Development Medical Director leading clinical trials for innovative immunology therapies at Sanofi. Collaborating with global teams to enhance clinical study execution and regulatory documentation.
About the role
- Global Medical Affairs Sr Director responsible for leading strategies for Dupilumab in Eosinophilic Esophagitis. Collaborating with cross-functional teams in a biopharmaceutical company for innovative healthcare solutions.
Responsibilities
- Support the Head of Global Medical Affairs Dupilumab Rhinology and Gastroenterology and collaborate with the other members of the team in the build and execution of Global Med Affairs strategy for EoE.
- Build and execute the Life Cycle management for Dupilumab in EoE; define and prioritize the future needs including new study ideas and tactics to prioritize the best areas for clinical trial investment.
- Collaborate with alliance partners at Regeneron: take a team-oriented approach to making sure strategy is clearly defined and consistent with relevant stakeholders in clinical development and commercial teams.
- Collaborate with R&D and support clinical development programs for alliance assets in Gastroenterology at different stages of development.
- Coordinate data gap analyses across the Regions and countries.
- Contribute to the development and execution of the Integrated Evidence Generation Plan (IEGP).
- Collaborate with the Alliance to execute the data generation activities in alignment with the Brand plan and Global Medical Affairs Plan.
- Guide physician/scientist in charge of the execution of the Life Cycle Management (LCM) and data generation.
- Establish and maintain strong relationships with experts in the Gastroenterology field, academics and professionals medical/scientific organizations and patient associations.
- Lead advisory boards or roundtables and gain strategic insights for medical, scientific, and development strategy.
- Give significant input to publications and co-author relevant abstracts.
- Drive process of data dissemination and ensure that it is publicly presented in an appropriate and timely fashion and in a fair and balanced manner.
- Ensure the scientific integrity of sponsored and supported research, information, and relationships with healthcare providers and patient advocacy groups.
- Ensure a data-driven, patient-centric approach to development of medical strategy both for product and device development as well as possible services which can enhance the value proposition of the product.
- Provide relevant feedback to market access teams to ensure optimal pricing and reimbursement strategy and inclusion of relevant endpoints in clinical trials.
- Travel required, comprising approximately 20-30% of time.
Requirements
- MD, PharmD and/or PhD in Immunology required
- Minimum 5 years’ experience in Academia and/or Industry
- Strong understanding of the pharmaceutical/biotech drug development and commercialization process
- Excellent communication and presentation skills with the ability to present scientific data in a credible manner
- Personal style that includes a sense of urgency, as well as flexibility and ability to respond to rapidly changing environments and circumstances
- Active listening, collaborative and proactive, with a hands-on, roll-up-the sleeves style and attitude
- Highest integrity; committed to ethics and scientific standards
- Able to influence and work on projects in collaboration with our partners and establish excellent working relationships and credibility
- Able to interface professionally with a wide spectrum of internal and external academicians, agencies, and industry executives in the scientific/medical arena.
- MD Board certified (or International Equivalent) in Gastroenterology (GI) or Pediatric GI preferred but not required
- Prior experience in a Global or at least Regional medical affairs role preferred.
- Global experience highly advantageous
- Prior experience in Immunology/Immune inflammation.
- Prior Medical Affairs experience in GI highly advantageous.
- Experience working within an international/global company with a complex organizational environment; able to operate in a matrix team-oriented structure.
Benefits
- high-quality healthcare
- prevention and wellness programs
- at least 14 weeks’ gender-neutral parental leave
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