Associate Director, Medical Affairs-Strategic Business Planning & Execution,

Role Responsibilities:
- Drive execution of Global and US Medical Affairs tactics as defined in Medical Product Plans.
- Schedule and facilitate team meetings; achieve project goals and provide status updates within timeline, resources, and budget.
- Create and maintain collaborations with internal/external partners (e.g., Global Development, Medical Operations, Commercial).
- Own integrated medical tactical plans; track progress and ensure completion of tactics on time, scope, and within budget.
- Identify and resolve risks, delays, and changes affecting tactical execution.
- Oversee Ph IV, Registry, IIS, and Strategic Collaboration Studies for progress, timelines, and budgets.
- Manage operational plans and associated budgets with Finance.
- Support processes for publication/communication plans, advisory boards, expert consultations, steering committees, and vendor management.
- Serve as liaison between Medical Affairs and external vendors.
- Develop and drive new processes/tools to enable vertical and horizontal integration; act as ambassador for systems/tools including AI.
- Identify/communicate business process enhancements or technical issues to management and Global Development Systems.
- Ensure compliant execution; assist with reviewing/developing departmental procedural documents aligned to SOPs, regulations, and guidance.

Qualifications:
- Bachelor’s degree with 10+ years experience; MBA with 8 years or advanced degree with 5+ years (preferred).
- Required: active project management experience in pharmaceutical/biotechnology clinical development.
- Preferred: experience in medical affairs or launch.
- Strong knowledge of FDA/EMA/ICH regulatory requirements.
- Ability to initiate and lead large cross-functional projects to completion.
- Demonstrated project management skills.
- PMI certification preferred.

Application:
- “Apply now”.