Director, Medical Affairs Project Management

As a Director Strategic Business Planning & Execution you will provide strategic & operational project management excellence to the leadership of the I&I Global Medical Affairs Franchise. We work cross functionally (medical, commercial, development) and across the Regeneron/Sanofi Alliance to compliantly influence in a most collaborative way, in support of Regeneron’s Scientific Share of Voice securing positive patient outcomes. 

You are expected to responsible for the planning, execution & management of Global & US Medical Impact Team Meetings, Advisory Board/Scientific Committee, Symposias, and other critical business needs. Responsibilities will include the oversight to all Global Medical Affairs Interventional & Non-Interventional Studies, ensuring a base scientific understanding to guide teams ensuring study achievements. 

This position will requiree you to be on-site for a minimum of 3 days/week at our Sleepy Hollow, NY offices. We cannot offer a fully remote option. If eligoible, we can offer relocation assistance.

A typical day may include: 
Supports I&I Global Medical Affairs Vice President, TA Heads & Medical Directors within the Franchise leading the execution of Global & US Medical Affairs tactics as defined in the Medical Impact Plans.
•    Drive the creation of the Annual Medical Affairs Strategic & Tactical Plans
•    Effective positive collaboration with Global Clinical Operations, the Alliance & other functional areas as applicable
•    Conducts core team and in-line medical functional meetings.
•    Responsible for integrated tactical plans, track progress & reports out status.
•    Ensures ownership for all tactics & tactics are completed on time & within budget.
•    Facilitates the resolution of risks, delays &/or changes on the tactical execution.
•    Awareness & understanding of Phase 4, Registry, IIS & Strategic Collaboration Studies
Translates key project deliverables & strategic program imperatives resulting in seamless execution.
Manages operational plans & associated budgets working in collaboration with Finance.
Provides project-related support to all process-related aspects with regards to the implementation & execution of publication plans, advisory boards/scientific committees, expert consultations, steering/scientific committees & management of outside vendors.
Ensures compliant execution of all Medical Affairs activities & assists with the review & development of departmental procedural documents in accordance with agency regulations & guidance.
Support the Global Medical Affairs TA Heads in the development & management of department metrics & oversees/leads special projects as needed (e.g., Dashboard, Integrated Project Plans, Goals & Achievements) for TA supported.
Ensures well-aligned & effective collaboration between internal Regeneron functions, business partners relevant to the US & Global franchise teams & external Alliance teams; ability to use sound judgment when to bring up to leadership.
Support the execution & building of strategic needs around business process enhancements & designing adequate platforms to support current & future business needs
Accountable for managing project budgets & related expenses; assists Global Medical Affairs TA Heads with departmental-wide budget planning & forecasting.
Ensure that all medical affairs activities in support of the product adhere to all relevant industry regulations & guidelines, such as Office of Inspector General (OIG) & Regeneron’s own Company’s Code of Business Conduct & Ethics

This may be for you if you: 
•    Can demonstrate experience working in a goal focused manner within formalized process to plan & implement annual goals in alignment with the corporate annual goals & core business strategy.
•    Able to take an active leadership role & guide cross-functional teams towards the desired outcomes.
•    Ability to work effectively in a fast paced, rapid response, constantly evolving & expanding environment.
•    Outstanding work ethic and integrity, including high ethical and scientific standards.
•    Demonstrates ability to translate & present complex (scientific) information to others effectively.

To be considered you are required to have a bachelor’s degree (MBA preferred) with 7+ years’ experience leading initiate & leading large, cross-function projects, operationally & strategically, seeing it through completion. Current working experience in the healthcare/pharmaceutical/ biotechnology field with working understanding of drug development (early & late-stage development). Strong knowledge of applicable regulatory agency regulations, guidelines,