Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.
The Senior Director will lead the development of an Integrated Medical Plan (MSLs, IME, Medical Communications and Publications, Health outcomes, Safety and Clinical Research (phase IIIB-IV and ISTs)) and annual budget for assigned brand(s)
Lead and monitor the execution of the Integrated Medical Plan to ensure on-time and on-budget delivery of all tactical activities or deliverables.
Communicate the details and progress of the Medical Plan to Senior Management, the Core Team and all parties responsible for execution.
Ensure strategic and cross-functional alignment across the organization and any joint ventures to achieve the medical mission of supporting safe and appropriate use of a particular brand(s)/projects .
Provide medical leadership and expertise to sales, marketing, legal and regulatory functions for marketed products and drugs in development.
Provide medical review or support to the medical designee for scientific review and approval of promotional material and medical materials in compliance with corporate standards and government/industry regulations.
Maintain up-to-date working knowledge and adherence of all applicable prevailing guidance, regulation, and law that mandates the nature in which pharmaceutical organizations function including but not limited to FDA, OIG, DDMAC/OPDP,PhRMA,ICMJE,ISPOR).
Review, approve and supervise all aspects of US phase 3B - 4 clinical study programs, including preparation of study protocols, case report forms, study reports, statistical analysis plans, clinical trial guidelines and the accurate and timely reporting of study data.
Oversee conduct of all clinical studies in adherence to both Company standards, and government/industry regulations (GCP/ICH).
Lead the review and approval of U.S. IST (Investigator Sponsored Trial) concepts/protocols according to applicable SOP(s).
Develop and maintain close professional relationships with Key Thought Leaders (physicians and researchers) within pertinent medical community.
Fosters the establishment and maintenance of external scientific advisory boards and assists in advocacy development (in conjunction with RML).
Remain informed of current developments within pertinent medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, professional associations, etc.
Supporting HEOR, Access, and Payer Activities as a Medical Lead.
8-10 years. Relevant experience in Medical Affairs. MD/DO preferred. Doctorate (PhD., Pharm. D. or advanced degree) with relevant experience.
Area of specialization: Immunology (preference for Dermatology & Respiratory).
Excellent communication and presentation skills with the ability to present scientific data in a credible manner. Able to interface professionally with a wide spectrum of internal and external academicians, agencies, and industry executives in the scientific/medical arena.
Strong understanding of the pharmaceutical/biotech drug development and commercialization process.
Leadership skills; personal style that includes a sense of urgency, as well as flexibility and ability to respond to rapidly changing environments and circumstances.
Collaborative and proactive, with a hands-on, roll-up-the sleeves style and attitude.
Highest integrity; committed to ethics and scientific standards.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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