards - Own and operate clinical advisory boards to ensure the availability of highly qualified, knowledgeable subject matter experts in support of specific business objectives
  • Scientific Communications – Work closely with the scientific communications teams to develop protocols and publication plans as well as package published evidence in a format that is useful for the sales force - provide medical review for both promotional and non-promotional materials
  • Clinical Education - Collaborate with the Professional Affairs and Clinical Education team to ensure effective and compliant physician education programs
  • Strategy – Further develop specialty-specific long term strategy to enable portfolio and call point expansion
  • Clinical Research - Advise the clinical research team in creating safe, relevant and clinically valuable pre and post market trials and registries
  • R&D/Pre-Clinical Affairs – Participate in the identification and testing of new devices and materials, which requires a strong scientific orientation
  • Business Development & Licensing – Identify acquisition and licensing partnerships as well as participate as a member of the due diligence teams
  • Regulatory Affairs – Understand the complexities of the regulatory approval process, eg be well-versed in the requirements of the European Medical Device Directive and US FDA PMA and 510(k) processes
  • Quality Affairs/Safety – Have intimate knowledge of quality and safety issues specific to the portfolio
  • Legal - Serve as a consultant to the legal team to provide clinical information of importance for product liability and intellectual property cases
21

Worldwide Medical Affairs Director Resume Examples & Samples

  • For the assigned Medical Affairs studies (Phase IIIB-IV, PMS, non-interventional studies without regulatory impact) within program/brand, as a member of the Global Medical Affairs Team (GMAT), the Global Medical Affairs Director provides medical scientific input to, e.g.: a. Key activities related to planning, execution and reporting of Global Medical Affairs studies and ensure timely and on budget delivery. b. Develop or contribute to study-related documents (e.g. concept sheets, protocols, case report forms, statistical plan, data analysis plan, study reports, publications). c. Develop/contribute and review presentation materials for study/program-related advisory boards, investigator meetings, protocol training meetings for Novartis local medical organizations and external speaker at meetings when required. d. On-going review of clinical study data, final analysis and interpretation, in collaboration with the Brand Safety Leader, appropriate Global Clinical Team (GCT) members and the GBT (Global Brand Team). e. Act as medical key contact point for assigned Medical Affairs studies
  • Serve as a disease area scientific and medical expert for internal customers/stakeholders, e.g., Global Clinical Team, Scientific Review Committee, research, exploratory development, device development, Marketing, Novartis Country Pharma Organizations (CPOs), and other line functions within Global Medical Affairs and external customers e.g., Health Care Professionals (HCPs) ,Market Access and Patient Advocacy Groups (PAGs)
  • Build together with the GBMD Medical Affairs strategy
22

Worldwide Medical Affairs Director Neuroscience Resume Examples & Samples

  • For the assigned Medical Affairs studies (Phase IIIB-IV, Post Marketing Surveillance, non-interventional studies without regulatory impact) within program/brand, as a member of the Global Medical Affairs Team (GMAT), the Global Medical Affairs Director provides medical scientific input to, e.g
  • Proven ability to interpret, discuss and represent efficacy, statistical and safety data relating to the assigned area
  • Demonstrated ability to establish strong scientific partnership with key investigators in assigned Therapeutic Area
  • Medical and/or scientific expertise within a disease area required
23

Category Medical Affairs Director Resume Examples & Samples

  • Min. 4 years experience in the Pharmaceutical or Healthcare industry, preferably in a Pharmaceutical/ Consumer Healthcare / FMCH Business with experience in Medical &/or Scientific Affairs
  • Demonstrated experience and proven track record working as part of a Medical Affairs team within larger complex matrix organization
  • Demonstrated experience representing an Organization with external stakeholders
  • Clinical and / or academic research background preferred
  • Specific Category experience for the aligned Consumer Category E.G. Respiratory
  • Project specific commercial support – claims support including the creation and approval of Claims Support Summary (CSS) documents and coordinating review / approval of promotional activities
  • Development and implementation of scientific engagement activities
  • Contributor to the category/ sub-category medical team meetings
  • Supporting GSK through engagement with external organizations including Health Authorities, Healthcare Organizations, External Experts etc
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Worldwide Medical Affairs Director Resume Examples & Samples

  • Build together with the Global Brand Medical Director Medical Affairs strategy
  • Advanced medical/scientific writing and communication skills
  • Proven ability to work both independently and in a cross functional team setting, including a highly-matrixed environment