Senior Project Manager: Post Marketing Studies (12 month contract)
We are seeking a high-caliber Senior Project Manager to bridge the critical gap between clinical development and long-term patient access.
Key Responsibilities
* Global Program Management: Lead the end-to-end setup, implementation, and oversight of Post-Trial Access (PTA), Expanded Access Programs (EAPs), and Named Patient Programs (NPPs).
* Study Oversight: Manage the operational delivery of Observational and Low-Interventional studies, ensuring data integrity and regulatory compliance.
* Investigator Initiated Trials (IITs): Act as the primary point of clinical oversight for IITs, ensuring alignment with company strategy and safety standards.
* Vendor & Budget Accountability: Drive full lifecycle management of external vendors and CROs. You will hold full accountability for program budgets, including forecasting, tracking, and reconciliation.
* Patient Continuity: Develop and execute strategies to ensure seamless drug access for patients following the completion of clinical trials across various global territories.
Candidate Profile
* Experience: 3+ years of direct experience managing post-marketing studies, EAPs, or NPPs ina Biotech/pharma environment.
* Self-Starter Mindset: You are highly self-driven and comfortable operating with minimal oversight. You prefer building a path to waiting for one to be cleared.
* Technical Expertise: A deep understanding of the regulatory and logistical nuances of managed access and low-interventional study designs.
* Communication: Exceptional stakeholder management skills, with the ability to collaborate across Clinical, Medical Affairs, Supply Chain, and Quality functions.
* Resilience: You thrive in a lean, agile environment where adaptability is a core requirement for success.
Work Style
Full time, onsite 3 days a week in Basel
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