Senior Director, Medical Affairs, Immunology

Location
Tarrytown, NY, United States
Posted
Aug 05, 2019
Ref
16328BR
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:
Medical Affairs at Regeneron
Our medical affairs physicians and scientists are experts on our medicines and form an extremely valuable part of our global development organization. We serve as an important liaison between Regeneron and the scientific and healthcare community. Medical Affairs is organized in an optimally aligned matrix structure for delivery of therapeutic and functional area expertise.

Your responsibilities
The Senior Director of Medical Affairs will fulfill an important strategic leadership role and has high visibility in the organization, reporting into the Executive Director of Medical Affairs. He/she will spearhead the development of medical strategy, planning & execution of medical affairs activities at Regeneron with the benefit of the patient at the forefront and ensures medical activities are delivered with integrity and scientific accuracy. He/she will provide scientific and medical leadership by thoroughly understanding Immunology and serving as a key scientific and medical resource.
The Senior Director will lead a multifunctional Medical Product Team (MPT) with global and US focused deliverables, within a matrix organization, consisting of colleagues within the medical affairs group (including field medical, medical operations, medical education, medical information, HEOR, publication management and medical statistics). The Senior Director will represent Regeneron medical affairs and ensures alignment working closely with research & development, commercial, access & reimbursement, and patient advocacy colleagues. He/she will also represent Regeneron towards external collaborators such as health care practitioners, research groups, payers and alliance partners.

Job Duties:

The Senior Director, Medical Affairs:

• Develops and oversees implementation of US and ex-US focused medical strategy and tactics for one asset, including scientific communications and publications, annual medical planning, field communications, and collaborations with experts

• Applies therapeutic/disease area expertise and clear business understanding to address current and future medical needs in clinical practice with medically appropriate use of investigational medicines.

• Oversees and provides 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.

• Leads a cross-functional team and continuously strives for alignment across the organization (and the alliance if applicable).

• Acts as standing or ad-hoc member for various cross-functional and cross-alliance teams; provides scientific/medical perspectives to the global and US strategic and medical organizations.

• Co-leads the formation, refinement and execution of a robust Phase IIIb/IV plan

• Supports the design, conduct, oversight, analysis and reporting of Medical Affairs clinical trials. Ensures timely submission and delivery of high-quality clinical trial documentation, implementation and execution.

• Continues to develop and cultivate long-term strategic partnerships with clinical experts, societies, collaborative groups, advocacy groups, and other external stakeholders representing Regeneron.

• Establishes priorities for support of investigator-initiated studies and serves as the Chair on an internal Scientific Review Committee.

• Ensures accuracy of training material for scientific and product information

• Oversees medical review and approval of all promotional materials.

• Ensures goals and objectives are met and projects completed on time to high standards and within budget.

• Is responsible for optimal medical affairs resource allocation across the spectrum of a product's life cycle.

• Oversees development and forecasting of project budgets across assets.

• Champions high standards of compliance, ethics and patient safety, putting patients at the center of all actions.

• Accomplishes the majority of work with independence.

• Performs medical monitoring of post-registrational trails and is the signatory of documents related to interpretation of patient level data where necessary, if in possession of a medical degree
Managerial responsibility and related expectations:

• Potential to manage Medical Director and/or Associate Director as direct reports

• Interacts internally and externally with senior management and functional heads

• Represents Medical Affairs on the Strategic Product Team.

• 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:

Qualifications and skills:

• Advanced degree strongly preferred (MD, PhD or PharmD).

• 12+ years of related industry experience in medical affairs required.

• Solid background and experience in drug development and life-cycle development of related products required.

• Specialized knowledge: Immunology required.

• Experience with working in an alliance setting strongly preferred.

• Ability to lead business and technical discussions internally and externally and explain scientific/medical concepts to all levels.

• Ability to cultivate and maintain relationships with key opinion leaders in the relevant fields.

• Ability to establish trust through the consistent demonstration of scientific expertise and satisfactory follow-through on requests from key opinion leaders

• Strong leadership and management skills.

• Attention to detail in analyses, deliverables and communications.

• Strong presentation and communication skills; must be able to provide succinct, strategic, and actionable insights to senior management.

• A proactive self-starter who can lead work and manage others independently, with the ability to see the next step and take action without prompting.

• Ability to juggle multiple projects.

• Thorough understanding of the healthcare environment including all external stakeholders.

The ideal candidate will demonstrate the following competencies:

• Ability to work effectively in a fast paced, rapidly changing and expanding environment.

• Outstanding work ethic and integrity, including high ethical and scientific standards

• Deals with scientific concepts and complexity with confidence.

• Makes the best decision possible based on a mixture of data analysis, wisdom, experience and judgement.

• Strong interpersonal skills particularly motivational, negotiation, listening, judgment, analytic, and conflict management skills, demonstrated by ability to lead teams.

• Establishes and maintains effective relationships with internal and external colleagues and gains their trust and respect.

• Creates a climate in which people want to do their best and can motivate many ki • nds of direct reports and team or project members.

• Can deal comfortably with senior management.

• Is action oriented and full of energy for the things he/she sees as challenging

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.