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Sanofi Group Clinical Research Director, I&I in Cambridge, Massachusetts

About the Job

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

The Clinical Research Director (CRD) is noted as the primary clinical expert for programs . The role requires a well-organized, strategic and operationally focused, resourceful individual with very good emotional intelligence, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks.

Key responsibilities include:

  • Collaborate with other CRDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams

  • Raise study issues to the clinical lead

  • Collaborate with external partners, regulators, and diverse internal stakeholders and collaborators

  • Evaluates relevant medical literature and status from competitive products

  • Review and/or contribute in the the clinical section of the Investigator’s brochure, CTA, IND, DSUR, INDAR, DRMP, RMP

  • Contribute in the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIPContribute to the clinical part of submission dossier for their projects: Common Technical Document for FDA & EMA submission, filing in Japan and China and answers to questions from health authorities

  • Ensures clinical data meets all necessary regulatory standards

  • Participates in Advisory Committee preparation

Experience

  • Robust Scientific and medical/clinical expertise

  • Expertise in clinical development and methodology of clinical studies

  • Very good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies

  • Demonstrated capability to challenge decision and status quo with a risk-management approach

Minimum Level of any Required Qualifications:

  • Medical Doctor (MD): trained in allergy and/or immunology and/or dermatology and/or pulmonolo

  • English fluent (spoken and written)

  • Experience in clinical trials (industry or academia as PI)

  • Computer skills

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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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