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, and/or specifications (e.g., FDA, EMA, ICH) required. Experience working within an Alliance highly desirable.

Additional requirements include: 
•    Strong understanding & proficiency in excel including pivot tables, conditional formatting, forecasting & trending and PowerPoint including creating, formatting, embedding, linking interactive presentations.
•    Consistent & reliable attention to detail, high level of accuracy
•    Strong interpersonal skills particularly motivational, negotiation, listening, judgment, analytic, and conflict management skills, demonstrated by ability to lead.
•    Must be a practical thinker, able to identify simple, realizable solutions.
•    Thorough understanding of the healthcare environment. 
•    Must possess the business sense necessary to interpret and draw business insights from data analysis to formulate recommendations and implement action plans.
 

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)