Objectives/Purpose:
- Lead development and advancement of Global Patient Access (GPA) strategies across programs, aligned with enterprise priorities, regulatory requirements, and product lifecycle needs.
- Drive data-driven, technology-enabled strategy development using digital platforms, analytics, and insights to optimize program design and performance.
- Enable consistent execution of the GPA Strategy & Operations operating model to ensure scalable, standardized implementation across regions.
- Influence cross-functional stakeholders to deliver integrated, patient-centric access strategies that support timely and compliant access globally.
Accountabilities:
- Lead end-to-end strategy development and execution of pre-approval access programs with Global Product Teams and Regional/LOC stakeholders.
- Translate enterprise/portfolio priorities into actionable, scalable GPA strategies with geographic consistency.
- Support operating model execution via training, tools, communications, and process improvements for standardization, efficiency, and scalability.
- Leverage digital platforms (e.g., One Patient Access) for program execution, tracking, and performance visibility.
- Use data and analytics (with systems teams) to optimize program design and enhance reporting; drive adoption, continuous improvement, and scalable delivery.
- Champion data standardization and quality to ensure accurate, consistent, compliant data.
- Represent GPA on global cross-functional teams, influencing strategy, timelines, and execution decisions.
- Drive alignment across Medical, Clinical, Regulatory, Supply, and Commercial teams.
- Ensure compliance with global regulatory requirements, internal policies, and SOPs; support audit/inspection readiness; monitor and manage program budgets/resources.
Required:
- PhD/PharmD (~3+ years) or MS (~6+ years) or BS (~8+ years) in clinical research or expanded access in pharma or CRO.
Preferred:
- Advanced degree in a Health science field (e.g., Nursing, Pharmacy, Public Health).
- Previous experience managing expanded access programs.
Additional Information:
- Travel: ~10%, including overnight and international travel.
Application instructions:
- Apply via the βApplyβ button.