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The Associate Director, Managed Access Programs will be responsible for both setting up global managed access programs (including post-study drug access programs) and ensuring their effective operational delivery. Working in close partnership with the Senior Director, Managed Access Programs, this role will be responsible for driving operational excellence, ensuring compliant and efficient execution, and contributing to the development of strategic approaches that enable timely patient access to investigational medicines. The position involves both hands-on program management and cross-functional collaboration, requiring strong organizational, project management, and communication skills. This role will report to the Executive Director, Managed Access Programs.
Key Responsibilities
* Program operations and oversight : support the set-up and execution of managed access programs across multiple geographies; co-develop, review, and maintain program-related documents (such as protocol, informed consent forms, treatment plans); monitor overall program performance.
* Vendor & Partner management : set-up, review and ongoing management of Statement of Work, oversee third-party vendors providing operational services, ensuring high-quality delivery against agreed timelines and metrics; function as a point of contact for external partners to ensure smooth coordination and issue resolution.
* Cross-functional collaboration : partner with internal stakeholders (clinical supply, safety, quality, local medical) to ensure compliant program execution and facilitate alignment across functions to resolve operational challenges and maintain program continuity.
* Metrics, reporting and compliance : track and report program metrics (number of countries, sites, patients; ensure consistent and accurate monthly reporting), ensuring accuracy of patient numbers and key milestones.
* Strategic contribution : provide input into strategic decision-making based on operational insights and overall managed access experience.
Qualifications & Experience
* Educational Background : Degree in a relevant field (e.g., life sciences, pharmacy, public health) with at least 2 years of experience in managed access required. Advanced degree preferred.
* Industry Experience : Proven experience with managed access programs and demonstrated experience with managing vendors. Previous experience in clinical operations and the drug development process is preferred.
* Regulatory / Compliance Knowledge : In-depth knowledge of global and local regulations and guidelines related to managed access programs (including post-study drug access).
* Communication Skills : Excellent communication, interpersonal and presentation skills.
* Strategic Thinking : Proven history of leading through influence and working across complex, global organizational matrices.
* Adaptability : Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities. Initiative-taking, assertive, and confident to act with urgency. Proven ability to work with a high level of integrity, accuracy, and attention to detail.
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