Global Clinical Development Lead Resume Samples
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Global Clinical Development Lead Resume Samples
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CF
C Fadel
Camille
Fadel
7988 Bradtke Meadows
Los Angeles
CA
+1 (555) 273 7684
7988 Bradtke Meadows
Los Angeles
CA
Phone
p
+1 (555) 273 7684
Experience
Experience
New York, NY
Global Clinical Development Lead
New York, NY
Kuhn-Boehm
New York, NY
Global Clinical Development Lead
- Represent clinical development in due diligences and other assessments of external opportunities
- Significant late-stage development research
- Provide expert medical advice to the project teams for the development of Phase I-IV development programs. Provide medical input into development of the Target Product Profile (TPP)
- Design, author, and implement clinical development plans; contribute to preparation of product and therapeutic area related strategy documents
- Preparation of clinical documents including sections for submission to regulatory authorities (meeting packages, Investigational Drug Applications (IND/CTA), NDAs, clinical components of other regulatory packages)
- Contribute to scientific publications, provide consultation on medical subjects to investigators and other company personnel, establish rapport with site personnel, external authors and key opinion leaders and searching and analyzing medical literature
- Remain up to date with current information on pharmaceutical regulations, guidelines and practices and therapeutic area knowledge
Chicago, IL
Global Clinical Development Lead, Hepatology
Chicago, IL
Reichel, Herzog and Hackett
Chicago, IL
Global Clinical Development Lead, Hepatology
- Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions
- Leads and/or participates in marketing and clinical/medical advisory panels, steering committees and investigator meetings
- Responsible for the benefit/risk clinical assessment, in collaboration with the safety review team (SRT); reports to GDT major safety issues and proposes adaptation accordingly; ensure together with PV leader the delivery of key safety documents (e.g., Risk Management Plan)
- Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities
- Co-chair of the safety review team (SRT)
- Acting as a senior company representative interacting with external scientific leaders and/or Regulatory authorities
- Participates on the Global Medical Team as the GCDL
present
Detroit, MI
Global Clinical Development Lead-dir
Detroit, MI
Runolfsson-Dietrich
present
Detroit, MI
Global Clinical Development Lead-dir
present
- Drives clinical activities of one or more Programs including life cycle management (LCM) and co-leads the development operations team (DOT)
- Provides expert Medical advice / leadership to the project teams for the development of Phase I-IV clinical programs
- Leads development of clinical studies and reviews clinical protocols and clinical study reports for scientific and medical accuracy
- Provides credible company representation in the academic Medical/Scientific Community to facilitate the constructive exchange of positions and ideas
- Participates in drug safety surveillance for Development projects
- Provide primary medical leadership in execution of clinical trials
- Co-Leads the development operations team (DOT)
Education
Education
Bachelor’s Degree in Problem Solving Ability
Bachelor’s Degree in Problem Solving Ability
University of Virginia
Bachelor’s Degree in Problem Solving Ability
Skills
Skills
- Experience in rare diseases highly desired
- Demonstrated in-depth understanding of drug development and pharmaceutical marketing within therapy area
- Working knowledge of regulations relating to drug development and promotional activities
- Demonstrated ability to communicate and plan effectively with other Shire departments and to respond to inquiries or complaints from customers
- Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Shire; ability to build and support teams of diverse background to improve service to present and future customers and to deliver business results
- Strong judgement and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies; demonstrated ability to take a big-picture approach to decision making while taking account of the interests of the entire organization
- Ability to capitalize on business opportunities by developing well thought out strategies and initiatives
- Availability to travel approximately 25% of time
- Availability to participate in early or late meetings/teleconferences
2 Global Clinical Development Lead resume templates
Read our complete resume writing guides
1
Global Clinical Development Lead, Hematology Resume Examples & Samples
- Leads development of clinical studies and reviews clinical protocols and clinical study reports for scientific and medical accuracy
- Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions
- MD required with at least 2 years experience in Clinical Research in the Pharmaceutical or Biotech industries
- Experience conducting phase 2 or 3 studies required
- Experience in Hematology and/or training in Hematology preferred
2
Global Clinical Development Lead, Hepatology Resume Examples & Samples
- Responsible for the benefit/risk clinical assessment, in collaboration with the safety review team (SRT); reports to GDT major safety issues and proposes adaptation accordingly; ensure together with PV leader the delivery of key safety documents (e.g., Risk Management Plan)
- Provide primary medical leadership in execution of clinical trials
- Co-Leads in safety review committees and risk management activities as appropriate
3
Global Clinical Development Lead Resume Examples & Samples
- Lead/participate as needed in investigator meetings, advisory committee, and scientific meetings. Participate/present at regulatory meetings as needed as Clinical Lead
- Responsibilities will include design and supervision of Shire sponsored clinical trials and medical interpretation of data analyses. Review and input into documents (such as protocols, CRFs, Statistical Analysis Plans, CSRs) to ensure scientific and medical accuracy. Responsibilities may include post marketing commitments and life cycle management initiatives
- Preparation of clinical documents including sections for submission to regulatory authorities (meeting packages, Investigational Drug Applications (IND/CTA), NDAs, clinical components of other regulatory packages)
- Remain up to date with current information on pharmaceutical regulations, guidelines and practices and therapeutic area knowledge
- Design, author, and implement clinical development plans; contribute to preparation of product and therapeutic area related strategy documents
- Represent clinical development in due diligences and other assessments of external opportunities
4
Global Clinical Development Lead Resume Examples & Samples
- May supervise a variable number of CD professional and administrative staff; Responsible for the overall direction, coordination and evaluation of the direct reports; Responsibilities include interviewing, hiring and training employees, planning assigning and directing work; appraising performance rewarding and disciplining employees, addressing complaints and resolving problems
- Strong experience in the Pharmaceutical Industry with relevant industry experience
- Significant late-stage development research experience
5
Global Clinical Development Lead, MD Resume Examples & Samples
- Oversight of study design and data generated, including clinical trial medical monitoring, from Shire sponsored Phase I-IV clinical research programs ensuring that regulatory authority requirements, stakeholder requirements, and quality standards are met
- Interacts as needed with CD partners such as CDOB, Regulatory, Commercial, Compliance, and Business Unit management teams
- M.D. degree (required); specialty training and certification in Gastroenterology (preferred)
6
Global Clinical Development Lead-endocrinology Resume Examples & Samples
- Providing leadership and management within CD to provide medical and scientific support for products within assigned therapy area
- This position may be combined with the GCDL position when the program is limited in its scope and complexity
- Interacts as needed with CD partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams
- M.D. degree (required); specialty training and certification in Endocrinology (preferred)
- Generally has at least eight (8) years of experience in the Pharmaceutical Industry with relevant industry experience
7
Global Clinical Development Lead Resume Examples & Samples
- Reporting to the Global Development Team Lead, the Global Clinical Development Lead will serve a key role of providing expert medical input to one or more clinical development programs. In collaboration with the global Clinical Operations lead, (s)he will lead the DOT (Development Operations Team) and coordinate global study activities on the program
- Lead development of the Clinical Strategy/Clinical Development Plan (CDP). Provide medical oversight into protocol development, data generation and reporting from Shire sponsored Phase I-IV clinical development programs ensuring that regulatory requirements and quality standards are met
- Will act as a company representative interacting with external scientific leaders and Regulatory authorities
- Assist with clinical assessment of new business development opportunities as needed
8
Global Clinical Development Lead-gi Resume Examples & Samples
- Leads and/or participates in marketing and clinical/medical advisory panels, steering committees and investigator meetings
- Provides expert Medical advice / leadership to the project teams for the development of Phase I-IV clinical programs
- M.D. degree (required); specialty training and certification in Gastroenterology or Pediatrics (preferred)
- Expertise in Gastroenterology and Pediatrics are preferred
- Experience in rare diseases highly desired
- Demonstrated in-depth understanding of drug development and pharmaceutical marketing within therapy area
- Demonstrated ability to communicate and plan effectively with other Shire departments and to respond to inquiries or complaints from customers
- Strong management skills with demonstrated ability to plan for staffing needs, make hiring decisions, set goals and objectives, establish and recalibrate priorities, provide feedback and appraise work. Ability to regularly assess individuals’ skills, talents and career interests which ensure development of a talent pool for the future. Ability to create and maintain and organizational structure that serves the needs of the business
- Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Shire; ability to build and support teams of diverse background to improve service to present and future customers and to deliver business results
- Strong judgement and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies; demonstrated ability to take a big-picture approach to decision making while taking account of the interests of the entire organization
- Ability to capitalize on business opportunities by developing well thought out strategies and initiatives
9
Global Clinical Development Lead-neuroscience Resume Examples & Samples
- Collaborates with Global Development Team Lead, Therapeutic Area Head, R&D Business Unit Leaders, CDOB, International Medical Director and External Scientific Affairs to ensure that all development and product support activities for the therapeutic area(s) are coordinated and consistent; Provides scientific advice within Shire R&D and other functions (e.g. Business Unit Strategy Teams, Commercial Brand Teams) leveraging scientific expertise and providing guidance in support of brands and product launches
- May supervises a variable number of CD professional and administrative staff; Responsible for the overall direction, coordination and evaluation of the direct reports; Responsibilities include interviewing, hiring and training employees, planning assigning and directing work; appraising performance rewarding and disciplining employees, addressing complaints and resolving problems. Can manage Junior-level Physicians
- M.D. degree (required); specialty training and certification in Neurology or Psychiatry (preferred)
- Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities, and /or
10
Global Clinical Development Lead-dir Resume Examples & Samples
- Drives clinical activities of one or more Programs including life cycle management (LCM) and co-leads the development operations team (DOT)
- In collaboration with the DOT, defines clinical strategy (clinical development plan, CDP) which is aligned with the Program strategy as defined by the global development team (GDT)
- Participates on the Global Medical Team as the GCDL
- Co-chair of the safety review team (SRT)
- Co-Leads the development operations team (DOT)
- Assures conduct of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles
11
Global Clinical Development Lead, Neurology Resume Examples & Samples
- Lead a team of physicians working on an experimental early stage clinical program
- Lead a clinical program team and support the eventual worldwide commercialization of these agents
- Provide strategic leadership for the clinical programs that integrates both the individual’s extensive knowledge in the disease area and the medical and advocacy community around that world and the commercial, research, regulatory, and medical research goals and needs of the corporate activities in the disease area
- Oversee development of clinical activities across several drug development studies within a therapeutic area in collaboration with the clinical development teams
- Establish appropriately aggressive clinical development timelines, incorporating key decision points and Go/No Go criteria for each CDP
- Lead strategic initiatives and clinical program team(s), including Clinical Program Leaders (CPLs) and / or Clinical Scientists and Clinical Trial Managers (CTMs)
- Manage clinical program budget(s) within stated financial goals
- Develop and maintain relationships with program counterparts in Global Clinical Operations (GCO), Commercial, Research, Regulatory, and Medical Affairs
- MD degree
- Three (3) to five (5) years of progressive experience in drug development recommended
- Proven track record for clinical and scientific leadership of drug development programs
12
Global Clinical Development Lead-hereditary Angioedema Resume Examples & Samples
- Acting as a senior company representative interacting with external scientific leaders and/or Regulatory authorities
- Assists Business Development with assessments and intelligence on potential new products and assists with due diligence activities as required
- Experience in designing and conducting Phase 1-3 clinical trials; and/or
- Therapeutic expertise ( immunology, allergy) preferred
- Demonstrated in-depth understanding of drug development and pharmaceutical marketing within
13
Global Clinical Development Lead Resume Examples & Samples
- Support clinical strategy (CDP) for assigned products
- Assists the TA leadership with assessments and intelligence on potential new products and due diligence activities
- Oversight of study design and data generated from Shire sponsored Phase I-IV clinical research programs ensuring that regulatory authority requirements, stakeholder requirements, and quality standards are met
- Acting as a company representative interacting with external scientific leaders and/or Regulatory authorities
- Assists Business Development with assessments and intelligence on potential new products and assists with due diligence activities
- Oversees clinical studies and reviews clinical protocols and clinical study reports for scientific and medical accuracy
- Interacts as needed with Clinical Development partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams
- Leads and/or participates in clinical/medical advisory panels, steering committees and investigator meetings
- Assists in providing medical information support for marketed and developmental projects
- Supports Therapy Area Business Unit and Commercial Teams in crafting target product profiles
- Provides input to global publication strategy for the projects/products assuring the highest standards of science, within product strategic needs and Compliance requirements. May work with academic investigators to present and publish clinical trial results at scientific meetings and in peer reviewed medical journals
- Specified therapeutic area experience preferred
14
Global Clinical Development Lead-combination Products Resume Examples & Samples
- Provide medical device expertise on assigned projects including device strategy support as directed by the Head of Medical Devices
- Support Device Safety Assessments on clinical programs
- Ensuring that regulatory authority requirements, stakeholder requirements, and quality standards are met
- Partner with other Shire functions to communicate scientifically accurate information to external stakeholders
- Review clinical protocols and clinical study reports ensuring device related scientific and medical accuracy
- Demonstrates expertise in and support device data review and interpretation to deliver meaningful efficacy and safety conclusions
- Demonstrates the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders
- Provides expert device development advice to assist the project teams for the development of clinical programs
- Interacts as needed with Clinical Development partners such as Clinical Operations, Regulatory, Commercial and Compliance
- Participate in clinical/medical advisory panels, steering committees and investigator meetings
- Participates in safety review committees and risk management activities as appropriate
- Participates in drug safety surveillance for Development projects
- Provides support to publication strategy for assigned projects/products assuring the highest standards of science, within product strategic needs and Compliance requirements
- Remains up to date with current information on device regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities
15
Global Clinical Development Lead-oncology Resume Examples & Samples
- Provide expert medical advice to the project teams for the development of Phase I-IV development programs. Provide medical input into development of the Target Product Profile (TPP)
- Lead/participate in as needed in investigator meetings, advisory committee meetings. Participate/present at Regulatory meetings as needed as Clinical Lead
- Co-lead product safety review committees (SRT) as appropriate
- Preparation of clinical documents, sections or contribute to sections for submission to regulatory authorities (meeting packages, Investigational Drug Applications (IND/CTA), NDAs, clinical components of other regulatory packages)
- Contribute to scientific publications, provide consultation on medical subjects to investigators and other company personnel, establish rapport with site personnel, external authors and key opinion leaders and searching and analyzing medical literature
- MD required with at least 6 years experience in Clinical Research in the pharmaceutical or Biotech industries
16
Global Clinical Development Lead-gastroenterology Resume Examples & Samples
- Support development and execution of medical & clinical strategy for assigned Shire product(s)
- Co-chair of the safety review team for assigned products
- Collaborates with Global Development Team Lead, Therapeutic Area Head, Business Unit Leaders, Clinical Operations, and Global Medical Affairs to ensure that all development and product support activities for the therapeutic area(s) are coordinated and consistent; Provides scientific advice within Shire R&D and other functions (e.g. Business Unit Strategy Teams, Commercial Brand Teams) leveraging scientific expertise and providing guidance in support of brands and product launches
- Assures conduction of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles
- May supervises a variable number of CD professional and administrative staff;; Responsible for the overall direction, coordination and evaluation of the direct reports; Responsibilities include interviewing, hiring and training employees, planning assigning and directing work; appraising performance rewarding and disciplining employees, addressing complaints and resolving problems. Can manage Junior-level Physicians
- Demonstrate the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders
- M.D. degree or PhD required; specialty training in Gastroenterology preferred
- Experience working in Gastroenterology is highly preferred with clinical trial experience in Inflammatory Bowel Disease
- Demonstrated ability to collaborate in a matrixed environment
- Experience in submissions of IND/CTX/NDA/BLA/MAA and interactions with Regulatory authorities, and /or
17
Global Clinical Development Lead-hematology Resume Examples & Samples
- M.D. degree (required); Hematology training and certification (preferred)
- Experience working in rare diseases is highly preferred
- Experience in Submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities, and /or experience in designing and conducting Phase II-III clinical trials; and/or significant late-stage development research
- Therapeutic expertise (Hematology) preferred
- Working knowledge of regulations relating to drug development and promotional activities
- Demonstrated ability to effectively present information to senior management, employees at all levels of the organization, and external audiences. Ability to act as company spokesperson or scientific witness as needed
- Strong business acumen preferred with the ability to shape corporate strategy using knowledge of the global pharmaceutical industry
- Requires ability to resolve interpersonal issues and motivate individuals and teams towards achieving results. Requires ability to critically assess processes, identify opportunities and implement improvements while collaborating with other functional experts. Requires high degree of problem solving ability; understanding of objectives and processes across multiple organizational functions
- Availability to travel approximately 25% of time
- Availability to participate in early or late meetings/teleconferences
18
Global Clinical Development Lead Resume Examples & Samples
- Provide medical input into development of the Target Product Profile (TPP)
- M.D. or D.O. required, Oncology experience required
- Strong collaborative interpersonal and communication skills, ability to problem solve and work in a fast paced environment
19
Global Clinical Development Lead Resume Examples & Samples
- Provide primary clinical development leadership in execution of clinical trials
- May supervises a variable number of CD professional and administrative staff. Responsible for the overall direction, coordination and evaluation of the direct reports; Responsibilities include interviewing, hiring and training employees, planning assigning and directing work; appraising performance rewarding and disciplining employees, addressing complaints and resolving problems
- Provides expert Clinical Development advice / leadership to the project teams for the development of Phase I-IV clinical programs
- Leads development of clinical studies and reviews clinical protocols and clinical study reports for scientific accuracy
- Doctorate degree (MD or PhD)
- M.D. degree (preferred)
20
Global Clinical Development Lead-combination Products Resume Examples & Samples
- Provide medical device expertise on assigned projects including strategy support as directed by the Head of Medical Devices
- Support safety assessments on combination product clinical programs
- Review clinical protocols and clinical study reports ensuring accuracy of scientific and medical information
- Support reviews and interpretation of clinical data to deliver meaningful efficacy and safety conclusions
- Participates in drug safety surveillance for development projects
21
Global Clinical Development Lead Resume Examples & Samples
- Partner with other Shire functions as required to communicate scientifically accurate information to external stakeholders, meeting appropriate legal and regulatory requirements
- May act as a senior company representative interacting with external scientific leaders and/or Regulatory authorities
- Contributes to safety review team for assigned products
- Provides support to publication strategy for the projects/products assuring the highest standards of science, within product strategic needs and Compliance requirements. May work with academic investigators to present and publish clinical trial results at scientific meetings and in peer reviewed medical journals
- Leads development of clinical studies and reviews, contributes to clinical protocols and clinical study reports for scientific and medical accuracy
22
Global Clinical Development Lead Hematologic Malignancies Resume Examples & Samples
- Responsibilities will include design and supervision of Shire sponsored clinical trials, participation in medical interpretation of data analyses. Review and input into documents (such as protocols, CRFs, Statistical Analysis Plans, CSRs) to ensure scientific and medical accuracy. Responsibilities may include post marketing commitments and life cycle management initiatives
- MD required with at least 6 years of experience in Clinical Research in the pharmaceutical or Biotech industries
- Prior experience with interacting with representatives of the FDA and other regulatory agencies is required
23
Global Clinical Development Lead Resume Examples & Samples
- Primary medical monitoring responsibility for clinical study(ies)
- Minimum 3 years’ experience in Clinical Development in Biotech/Pharamceutical industy
- Neonatology, Pediatric Pulmonology, or General Pediatrics experience preferred
24
Global Clinical Development Lead-oncology Resume Examples & Samples
- Provide expert medical advice to the project teams for the development of Phase I-IV development programs
- Responsibilities will include design and supervision of Shire sponsored clinical trials, participation in medical interpretation of data analyses, safety reviews
- Review and input into documents (such as protocols, CRFs, Statistical Analysis Plans, CSRs) to ensure scientific and medical accuracy. Responsibilities may include post marketing commitments and life cycle management initiatives
- Specialty training with a minimum 5 years’ experience working in Clinical Development in the Biotech or Pharmaceutical industry
25
Global Clinical Development Lead Resume Examples & Samples
- The GCDL will be a member of the strategic Late Product Team (LPT) for the assigned clinical development program(s), and in addition will serve as chair of the LPT’s Clinical Sub-Team
- In collaboration with the global Clinical Operations lead, (s)he will lead the DOT (Development Operations Team) and coordinate global study activities on the program
- Will lead development of the Clinical Strategy/Clinical Development Plan (CDP). Provide medical oversight into protocol development, data generation and reporting from Shire sponsored Phase I-IV clinical development programs ensuring that regulatory requirements and quality standards are met
- Responsibilities will include leading design and supervision of Shire sponsored clinical trials as well as leading medical interpretation of data analyses. Strategic review and input into documents (such as protocols, CRFs, Statistical Analysis Plans, CSRs) to ensure scientific, medical accuracy and consistency with CDP. Responsibilities may include post marketing commitments and life cycle management initiatives
- Lead role in preparation of clinical documents, sections or contribute to sections for submission to regulatory authorities (meeting packages, Investigational Drug Applications (IND/CTA), NDAs, clinical components of other regulatory packages)
- Remain up to date with current information on pharmaceutical regulations, guidelines and therapeutic area knowledge and ensures consistent best practices across all activities
- M.D. degree required with a minimum of 5 years’ experience designing/ conducting phase 2b (or later) human registrational trials in the pharmaceutical or Biotech industries
- Prior experience interacting with representatives of the FDA and other international regulatory agencies is required
- Sub-specialty postgraduate medical training strongly preferred. Preferred specialties include Infectious Diseases, Hematology-Oncology or Nephrology
- Experience in developing transplant drugs and/or board certification in subspecialty is a plus
26
Global Clinical Development Lead Resume Examples & Samples
- Serve a key role of providing expert medical input to one or more global clinical development programs
- Oversees large global clinical studies and reviews clinical protocols and clinical study reports for scientific and medical accuracy
- Minimum 5 years’ experience in Clinical Development in Biotech/Pharamceutical industy
- Experience in submissions of IND/NDA/MAA and interactions with Regulatory authorities, and /or
- Experience in designing and conducting Phase II-III clinical trials
