Medical Director – RSV Franchise – Vaccines

Medical Director – RSV Franchise – Vaccines

Requirements

• Advanced degree (M.D.) in scientific or healthcare related field (vaccinology, immunology, microbiology infectious disease or related field of study)
• 5+ years in Medical Affairs within the pharmaceutical / biotechnology industry
• Relevant clinical experience or track record of peer reviewed publications in the US
• Ability to travel up to 20% of the time
• Knowledge of US health care system, communicable disease control, public health, and immunization practices

Responsibilities

• Act as a cross-functional partner to provide support within the US Medical team and work in close partnership with other departments including brand teams and Public Affairs
• Play a leadership role in developing, executing, and contributing to the Country Medical Roadmap (CMR) through close collaboration with the Franchise Medical Head as well as demonstrating active involvement in the annual cross-functional brand planning process
• Ensure alignment of the US medical strategy with the Global medical strategy through co-creation within the global medical team
• Play a leadership role in shaping medical strategy at global, regional, and local levels, ensuring alignment with US Medical strategic objectives, while monitoring publications outlined in the CMP and determining appropriate dissemination to targeted external stakeholders through collaboration with the Franchise Advisor, External Scientific Exchange, and other key personnel, as well as contributing to congresses, publications, and NITAG engagements
• Act as the country Medical expert for the Integrated Evidence Generation Plan (iEGP), providing strategic guidance and serving as the key liaison between global Medical, the Principal Investigator (PI), and the US Medical Team on Sanofi-sponsored studies, as delegated by the Franchise Medical Head
• Identify, establish, build, grow, and maintain strategic relationships with senior experts, key opinion leaders (KOLs), professional societies, immunization advisory bodies, patient advocacy groups, decision makers and other external stakeholders, acting as SME and fostering scientific engagement to strengthen their understanding of our products and to collaborate on high-priority global studies and scientific initiatives
• Provide external scientific education on disease states, epidemiology, and clinical trials of [franchise] product(s), support company positions, and provide guidance on company products and related medical issues
• Evaluate Medical educational grant requests stringently in accordance with internal operating procedures and aligned to Country Medical Plan (CMP)
• Lead external advisory boards organized to support the medical strategic objectives and/or medical plan
• Provide significant scientific expertise within and outside the [franchise] team
• Work with cross-functional internal stakeholders, in particular field medical, to development strategic imperatives and downstream strategies and tactics to support our goals
• Provide training to field-based medical team on all current and new publications and related assets in collaboration with NA Training Lead
• Provide medical guidance to internal Sanofi customers, including contribution of medical information and clinical trial data for pharmacovigilance (PV) and regulatory reports to the US FDA and other health authorities
• Collaborate with marketing teams to link sound evidence to brand strategy
• Represent as country medical expert in all product label updates and product Company Core Datasheet (CCDS) updates
• Work with R&D and Clinical Development teams to provide medical input to the design and support the execution of company-sponsored clinical trials (i.e., Ph 4 post-marketing and observational studies) for new products that may join franchise portfolio in accordance with integrated evidence generation plans (iEGP)
• Partner with R&D and Clinical Development teams to write, review, edit, and approve key regulatory documents
• Engage Key External Leaders (KOLs) to apply for support for ISSs that are aligned with Life Cycle Management and Global Brand Team (GBT) strategies
• Liaise with Medical Study Leader to oversee investigator-initiated study (IIS) process from end to end including: Reviewing ISS and ESC applications, liaise with the investigators of study applications, present studies to the GMT and SRC, follow study progress to completion including eventual publication
• Participate as subject matter expert on multi-disciplinary Review Committee (RC) meetings for medical review and approval of all materials and messaging intended for external use
• Contribute to the development and management of specifically owned franchise budget line items by tracking expenditures and executing plans in a cost-effective manner in collaboration with the Franchise Medical Strategy Planner
• Contribute to the development and management of specifically owned franchise budget line items by tracking expenditures and executing plans in a cost-effective manner in collaboration with the Franchise Medical Strategy Planner

Preferred Qualifications

• Prior experience in an external stakeholder facing role (i.e., governmental collaboration)
• Recognized by other vaccine experts as being expert in vaccinology or a related discipline
• Infectious diseases and/or vaccine experience either from academia/research and/or preferably from the pharma industry with relevant customer knowledge