Senior Clinical Research Director, I&I

Job Title: Senior Clinical Research Director

Location: Cambridge, MA, Morristown, NJ

About The Job

Join the engine of Sanofis mission where deep immunoscience meets bold, AI-powered research. In R&D, youll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi

Were an R&D-driven, AI-powered biopharma company committed to improving peoples lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve peoples lives.

Main Responsibilities

The role of the Senior CRD is to:

• Act as a mentor for other CRDs and Clinical Scientists on a same project/TA
• Collaborate with functions to ensure uniform, aligned operational approach (e.g harmonizing study documents, ES, protocols, etc). As relevant, within a project, ensure leadership, build consensus, coordinate action plans with other CRDs and stakeholders to resolve project-related study issues, anticipates potential issues (sharing lessons learned) across the project or study teams. He/she raises study or project-level issues to TA Heads, as relevant and shares relevant information within and beyond Project teams.
• Take on as necessary the CRD role:
• Provide medical expertise to the clinical studies (except select Exploratory Pharmacology studies) and/or registries (eg: protocol, Key Results, Clinical Study Report)
• Support other clinical development activities (e.g. pressure test and cluster feasibility, medical review and validation of clinical data, study risk assessment)
• Contribute 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
• Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators
• Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data
• Interact with other CRDs in the project, Global Project Head, The PV Rep, Regulatory and other key functional reps
  

Experience

About You

• Understanding of pharmaceutical product development and life cycle management gained through ~4 years of clinical development and medical experience
• Excellent Scientific and medical / clinical expertise
• Excellent expertise in clinical development and methodology of clinical studies
• Excellent 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
• Ability to negotiate to ensure operational resources are available for continued clinical conduct
• Fluency in written and spoken English
• Excellent Teaching skills, demonstrated ability to assist and train others
• Ability to work within a matrix model
• International/ intercultural working skills
• Open-minded to apply new digital solutions
  
  
  

Minimum Level Of Any Required Qualifications

• MD or eqivalent (DO, MBBS)
• Specialization and training as a Rheumotologist
• At least 4 years in pharmaceutical industry or CRO, previous experience in late stage clinical development
• English fluent (spoken and written)
  
  
  

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 its through a promotion or a 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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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.