Medical Director, U.S. Immunology

Role Overview

• 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 key questions in the delivery of patient care
• Identify needs for post-marketing clinical trials and registries and oversee their management and execution
• Ensure that all data generated by the company or investigator-sponsored trials are publicly presented in an appropriate and timely fashion and in a fair and balanced manner
• Partner with US Drug Safety in the management of clinical trial adverse events, post-marketing safety data, and in the communication of identified safety signals
• Identify and communicate Product Alerts to the Core Team (in conjunction with US Drug Safety, USRAMP, GMA)
• Develop and maintain close professional relationships with Key Thought Leaders (physicians and researchers) within the respective therapeutic area medical and scientific community
• Lead medical and scientific advisory board discussions to identify and elevate medically focused opportunities, resources, and strategic action within >
• Foster the establishment and maintenance of external scientific advisory boards and assist in advocacy development
• Interact with experts at medical meetings, advisory boards, and outreach meetings to represent Sanofi and strengthen its reputation in the therapeutic area
• Provide disease state and product training to internal and external stakeholders
• Remain informed of current developments within the respective therapeutic area medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, and professional associations
• Performs other duties as assigned.

Requirements

• Advance degree in life sciences or pharmaceutical sciences (PhD, PharmD, PA, NP or MD with relevant experience)
• Minimum 5 years of relevant experience in Medical Affairs
• Strong track record in developing and executing medical strategies in the US
• Clinical or medical affairs experience in areas related to Immunology strongly preferred
• Industry experience in Medical Affairs and/or Clinical Development, with significant experience in Medical Affairs Launch and Life Cycle Management activities
• High degree of knowledge of relevant healthcare systems, the evolving medical landscape, regulatory and payer environment, public health and industry trends to accurately identify key issues and develop strategies
• Sound scientific and clinical judgment, including an in-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale
• In-depth understanding of how to conceptualize, design, and conduct clinical trials.
• Experience in clinical trial design and execution preferred
• Ability to disrupt status quo with innovation while remaining pragmatic and focused on priorities; ability to translate innovative strategies or solutions into actionable plans.

Tech Stack

• Google Cloud Platform

Benefits

• high-quality healthcare
• prevention and wellness programs
• at least 14 weeks’ gender-neutral parental leave