About the role

Director overseeing regulatory program management and submission strategy in Oncology. Leading execution and alignment of regulatory deliverables to meet business needs and timelines.

Responsibilities

Provides comprehensive program management, ensuring alignment and execution of Pfizer Oncology’s regulatory strategic and operational deliverables
Serves as the regulatory program operational leader, ensuring all cross-functional regulatory deliverables are achieved on or ahead of schedule
Offers leadership in regulatory strategy and planning
Ensures alignment of regulatory/submission strategy with overarching asset strategy
Provides cross-functional operational leadership to the Global Regulatory Strategy Team
Influences leadership across functional lines to ensure efficient delivery of regulatory projects
Leads the regulatory team in the preparation, implementation, maintenance, communication, and management of integrated risk management plans
Ensures effective, accurate, and timely communication of regulatory information
Utilizes negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross-functional team performance
Provides comprehensive project management for regulatory submission activities for initial and supplemental market authorizations

Bachelor's degree in one of the disciplines related to drug development or business required
Advanced degree (PhD, PharmD, MBA) desirable
Mastery of program management skills and significant expertise in drug development (Oncology preferred)
Directors are strongly preferred to have 10 or more years of relevant experience
Experience leading the planning and execution of major regulatory submissions (e.g. NDA/BLA/MAA) is required
Strong track record of performance, delivery and team effectiveness in a complex matrix team environment
Proven ability to drive results
Extensive knowledge and experience in drug development, medical, and/or commercial disciplines with proven ability to think strategically and operationally
Demonstrated ability to translate strategy into effective operational goals and tactical plans
Strong leadership, negotiation, interpersonal, communication, and meeting facilitation skills
Knowledge of and experience with clinical operations/clinical trial execution is desirable
Knowledge of end-to-end drug development (pre-clinical through LOE) is desirable
Experience with Microsoft Project, Planisware, and/or OnePager is preferred.

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