Global Development Lead managing clinical development for Internal Medicine at Pfizer, leading cross-functional Clinical Development Teams and ensuring global regulatory compliance.
Responsibilities
Represent Clinical on the Global Medicine Team
Lead the cross-functional Clinical Development Team
Create and gain endorsement for the Clinical Development Plan
Accountable for design, execution and interpretation of studies
Support worldwide regulatory submissions
Partner with external companies in support of Pfizer’s Partner of Choice model
Provide regulatory submission support (DSUR, PBRER) and product defense
Ensures compliance with internal SOPs and external regulatory standards
Requirements
BS with 12 yrs or PhD with 7 yrs, relevant clinical/industry experience
Experience leading large cardiometabolic late-stage development programs
Relevant experience and 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, adverse event management
Demonstrated clinical/medical, administrative, and project management capabilities
Effective verbal and written communication skills
Demonstrated experience managing and training large teams in clinical development
Demonstrated experience in designing and launching large teams preferred
Benefits
Comprehensive and generous benefits and programs to help our colleagues lead healthy lives
401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation
Holiday and personal days
Paid caregiver/parental and medical leave
Health benefits to include medical, prescription drug, dental and vision coverage
Job title
Global Development Lead, Internal Medicine – Sr. Director
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