Senior Medical Director- Rheumatology
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.
Assumes a leadership role in strategic planning and execution of Medical Affairs activities supporting Life Cycle Management for company's metabolic products. Collaborate and takes medical leadership role within cross-functional teams of medical affairs as well as commercial and corporate professionals including medical & scientific directors, biostatistics, clinical operations, safety, regulatory marketing planning, business development and corporate communications; interfaces with senior management.
Plays critical role in establishing/maintaining professional relationship with key aspects of medical product support and appropriate and compliant collaboration with the commercial group. Sets policy and direction to ensure that all activities, internal and external adhere to rigorous corporate standards and government/industry regulations & compliance standards.
Provides strategic planning, advice and execution of medical product support for sarilumab and future product candidates from scientific and medical affairs perspective which includes but is not limited to the following responsibilities:
• Develops and ensures implementation of strategic planning for new product launches and post launch products.
• Establishes and maintains process to review and approve requests by investigators for investigational drug supply and/or research grants.
• Manages planning, oversight of and active participation in execution of communications plan supporting scientific communications needs and core strategy (i.e. planning for medical society presence, abstracts, and publications, writing of abstracts/publications as appropriate and required)
• Provides input to product labeling and participation in the review/approval process of promotional and educational materials.
• Ensure medical/scientific training of internal staff including Regional Scientific Managers (RSM), medical information staff) on sarilumab and disease related aspects.
• Demonstrates medical and scientific expertise to core business strategy and marketing/business development plans.
• Provides medical support for Managed Care initiatives including presentations for Formulary Boards and decision makers.
• Lends professional medical expertise to Commercial, Sales, Marketing and Legal functions on marketed products and drugs currently in approval process.
• Serves as Medical Affairs representative on Copy Review Committee responsible for review and approval of all promotional, educational and related materials supporting Company products, ensuring medical/scientific accuracy and fair and balanced presentation.
• Establishes/maintains appropriate professional relationships with key medical experts, researches and academic institutions within pertinent medical /scientific community. Responsible for the identification of and appropriate interaction with advisors (in accordance with OIG) and the planning/facilitation of scientific Advisory Boards as applicable.
• Serves as interface between US and global franchise teams as applicable in coordinating medical activities.
• Takes proactive initiatives to stay abreast of current developments within pertinent medical and scientific therapeutic area through familiarity with current literature, attendance at medical society meetings, professional associations and other.
Managerial responsibility and related expectations:
• Identifies with and actively communicates/applies company values on a consistent basis.
• Demonstrates Core Competencies as defined for Regeneron managers on consistent basis.
• 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.
• Takes leadership role and/or participates as active member on cross functional teams. Leads a multifunctional team with line accountability to functional disciplines. Ensures teams conduct activities with appropriate sense of urgency.
• Demonstrates excellent people management skills, as well as collaborative efforts with relevant stakeholders within and outside Regeneron.
• Provides accountable for creating and managing resources within annual Medical Brand Budgets, and expenses.
Knowledge and Specialized Skills:
• Possesses extensive clinical knowledge in pain/ rheumatology/ immunology/inflammation.
• Demonstrates wide range of acquired skills as head-office medical affairs product lead, with global and US remit
• Understands the clinical trials process with demonstrated ability to design and implement programs and initiatives directed towards defined strategic objectives. Understands the FDA approval processes, understanding of regulatory approval process requirements outside the US (eg EMEA) desirable.
• Demonstrates an analytical approach to problem solving and ‘evidence-based decision making'.
• Effectively interacts with and collaborates at all levels in the organization, including effective interface at the senior management level.
• Demonstrates strong interpersonal, verbal and written communication skills. Ability to form strong and constructive internal as well as external professional relationships.
• Demonstrates ability to present complex (medical) information to others effectively.
• Able to take an active leadership role and guide cross-functional teams towards the desired outcomes.
• Possesses a desire to ‘jump in' and collaborate with cross-functional team in preparation for the first anticipated product launch for the Company; desire to participate in supporting a product launch at an important time for the organization and willingness to ‘go the extra mile'.
• Demonstrates a strong ability and desire to collaborate with the commercial/marketing organization in an appropriate manner to ensure commercial strategy, plan and execution incorporate medical input and direction.
• Ensure that all medical affairs activities in support of the product adhere to all relevant industry regulations and guidelines, such as OIG and The Company's Code of Business Conduct and Ethics.
Medical Degree from an accredited US or foreign medical school with three or more years of postgraduate
medical training is preferred. Board certified in internal medicine, preferably fellowship training in rheumatology or related discipline desirable or
PhD with three or more years of postgraduate training or fellowship training in rheumatology or related discipline.
Ten (10) years total experience post medical degree, inducing clinical practice, with at least five (5) years progressive experience in Pharmaceutical or Biotech Industry working in Medical Affairs and/or Clinical Research & Development or related fields. Industry experience in planning, executing and reporting clinical trials; management of staff and/or departments as part of experience desirable. Prior experience working in a matrix organization as well as cross-functional collaboration with commercial/marketing departments strongly desired.
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.
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Requisition Number: 11898BR