US Medical Director, Dupilumab Atopic Dermatitis

Role Summary

US Medical Director, Dupilumab Atopic Dermatitis based in Cambridge, MA or Morristown, NJ. Lead the development and execution of the integrated US medical/scientific strategy, including scientific evidence generation and information exchange with key stakeholders. Provide medical leadership to cross-functional teams and assist healthcare professionals and payers to optimize patient care through evidence-based decisions.

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 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 with the 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 knowledge of applicable guidance, regulation, and law governing pharmaceutical functions (e.g., FDA, OIG, DDMAC/OPDP, PhRMA, ICMJE, ISPOR).
• Oversee conduct of all clinical studies in adherence to company standards and government/industry regulations (GCP/ICH).
• Review and approve IST (Investigator Sponsored Trial) concepts/protocols according to SOPs.
• Partner with U.S. Drug Safety in management of adverse events, post-marketing safety data, and communication of safety signals.
• Develop and maintain relationships with Key Thought Leaders and professional societies to represent Sanofi and strengthen its reputation in the therapeutic area.
• Stay informed of developments in relevant medical and scientific communities through literature review and attendance at meetings and professional associations.
• Identify data gaps to inform and execute an integrated evidence generation plan.
• Provide leadership and strategic direction for interactions and communications with external customers, key organizations, and institutions.

Qualifications

• MD/DO/PharmD or PhD with prior experience in Dermatology or Immunology.
• 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.
• In-depth understanding of conceptualizing, designing, and conducting clinical trials.
• Broad leadership experience with the ability to represent Medical Affairs within the company and to leaders at all levels.
• Demonstrated ability to collaborate with cross-functional teams and influence decision-making in a matrix environment.
• Strong ethical standards and commitment to scientific rigor; ability to operate in a high-integrity culture.
• Ability to inspire confidence and drive decision-making and implementation in a matrix environment.
• Excellent communication skills and ability to build solid relationships with the commercial organization.