Global Development Lead, Internal Medicine; MD, Sr. Director

Global Development Lead, Internal Medicine (MD, 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 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 individual will be accountable for creating and gaining endorsement for the Clinical Development Plan and associated protocol design documents. The GDL is a key partner for other clinical and clinical operations colleagues throughout the lifecycle of all studies for the assigned asset(s), and may also partner with 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.

• Partner effectively with the Medicine Team Lead to negotiate tradeoffs, milestones and ensure delivery of the clinical program in line with agreed timelines and budget.
• Lead the cross‑functional Clinical Development Team—including clinical, clinical pharmacology, statistics, safety, commercial, patient access, and operations colleagues—in the design, execution and interpretation of studies supporting worldwide regulatory submissions.
• Be accountable for creating and obtaining endorsement for the Clinical Development Plan and associated protocol design documents.
• Serve as a key partner for other clinical and clinical operations colleagues throughout the lifecycle of all studies for the assigned asset(s).
• Provide specialized monitoring support when required.
• Lead efforts on regulatory submissions and contribute to submission deliverables including the SCE, SCS and clinical overview.
• Provide input for target product profile(s) and support regulatory activities including product labels, core data sheets, Investigator Brochures, Development Safety Update Reports, and Periodic Benefit‑Risk Evaluation Reports.
• Develop comprehensive clinical development plans to secure approval and reimbursement globally (including China and Japan) and create pediatric investigation plans and study plans.
• Provide product/program specific input for target product profiles.
• Bring innovative thinking and bold decision‑making across clinical development programs and individual studies.
• Develop and implement specific clinical development enabling strategies, including digital/innovation and patient engagement approaches.
• Partner with trial clinicians on governance reviews (incl. Sci/Ops) and provide clinical development strategy input and insights.
• Provide therapy‑area/indication expertise in support of clinical data review—including CRF design, signal interpretation, and contextualizing adverse events.
• Act as a key partner in trial‑level statistical analysis plan, table‑listings‑figures, and database release in partnership with statistics and programming.
• Develop submission‑level deliverables (IAP, IARP and submission TLFs) and be responsible for submission deliverables including SCE and SCS.
• Support…