Director, Medical Affairs (Infectious Disease)
The Medical Director is responsible for the development of medical strategy, planning & execution of assigned medical affairs activities at Regeneron. This hire will provide scientific and/or medical leadership by thoroughly understanding infectious diseases and serving as a key scientific/ medical resource specifically with regards to Regeneron’s COVID-19 related development activities.
The Medical Director will work in a multifunctional, matrix organization, working closely with colleagues within the medical affairs group (including field medical, medical operations, medical education, medical information, HEOR, publication management and medical statistics), as well as those in research & development, commercial, access & reimbursement, and patient advocacy. He/she will also collaborate with external collaborators such as health care practitioners, research groups, government bodies, payers and potential alliance partners.
A typical day in the life may include the following:
- Defines strategy, sets annual goals and ensures compliant execution of medical affairs activities.
- Maintains deep scientific and medical knowledge of relevant therapeutic/disease areas as well as an understanding of patient and physician interactions and clinical decision making and impact.
- Provides matrix management of the cross-functional Medical Product Team (MPT)
- Is responsible for medical affairs activities consisting of data generation, data analysis and interpretation. Plays a key role in developing evidence generation strategy and execution of post-registrational studies, including interventional and observational research.
- Develops and executes early access programs in challenging environments
- Provides strategic direction and scientific and medical support for publications and presentations as needed, working closely with the Publication Manager.
- Leads evaluation of investigator-initiated study applications.
- Provides substantial input and reviews development of standard response letters to medical inquires on Regeneron products and the Global Value and AMCP Dossiers.
- Participates in scientific engagement with external communities in order to educate and advance scientific and medical understanding of relevant disease areas, including the management of disease, standards of patient care and roles of our medicines.
- Develops medical content for congresses, symposia and advisory boards and leads such activities.
- Presents scientific/ medical materials to diverse audiences (e.g. physicians, pharmacists, marketing/medical agencies, and other key stakeholders) in meeting, advisory and/or consulting settings.
- Actively participates in and contributes to the cross-functional Medical Product Team with medical/ scientific knowledge while considering the needs of external collaborators, including payers.
- Provides scientific and medical input and ensures integrity of scientific content for promotional activities and sales training. Is the lead medical reviewer in the review committee responsible for the review and approval of promotional, educational and related materials supporting Company products, ensuring medical/ scientific accuracy and fair and balanced representation.
- Supports field medical activities.
- Assesses medical education needs and develops internal and external educational activities.
- Works with finance, multiple functions with Medical Affairs and Project Manager to develop and forecast project budgets for medical affairs activities.
- Provides medical training for internal staff (including Field Medical colleagues, medical information, commercial, and sales) on products and disease related aspects.
- Potential of direct line management of associate medical director.
- Performs medical monitoring of post-registrational trails and is the signatory of documents related to interpretation of patient level data where necessary.
This job may be for you if you have the following:
- Physician (M.D. or equivalent), with expertise in infectious disease and/or emergency medicine preferred
- Clinical, research and/or drug-development experience in infectious disease and/or emergency medicine
- Minimum of 10 years’ experience in the pharmaceutical industry and/or medical affairs is required.
- Experience and success in working in a matrix, cross-functional environment; excellent collaboration skills; experience working across functions to achieve results.
- Must be able to demonstrate excellent medical communication skills.
- Must be able to clearly demonstrate a thorough understanding of the healthcare environment including all external stakeholders.
- Must be able to demonstrate understanding of medical affairs accountabilities for evidence generation, external engagement and internal advice; direct experience preferred.
- Must demonstrate disease area expertise and appropriate medical and/or clinical experience.
- Outstanding work ethic and integrity, including high ethical and scientific standards.
- Ability to work effectively in a fast paced, rapidly changing environment. Works cooperatively with others across the organization to achieve shared objectives.
- Comes up with new and unique ideas that move the science forward and add value. Deals with scientific concepts and complexity comfortably.
- Has the functional and technical knowledge and skills to do the job at a high level of accomplishment. Has broad knowledge and perspective and is future oriented.
- Makes good decisions based upon a mixture of analysis, wisdom, experience, and judgment. Makes these decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure.
- Strong interpersonal skills particularly motivational, negotiation, listening, judgment, analytic, and conflict management skills, demonstrated by ability to lead teams.
- Ability to work independently and engage in collaborative decision making, to complete tasks in a timely fashion, and function in a fast-paced and rapidly expanding environment. Must be a practical thinker, able to identify simple, realizable solutions.
- Demonstrated matrix leadership qualities; clearly assigns responsibility for tasks and decisions; sets clear objectives and measures. Monitors process, progress, and results.
- Can effectively cope with change, can shift gears comfortably, can decide and act without having the total picture, can comfortably handle risk and uncertainty.
- Is effective in a variety of formal presentation settings: one-on-one, small and large groups, with peers, direct reports, and supervisors.
- Establishes and maintains effective working relationships with internal and external colleagues and gains their trust and respect.
#REGNPSIND #MDJOBS #MDJOBSMA