US Medical Director, Dupilumab Atopic Dermatitis

Role Summary

The US Medical Director, Dupilumab Atopic Dermatitis leads the development and execution of the US medical/scientific strategy for Dupilumab in dermatology/immunology, serving as the product expert. Based in Cambridge, MA (preferred) or Morristown, NJ, the role reports to the Head of US Medical Affairs, Dermatology and partners with field medical, Clinical Development, and Commercial to maximize value and ensure evidence generation and information exchange with key stakeholders. Externally, the role supports health care professionals and payers in making evidence-based decisions to optimize patient care and outcomes.

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 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.

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, including an in-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale.
• In-depth understanding of and proven success in conceptualizing, designing, and conducting clinical trials.
• Broad and formal leadership experience, including excellent leadership presence to represent Medical Affairs within the company, to other functions, and to leaders at every level.
• Demonstrated excellence in collaborating with experts from other functions and influencing decision making without authority in a complex, matrix environment.
• Energetic with an absolute commitment to facilitating a culture that operates with high ethical standards and strives to exceed goals and objectives.
• Demonstrated ability to inspire confidence while working effectively in a matrix environment.
• Comfort operating in a consensus-building role with ability to drive decision-making and implementation.
• Ability to inspire confidence, both internally and externally, in Sanofi Dermatology—leading by example and demonstrating collaborative behavior.
• Demonstrated ability to organize and lead expert Clinical Research Advisory Panels.
• Ability to understand and effectively communicate scientific and medical data to internal and external stakeholders.
• Excellent communication skills with the ability to build solid working relationships with the commercial organization.

Skills

• Strong interpersonal skills with the ability to influence others.
• Excellence in solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues.
• A team player; able to collaborate successfully with both internal and external colleagues.
• Excellent oral and written communication skills, including strong presentation skills.
• The highest personal integrity; committed to ethics and scientific standards.
• Strong analytical skills, comfort managing through ambiguity.
• Understanding and success in dealing with different cultures.
• Ability to manage competing priorities and projects, requiring an excellent ability to prioritize and manage expectations.
• A lifelong learner who consistently seeks opportunities to learn.

Education

• MD/DO/PharmD or PhD (Dermatology or Immunology focus preferred).