US Medical Director, Dupilumab Atopic Dermatitis in Cambridge

Location: Cambridge, MA / Morristown, NJ

About the Job

Join the team transforming care for people with immune challenges, rare diseases, cancers, and neurological conditions. In Specialty Care, you’ll help deliver breakthrough treatments that bring hope to patients with some of the highest unmet needs. Sanofi is recruiting a Director, US Medical Affairs. The Director will report to the Head of US Medical Affairs, Dermatology. This position is based in Cambridge, MA (preferred) or Morristown, NJ. The role functions internally as the product expert to lead the development and execution of the most efficient and integrated US medical/scientific strategy, including scientific evidence generation and scientific information exchange with all key stakeholders. Essential to success is an outstanding partnership with the field medical team, Clinical Development, and Commercial to maximize the value proposition. Externally, the role assists health care professionals and payers to optimize patient care and treatment outcomes through evidence-based decisions.

Main 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.

About You

The ideal candidate will have the following mix of professional and personable characteristics:

• MD/DO/Pharm D or PhD with prior experience in Dermatology or Immunology.
• At least 5 years of industry experience in Medical Affairs/Clinical Development is preferred, 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 how to conceptualize, design, and conduct 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 and matrix environment.
• Energetic with an absolute commitment to facilitating a culture that operates with high ethical standards and strives to exceed all 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.

Personal Attributes:

• 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.

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.