Global Development Lead, Internal Medicine (MD, Sr. Director)

About the role

The Global Development Lead (GDL) represents Clinical on the Global Medicine Team and is the single clinical point of accountability for clinical development for assigned asset(s) in Internal Medicine, Research & Development, Pfizer. The individual will lead the cross-functional Clinical Development Team including but not limited to clinical, clinical pharmacology, statistics, safety, commercial, patient access, and operations colleagues in the design, execution and interpretation of studies in support of worldwide regulatory submissions.

Responsibilities

• Partners effectively with the Medicine Team Lead to negotiate tradeoffs, milestones and ensure delivery of the clinical program in line with agreed timelines and budget.
• Responsible for comprehensive clinical development plan to secure approval and reimbursement globally (including China and Japan) along with creating the pediatric investigation plan / pediatric study plan and associated protocol design documents working closely with individual trial clinicians to ensure trial feasibility and optimized operational execution.
• Provides product/program specific input for target product profile(s).
• Willingness to bring innovative thinking and bold decision making across clinical development programs and individual studies.
• Develops specific clinical development enabling strategies including digital/innovation and patient engagement approaches.
• Pairs with Trial clinicians on governance reviews (incl Sci/Ops) for assigned clinical studies.
• Provides category clinical development strategy input and insights to trial clinicians for assigned clinical studies.
• Provides therapy area/indication expertise in support of clinical review of clinical data – including CRF design, assistance in signal interpretation, contextualizing adverse events as required.
• Provides specialized medical monitoring support for individual trial team, if required.
• Key partner in trial-level statistical analysis plan, table-listings-figures, database release in partnership with statistics and programming.
• Develops submission level deliverables (IAP, IARP and submission TLFs).
• Responsible for submission deliverables including SCE and SCS.
• Supports appropriate interpretation and communication of clinical trial data.
• Reviews and approves submission level safety narrative plan.
• Supports product label development and maintenance.
• Engages key external stakeholders e.g., Ad boards, Steering Committees, DMC, Adjudication Committees, patients and patient advocates and other external stakeholders, to drive strategic insight generation to support clinical development strategy and PDD development.
• Provides regulatory submission support (DSUR, PBRER) submission disclosure deliverables and product defense.
• Ensures compliance with internal SOPs and external regulatory standards.
• Reviews IIR proposals.

Qualifications

• Education: MD or DO
• Experience: Cardiologist (strongly preferred) with cardiovascular outcome trials or large complex, global development programs. 8+ years of relevant experience and track record of success in academia and/or the biopharmaceutical industry in clinical research and development.
• Knowledge: Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management.
• Skills: Demonstrated clinical/medical, administrative, and project management capabilities, as well as effective verbal and written communication skills in relating to individuals both inside and outside Pfizer. Demonstrated experience managing and training large teams in clinical development. Demonstrated experience in designing and launching large teams preferred.