US Medical Director, Dupilumab Atopic Dermatitis

Role Summary

US Medical Director, Dupilumab Atopic Dermatitis, based in Cambridge, MA (preferred) or Morristown, NJ. Reports to the Head of US Medical Affairs, Dermatology. Lead the development and execution of an integrated US medical/scientific strategy, including evidence generation and scientific information exchange with key stakeholders. Partner with the field medical team, Clinical Development, and Commercial to maximize value; externally, support health care professionals and payers to optimize patient care and treatment outcomes 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).
• Execution of 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 including FDA, OIG, DDMAC/OPDP, PhRMA, ICMJE, and ISPOR.
• Oversee conduct of all clinical studies in adherence to Company standards and GCP/ICH regulations.
• 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 the communication of identified safety signals.
• Develop and maintain close professional relationships with Key Thought Leaders and relevant professional societies within the medical community to represent Sanofi and strengthen its reputation in the therapeutic area.
• Remain informed of current developments in the medical and scientific communities through literature review, meetings, conventions, 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.
• Preferred: At least 5 years of industry experience in Medical Affairs/Clinical Development, including significant experience in Dermatology.
• Sound scientific and clinical judgment with understanding of the scientific method and clinical applications.
• In-depth understanding of and successful experience in conceptualizing, designing, and conducting clinical trials.
• Broad and formal leadership experience and ability to represent Medical Affairs within the company and to leaders at every level.
• Demonstrated ability to collaborate with cross-functional teams and influence decision making in a matrix environment.
• Commitment to high ethical standards and to exceeding goals and objectives.
• Ability to inspire confidence and operate effectively in a matrix environment; consensus-building and implementation skills.
• Ability to communicate scientific and medical data to internal and external stakeholders.
• Excellent communication skills and ability to build relationships with the commercial organization.

Skills

• Strong interpersonal skills with the ability to influence others.
• Problem-solving with sound judgment and balanced, realistic understanding of issues.
• Team player capable of collaborating with internal and external colleagues.
• Excellent oral and written communication skills, including strong presentation skills.
• High integrity; committed to ethics and scientific standards.
• Strong analytical skills and comfort with ambiguity.
• Ability to work with diverse cultures and stakeholders.
• Ability to manage multiple priorities and projects, with strong prioritization and expectation management.
• Lifelong learner who seeks opportunities to learn.