Medical Director Pulmonary

Job title: Medical Director, Pulmonary

Location: Cambridge, MA / Morristown, NJ

About The Job

Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, you’ll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs.

Our Sanofi Immunology Medical Affairs function serves as a valued strategic partner with Clinical, Commercial, Regulatory, and Market Access on therapeutic solutions to support patients’ needs. The US Medical Immunology team is proud to support Sanofi’s deep commitment to chasing the miracles of science to improve the lives of patients. We shatter treatment inertia through our commitment to leaving no patient behind. We aim to transform medical practice, deliver innovative and actionable data to providers and payers enabling timely patient identification and driving the urgency to act on debilitating immunological disorders.

The Medical Director, Pulmonary functions internally as the product expert to lead the development and execution of the most efficient and integrated US medical/scientific strategy for Pulmonary products, including scientific evidence generation and scientific information exchange with all key stakeholders. As a valued strategic partner with the Medical Field Team, Clinical, Commercial, Regulatory and Market Access this role is essential to success is an outstanding partnership to maximize the value proposition. Externally, the role assists healthcare professionals and payers to optimize patient care and treatment outcomes through evidence-based decisions.

This medical leader is responsible for co-developing the U.S. medical strategy and tactical plan for their entire Therapeutic Area and ensure delivery. This includes a strong partnership with field teams, global teams, alliance management and the relevant U.S. cross-functional partners and ensuring these plans are tailored to the local needs and resources, both on data generation and all aspects of engagement with the scientific community.

Main Responsibilities

• Develop strategy and tactics for an integrated Medical Plan (Medical Education, Medical Communications and Publications, Health Outcomes, Safety, and Clinical Research including Phase IIIB-IV and Investigator Sponsored Trials) and annual budget for assigned the respective therapeutic area products
• Execute the Integrated Medical Plan to ensure on-time and on-budget delivery of all tactical activities and deliverables
• Communicate the details and Progress of the Medical Plan to Management, the Core Team, and all parties responsible for execution
• Provide relevant data evidence to ensure that strategy is clearly defined and consistent with clinical development and commercial strategic objectives
• Support the generation and communication of scientific and medical insights to internal stakeholders, develop/execute strategic and tactical Medical Engagement Plans
• Provide impactful medical strategy and expertise to Clinical, Commercial, Market Access, and Regulatory partners
• 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 the respective therapeutic area products, cultivating a culture of teamwork and collaboration to ensure the delivery of key priorities
• Provide medical leadership and expertise to sales, marketing, legal, and regulatory functions for marketed products and drugs in development
• Pro-actively provide scientific guidance and collaborate with field team, marketing, HEVA, Market Access, and sales teams
• Support the generation and communication of scientific and medical insights to internal stakeholders, develop/execute strategic and tactical Medical Engagement Plans, managing resources and budgets.
• Partner with Field Medical Head, Medical Directors, and other internal partners to manage high-level regional stakeholder relationships, contribute to medical engagement planning, and oversee the tactical budget.
• Collaborate with the health economics team to address questions and opportunities
• Provide medical review and approval of promotional and medical materials in compliance with corporate standards and government/industry regulations
• Review and approve medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs, and Commercial materials
• Provide medical review of applications for independent medical education grants
• Provide medical review of training materials for medical and commercial employees
• Maintain up-to-date working knowledge and adherence of all applicable prevailing guidance, regulation, and law (including but not limited to FDA, OIG, DDMAC/OPDP, PhRMA, ICMJE, ISPOR)
• Support the execution of US Phase IIIB-IV clinical study programs, including preparation of study protocols, case report forms, study reports, statistical analysis plans, clinical trial guidelines, and 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)
• Review and approve IST (Investigator Sponsored Trial) concepts/protocols according to applicable SOPs
• Identify and co-create research collaboration opportunities within the respective therapeutic area to address