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

Role Summary

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—to design, execute, and interpret studies in support of worldwide regulatory submissions, and to develop and secure endorsement for the Clinical Development Plan and associated protocol design documents.

• Partners effectively with the Medicine Team Lead to negotiate trade‑offs, milestones, and ensure delivery of the clinical program in line with agreed timelines and budget.
• Develops and implements a comprehensive clinical development plan to secure approval and reimbursement globally (including China and Japan), and creates the pediatric investigation plan / pediatric study plan and associated protocol design documents.
• Provides product/program specific input for the target product profile(s) and clinical data review, including CRF design, signal interpretation, and contextualization of adverse events.
• Brings 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.
• Partners with trial clinicians on governance reviews for assigned clinical studies and provides category‑level clinical development strategy input.
• Provides specialized medical monitoring support for individual trial teams, if required.
• Key partner in trial‑level statistical analysis plan, table‑listings‑figures, and database release in partnership with statistics and programming.
• Develops submission‑level deliverables (IAP, IARP, submission TLFs) and is responsible for submission deliverables including SCE and SCS.
• Supports appropriate interpretation and communication of clinical trial data and review/approval of submission‑level safety narrative plan.
• Supports product label development and maintenance.
• Engages key external stakeholders—such as Advisory Boards, Steering Committees, Data Monitoring Committees, and patient advocates—to drive strategic insight generation for 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.

MD or DO.

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

• Medical / Scientific credibility/Excellence—track record of achievement in pharmaceutical development and ability to coordinate and execute clinical development or lifecycle strategy.
• Management experience—able to work in a highly complex matrixed environment and influence cross‑functional teams.
• Leadership—persuasive and effective leader of staff.
• Influencing—able to manage and motivate internal teams on clinical trials.
• Conflict Management—mentoring/coaching others to improve conflict management skills and settle disputes equitably.
• Team Building—creates a strong morale and spirit in the team and fosters open dialogue.
• Accountability—takes personal responsibility for results and delivers outcomes.
• Change agility—demonstrates perspective and poise in the…