US Medical Director, Dupilumab Atopic Dermatitis

Role Summary

The US Medical Director for Dupilumab Atopic Dermatitis leads the development and execution of an integrated US medical/scientific strategy, including evidence generation and scientific information exchange with key stakeholders. The role functions as the product expert and collaborates with field medical, clinical development, and commercial teams to maximize value and ensure safe, appropriate use of the brand. External engagement focuses on supporting healthcare professionals and payers with evidence-based decision-making.

Responsibilities

• Support 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).
• Execute 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 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. Partner effectively with commercial organization to develop appropriate and scientifically rigorous promotional material.
• Provide medical and scientific review and approval of promotional material and medical materials in compliance with corporate standards and government/industry regulations.
• 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 that mandates the nature in which pharmaceutical organizations function including but not limited to FDA, OIG, DDMAC/OPDP, PhRMA, ICMJE, ISPOR.
• Oversee conduct of all clinical studies in adherence to both Company standards, and government/industry regulations (GCP/ICH).
• Review and approval of IST (Investigator Sponsored Trial) concepts/protocols according to applicable SOP(s).
• Partner with U.S. Drug Safety in the management of clinical trial adverse events, post-marketing safety data, and in the communication of identified safety signals.
• Develop and maintain close professional relationships with Key Thought Leaders (physicians and researchers) and relevant professional societies within pertinent medical community to represent Sanofi and strengthen its reputation in the therapeutic area.
• Remain informed of current developments within pertinent medical and scientific communities through familiarity with current literature, attendance at meetings, conventions, professional associations, etc.
• Identify data gaps to inform and execute integrated evidence generation plan.
• Provide leadership and strategic direction for interactions and communications with external customers, key organizations, and institutions.

Education

• MD/DO/PharmD or PhD with prior experience in Dermatology or Immunology
• Preference for advanced degree with relevant clinical or scientific focus

Qualifications

• At least 5 years of industry experience in Medical Affairs/Clinical Development, including significant experience in Dermatology
• Sound scientific and clinical judgment with deep understanding of the scientific method and clinical applications
• Proven ability to conceptualize, design, and conduct clinical trials
• Formal leadership experience and strong ability to represent Medical Affairs within the company and to external stakeholders
• Ability to collaborate across functions and influence decision-making in a matrix environment
• Strong ethical standards, high integrity, and commitment to scientific rigor
• Ability to inspire confidence and drive decision-making and implementation in a consensus-building role
• Excellent communication and presentation skills; ability to build effective relationships with the commercial organization
• Proven capacity to organize and lead expert Clinical Research Advisory Panels
• Ability to communicate scientific and medical data to internal and external stakeholders