Clinical Research Director

Job Title: Clinical Research Director
Location: Cambridge, MA

Join Sanofi’s R&D team where deep immunoscience meets AI‑powered research. As Clinical Research Director you will lead clinical development activities for R&D programs, coordinate with cross‑functional teams, and provide scientific and regulatory expertise to drive breakthrough therapies.

• Lead the development of clinical plans and integrated development plans (IDP) for assigned projects.
• Collaborate with Development Medical Directors (DMDs), Development Scientific Directors (DSDs), and other stakeholders to deliver clinical strategy and regulatory interactions.
• Develop and maintain study‑level regulatory documents, including abbreviated protocols, full protocols, amendments, and informed consent forms.
• Oversee study start‑up activities such as pressure testing, competitive intelligence, patient engagement, feasibility, and risk assessment.
• Provide clinical scientific input for all study conduct activities: IRB/HA queries, protocol training, data review, and safety monitoring.
• Support regulatory submissions (CTA, IND, BLA, CTD, etc.) and contribute to the Common Technical Document.
• Lead and support clinical study committees (IDMC, steering, adjudication) and contribute to statistical analysis plans and data validation.
• Generate key study documents: investigator’s brochure, regulatory submissions, briefing packages, and presentation materials.
• Engage with external partners, regulators, and scientific experts to advance project objectives.
• Participate in manuscript writing, abstract preparation, and advisory board collaborations.

• Medical degree (MD) with specialization in dermatology, allergology, or a general practitioner with dermatology development experience.
• Minimum 3 years of clinical or pharmaceutical industry experience, preferably in atopic dermatitis or hidradenitis suppurativa.
• Strong scientific and clinical expertise in clinical study design and methodology.
• Excellent communication skills and ability to interact across functional and regulatory teams.
• Proven problem‑solving and risk‑management capabilities.
• Ability to negotiate and secure operational resources for clinical conduct.
• Fluency in spoken and written English.
• Teaching and training experience is desirable.
• Comfortable working within a matrix organization and cross‑cultural teams.
• Open minded to digital solutions in clinical development.

• Salary range: $ – $ (commensurate with experience).
• Comprehensive health and wellness benefits, including high‑quality health care and prevention programs.
• At least 14 weeks gender‑neutral parental leave.
• Opportunities for career advancement, international posting, and participation in cutting‑edge research.

Sanofi and its U.S. affiliates are Equal Opportunity employers. All qualified applicants receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, gender identity or expression, sexual orientation, disability, veteran status, or any other characteristic protected by law.