Global Development Lead, Internal Medicine; Sr. Director

Global Development Lead, Internal Medicine (Sr. Director)

• United States - Washington – Bothell
• United States - New York - Pearl River
• United States - New York - New York City
• United States - Pennsylvania - Collegeville
• United States - Massachusetts - Cambridge

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life‑changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

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.

The GDL is a key partner for other clinical and clinical operations colleagues through the lifecycle of all studies for the assigned asset(s) and may also act as a key partner to external companies in support of Pfizer’s Partner of Choice model. The individual is expected to be an internal subject‑matter expert in their therapeutic area and in clinical drug development.

They may assume responsibility for other clinical leadership opportunities in support of the Obesity portfolio, including trial design, execution and reporting of clinical trials for other late‑stage assets.

• Partner effectively with the Prod Team Lead to negotiate tradeoffs, milestones and ensure delivery of the clinical program in line with agreed timelines and budget.
• Responsible for a 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.
• Provide product/program-specific input for target product profile(s).
• Bring innovative thinking and bold decision‑making across clinical development programs and individual studies.
• Develop specific clinical development enabling strategies including digital/innovation and patient engagement approaches.
• Partner with Trial clinicians on governance reviews (incl. Sci/Ops) for assigned clinical studies, providing category clinical development strategy input and insights.
• Provide therapy area/indication expertise in support of clinical review of clinical data—including CRF design, assistance in signal interpretation, contextualizing adverse events as required.
• Provide 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.
• Develop submission‑level deliverables (IAP, IARP and submission TLFs); responsible for submission deliverables including SCE and SCS.
• Support appropriate interpretation and communication of clinical trial data.
• Review and approve submission-level safety narrative plan.
• Support product label development and maintenance.
• Engage key external stakeholders—e.g., Ad boards, Steering Committees, DMC, Adjudication Committees, patients and patient advocates—to drive strategic insight generation supporting clinical development strategy and PDD development.
• Provide regulatory submission support (DSUR, PBRER), submission disclosure deliverables and product defense.
• Ensure compliance with internal SOPs and…