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Medical Director, Dermatology

Sanofi
2 months ago
Remote friendly (Morristown, NJ)
United States
Medical Affairs
Main Responsibilities
- Develop strategy and tactics for an integrated Medical Plan (Medical Science Liaisons, Medical Education, Medical Communications and Publications, Health Outcomes, Safety, and Clinical Research incl. Phase IIIB–IV and Investigator Sponsored Trials) and annual budget for assigned Dermatology products.
- Execute the Integrated Medical Plan to deliver tactical activities and deliverables on time and on budget.
- Communicate Medical Plan details and progress to Management, the Core Team, and other execution stakeholders.
- Provide evidence/data to ensure strategy aligns with clinical development and commercial strategic objectives.
- Generate and communicate scientific/medical insights; develop and execute Medical Engagement Plans.
- Provide medical strategy and expertise to Clinical, Commercial, Market Access, and Regulatory partners.
- Ensure cross-functional alignment to support safe and appropriate use of Dermatology products.
- Provide medical leadership for sales, marketing, legal, and regulatory functions for marketed products and drugs in development.
- Guide and collaborate with field team, marketing, HEVA, Market Access, and sales.
- Manage MSL resources and budgets; partner with Field Medical Head and Medical Directors on regional stakeholder relationships and medical engagement planning.
- Collaborate with Health Economics to address questions and opportunities.
- Provide medical review/approval of promotional and medical materials to ensure compliance with applicable standards and regulations.
- Review and approve medical/scientific content in Regulatory, Safety, Scientific Affairs, Medical Affairs, and Commercial materials.
- Review medical content for independent medical education grant applications.
- Review and approve training materials for medical and commercial employees.
- Maintain knowledge and adherence to prevailing guidance, regulations, and laws (e.g., FDA, OIG, DDMAC/OPDP, PhRMA, ICMJE, ISPOR).
- Support US Phase IIIB–IV clinical study programs (protocols, CRFs, reports, SAPs, guidelines, timely and accurate reporting).
- Oversee clinical study conduct per GCP/ICH and applicable standards.
- Review/approve Investigator Sponsored Trial (IST) concepts/protocols per SOPs.
- Identify/co-create research collaborations; assess needs for post-marketing trials/registries and oversee execution.
- Ensure company/investigator-sponsored trial data are publicly presented appropriately and in a fair/balanced manner.
- Partner with US Drug Safety on adverse events, post-marketing safety, and communication of safety signals.
- Identify and communicate Product Alerts to the Core Team (with US Drug Safety, USRAMP, GMA).
- Build relationships with Key Thought Leaders; lead medical/scientific advisory board discussions and foster external advisory boards.
- Represent the company at medical meetings and provide disease-state/product training to internal and external stakeholders.
- Stay current on Dermatology medical/scientific developments via literature and professional activities.

Qualifications
- Advance degree in life sciences/pharmaceutical sciences (PhD, PharmD, PA, NP, or MD with relevant experience).
- Minimum 5 years of relevant Medical Affairs experience.
- Strong track record developing and executing US medical strategies.
- Clinical or medical affairs experience in Dermatology and/or Immunology strongly preferred.
- Industry experience in Medical Affairs and/or Clinical Development, including Medical Affairs Launch and Life Cycle Management.

Skills/Knowledge (Required/Preferred)
- Deep knowledge of healthcare systems, regulatory/payer environment, and public health/industry trends.
- Strong scientific and clinical judgment; in-depth understanding of clinical applications of the scientific method.
- Ability to conceptualize/design/conduct clinical trials (trial design/execution experience preferred).
- Ability to translate innovative strategies into actionable plans; pragmatic, priority-focused.
- Effective internal/external stakeholder management and cross-functional leadership in a matrix environment.
- Ability to communicate scientific/medical data to internal and external stakeholders.
- Knowledge of pharmacovigilance and local regulatory process; change management (Change Champion mindset).
- Digital literacy.

Benefits (explicitly stated)
- Health and wellbeing benefits, including high-quality healthcare and prevention/wellness programs.
- At least 14 weeks’ gender-neutral parental leave.

Application instructions
- Not specified in the provided text.