Req Number: 1555
Title: Director/Senior Director, Medical Affairs
Division: Clin Sci & Reg Dev
Location: Tarrytown, N.Y.

Description:
Summary:
-Assumes a leadership role in the strategic planning and execution of Medical Affairs activities supporting the Life Cycle Management for the company's flagship metabolic products, with rilonacept (IL-1 Trap) which is the first product for the company to be approved and launched.
-Collaborates and takes medical leadership role within cross-functional teams of medical as well as commercial and corporate professional including medical and scientific directors, biostatics, clinical operations, safety, regulatory, marketing planning, business development and corporate communications; interface with senior management.
-Critical role in establishing/maintaining professional relationship with key medical experts in the field of inflammation, rheumatology, immunology and related therapeutic areas.
-Responsible for all aspects of medical product support and appropriate collaboration with the commercial group. Leads the Investigator Initiated Studies (IIS) program and phase 4/postmarketing studies program
-All activities, internal and external must adhere to rigorous corporate standards and government/industry regulations and compliance standards.

Key Functional Responsibilities:
-Strategic Planning and execution of medical product support for Rilonacept and future product candidates for inflammatory disorders which includes but is limited to the following responsibilities:
-Strategic input and day-to-day advice on commercial plans from the scientific and medical affairs perspective.
-Strategic planning and oversight of a phase 3b/4 clinical trails program and global patient registry including protocol development and conduct of all clinical studies in adherence to Company SOPs and standards and government/industry regulations. Ensures final accuracy of Phase 3b and 4 clinical trials data and its timely availability, in appropriate format and works closely with Regulatory in developing plans for IND and/or sNDA submissions.
-Chairs committee to review and approve requests by investigators for investigational drug supply and/or research grants. Oversees all aspects of the IIS program for inflammation.
-Planning, oversight of and active participation in execution of communications plan supporting the scientific communications needs and core strategy (i.e. planning for medical society presence, abstracts, and publications, writing of abstracts/publications as appropriate and required).
-Input to product labeling and participation in the review/approval process of promotional and educational materials.
-Medical/scientific training of internal staff (RSMs, medical information staff) on Rilonacept and future product candidates as well as disease related aspects.
-Medical and scientific expertise to core business strategy and marketing/business development plans.
-Medical support for Managed Care initiatives including presentations to Formulary Boards and decision makers.
-Professional medical expertise to Commercial, Sales, Marketing and Legal functions on marketed products and drugs currently in approval process.
-Active participation in internal and external training initiatives (Medical Science Liaisons, professional representatives, training of other internal personnel as well as participation in Speakers Training within the scope of Speakers Bureaus).
-Medical Affairs representatives on the Copy Review Committee responsible for the review and approval of all proportional, 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, researchers 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.
-Take 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.

Experience:
Education:
-MD (internal medicine) with fellowship training in Rheumatology, Immunology or related discipline preferred. Will consider Ph.D., Pharm D candidates with significant industry experience in clinical and, medical affairs.

Experience:
-10+ years of Clinical and related industry experience.

knowledge and Specialized Skills:
-Extensive clinical knowledge in inflammatory disorders, rheumatology and/or immunology; understanding of clinical pharmacology.
-Understanding of clinical trials process with demonstrated ability to design and implement programs and initiatives directed towards defined strategic objectives. Understanding of regulatory approval process requirements outside the US (eg EMEA) desirable. Experience with patient registries for marketed products desirable.
-Experience in publishing clinical/research work. Experience in managing publications processes, working with external and internal authors, journal editors and, as required and when appropriate, medical writers.
-Demonstrates 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.
-Strong interpersonal, verbal and written communication skills. Ability to form strong and constructive internal as well as external professional relationships.
-Ability to present complex (medical) information to others effectively.
-Strong team player with ability to take active leadership role and lead cross-functional teams towards desired outcomes.
-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'
-Ability and desire to manage at times intense workloads.
-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 all medical affairs 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.