Program Manager overseeing project scope, plans, and schedules for moderately complex programs at IQVIA. Ensuring program success through effective stakeholder management and risk monitoring.
PF
Hybrid Director, Regulatory Program Management – Submission Strategy, Oncology
Posted 2 months ago
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
Requirements
- 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.
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
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