Executive Director, Medical Affairs Oncology

Location
Tarrytown, NY, United States
Posted
Sep 16, 2020
Ref
21409BR
Required Education
Doctorate/PHD/MD
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.

Summary:

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.

Requirements:
• 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.