Global Development Lead – Internal Medicine, Clinical Strategy

Pfizer; Elkview (WV); Hybrid; USD 275,000 - 458,000; Full time

Benefits offered by this job

401(k) with Pfizer Matching Contrib.

Pfizer Retirement Savings Contribution

Paid vacation/holiday/personal days

Health benefits

Job summary

Pfizer seeks a Global Development Lead (GDL) to be the single clinical point of accountability for development of assigned assets within Internal Medicine. You will lead a cross-functional team across clinical, pharmacology, statistics and safety to design, execute and interpret studies for worldwide regulatory submissions.

The GDL creates and endorses the Clinical Development Plan, partners with trial clinicians on governance and strategy, and drives submission deliverables (SCE, SCS).

Qualifications

• Endocrinologist or internal medicine physician with cardiometabolic late-stage development experience including type 2 diabetes experience.
• 8+ years of relevant experience in clinical research and development in academia or biopharma.
• Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management.
• Demonstrated leadership and ability to manage large teams in clinical development.

Responsibilities

• Lead the cross-functional Clinical Development Team across design, execution and interpretation of studies for worldwide regulatory submissions.
• Create and gain endorsement for the Clinical Development Plan and associated protocol designs.
• Provide input for target product profiles and regulatory activities including labels and Investigator Brochures.
• Engage external stakeholders (Ad boards, Steering Committees, DMC) to drive strategic insights for development strategy.

Skills

Clinical development strategy

Cross-functional leadership

Regulatory submissions

ICH/GCP knowledge

Leadership

Communication

Trial design

Data interpretation

Education

MD or DO

Job description

Pfizer seeks a Global Development Lead (GDL) to be the single clinical point of accountability for development of assigned assets within Internal Medicine. You will lead a cross-functional team across clinical, pharmacology, statistics and safety to design, execute and interpret studies for worldwide regulatory submissions.

The GDL creates and endorses the Clinical Development Plan, partners with trial clinicians on governance and strategy, and drives submission deliverables (SCE, SCS).