- Reporting to the VP/Global Development Lead, the Global Clinical Development Lead (GCDL) will serve a key role of providing expert medical input to one or more clinical development programs.
- 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.
- Will act as a company representative interacting with external scientific leaders and Regulatory authorities.
- 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.
- 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.
- Co-lead product safety review committees (SRT) as appropriate
- Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions
- 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).
- 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 therapeutic area knowledge and ensures consistent best practices across all activities
Education and Experience requirements
- 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
A moderate amount of domestic and/or international travel (25%) may be required
Strong interpersonal skills, ability to work in a fast paced matrix environment