Global Clinical Development Lead for Cardiometabolic Programs

Socket.dev; New York, Town of Florida (NY, NY); Hybrid; USD 215,000 - 358,000; Full time

Job summary

Pfizer is seeking a Global Development Lead (GDL) in a hybrid role, accountable for clinical development across assets in internal medicine. The GDL will lead cross-functional teams in design, execution and interpretation of studies for worldwide regulatory submissions, and oversee development plans, target product profiles, and regulatory activities.

The role involves contributing to pediatric development plans, interacting with trial clinicians, external partners, and external stakeholders to

Qualifications

• BS with 12 yrs or PhD with 7 yrs in clinical/industry experience.
• Experience leading cardiometabolic late-stage development programs, including type 2 diabetes.
• Extensive knowledge of clinical development, global/regulatory regulations, ICH/GCP, adverse event management.

Responsibilities

• Partners effectively with the Prod Team Lead to negotiate milestones and ensure delivery of the clinical program.
• Responsible for comprehensive clinical development plan to secure approval and reimbursement globally.
• Provides product/program specific input for target product profile(s) and regulatory activities.
• Leads submission deliverables including SCE, SCS and clinical overview.
• Supports trial governance reviews and contributes to clinical development strategy and PD- development.
• Interacts with external stakeholders to drive strategy and PDD development.

Skills

Clinical leadership

Cross-functional collaboration

Regulatory submission

Communication skills

Education

BS with 12 yrs experience

PhD with 7 yrs experience

Job description

Pfizer is seeking a Global Development Lead (GDL) in a hybrid role, accountable for clinical development across assets in internal medicine. The GDL will lead cross-functional teams in design, execution and interpretation of studies for worldwide regulatory submissions, and oversee development plans, target product profiles, and regulatory activities.

The role involves contributing to pediatric development plans, interacting with trial clinicians, external partners, and external stakeholders to