Executive Director, Medical Affairs Oncology

Tarrytown, NY, United States
Sep 16, 2020
Required Education
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.


The Executive Director, Medical Affairs Oncology will fulfill an important strategic leadership role reporting into the VP of Medical Affairs Oncology. He/She has high visibility in the organization, participating with senior management in developing strategic objectives and implementing functional Medical Affairs plans for Oncology assets in phase 2 and beyond with the benefit of the patient at the forefront.

The Executive Director leads key Medical Affairs projects that require breadth of experience and strong business acumen. He/She brings innovation and critical thinking to planning Medical Affairs related processes, determines organizational structures, directs cross-functional teams (including medical, scientific & commercial directors, biostatistics, clinical operations, safety, regulatory, marketing planning, business development and corporate communications), and assures optimal partnership for products developed in an alliance setting.

The Executive Director plays a critical role in establishing/maintaining professional relationships with key medical experts in the field of Oncology, all aspects of medical product support and appropriate collaboration with the commercial group.

Job Duties:
• Responsible for directing, developing and enhancing one or more critical functions within the medical affairs department.
• Ensures that strategic long term and annual conceptualization and execution of US and Global Medical Affairs plans for late stage Oncology products/compounds are appropriately aligned with corporate strategies.
• Plans strategically and executes, through line management where in place, appropriate medical support for Oncology product(s) and candidates which includes, but is not limited to the following responsibilities:
- Development and oversight of implementation of US and globally focused medical strategy and tactics, including internal/external disease area/product training, annual medical planning, scientific communications, and collaborations with experts.
- Application of therapeutic/disease area expertise and addressing current and future medical needs in clinical practice to inform medically appropriate use of investigational medicines.
- Providing strategic leadership and providing therapeutic area and medical affairs expertise for molecules in the development stage.
- Oversight and hands on support in management, generation and dissemination of clinical and non-clinical data that supports the medical strategy and results in high quality publications.
- Leadership to ensure an aligned and effective collaboration between Regeneron and a business partner's Medical Affairs organization as well as the relevant business partner's US and global franchise teams.
- Standing or ad-hoc membership for various cross-functional and cross-alliance teams; providing medical perspectives to the global and US strategic and medical organizations.
- Oversight of formation, refinement and execution of a robust Phase 3b/4 plan.
- Working closely with clinical sciences colleagues to optimize the development of phase 1, 2 and registrational trials.
- Oversight of design, conduct, analysis and reporting of Medical Affairs clinical trials. Provides oversight to ensure timely submission and delivery of high-quality clinical trial documentation, implementation and execution.
- Development and cultivation of long-term strategic partnerships with clinical experts, societies, collaborative groups, advocacy groups, and other external stakeholders representing Regeneron.
- Oversight of Scientific Review Committee reviewing Investigator-Initiated Studies Research Proposals.
- Oversight of Medical Affairs representation on the Regeneron Copy Review Committee.
- Champion of high standards of compliance, ethics and patient safety, putting patients at the center of all actions.
- Staying abreast of current developments within pertinent medical and scientific therapeutic area through familiarity with current literature, attendance at medical society meetings, professional associations and others.
- Accountability for creating and managing resources within annual Medical Brand Budgets, and expenses.
- Performs oversight of medical monitoring of post-registrational trails and is the final signatory of documents related to interpretation of patient level data where necessary, if in possession of a medical degree.
• Directs, through line and matrix management, multiple functions and therapeutic areas within Medical Affairs.
• Determines organizational structures and operational direction for one or more critical functions within Medical Affairs.
• Is accountable for the overall organizational morale, team effectiveness and talent management.
• Leads by example and is viewed across the organization as a role model.
• Serves as principal spokesperson for the medical affairs function on highly significant matters.
• Interacts internally and externally with senior management and/or functional heads requiring negotiation of difficult matters.
• Takes on a positive leaderships role when there is ambiguity and little or no direction.
• Plays a key role in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
• Speaks as principal spokesperson for the function or organization on significant matters.
• Works in a goal/objective oriented manner within formalized process to plan and execute annual goals in alignment with the corporate annual goals and core business strategy.
• Demonstrates excellent people management skills, as well as collaborative efforts with relevant stakeholders within and outside REGENERON.

• MD required.
• 14+ years total experience post medical degree, with at least ten years progressive experience in Pharmaceutical or Biotech Industry working in Medical Affairs and/or Clinical Research & Development or related fields.
• Possesses clinical knowledge in a range of diseases within Oncology.
• Industry experience and knowledge of planning, executing and reporting clinical trials with post-marketing experience required.
• Prior experience with working in an alliance setting strongly preferred.

The ideal candidate will demonstrate the following competencies:
• Hands-on style with proven ability to work effectively in a fast paced, rapidly changing and expanding environment and juggle multiple projects.
• Strong interpersonal skills.
• Deals with scientific concepts and complexity with confidence.
• Knows how to get things done both through formal channels and the informal network and can inspire and motivate teams across the organization.