Sanofi
Senior Clinical Research Director, I&I
The Senior Clinical Research Director mentors other CRDs and Clinical Scientists, collaborates across functions to harmonize operational approaches, and leads consensus-building to resolve project-related study issues. The role provides medical expertise to clinical studies and registries, supports clinical development activities, contributes to submission dossiers, and acts as the medical reference within clinical study teams.
Key Responsibilities
- • 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)
- • Within a project, ensure leadership, build consensus, coordinate action plans with other CRDs and stakeholders to resolve project-related study issues
- • Anticipate potential issues (sharing lessons learned) across the project or study teams
- • Raise study or project-level issues to TA Heads, as relevant and share relevant information within and beyond Project teams
- • 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
Required
- • 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)
- • 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
Benefits & Perks
- • 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 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.
Job Title: Senior Clinical Research Director
Location: Cambridge, MA, Morristown, NJ
About The Job
Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
About Sanofi
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s 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 people’s lives.
Main Responsibilities
The role of the Senior CRD is to:
About You
#GD-SA
#vhd
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.
Location: Cambridge, MA, Morristown, NJ
About The Job
Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.
About Sanofi
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s 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 people’s 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
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
- 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)
- 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 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.
#GD-SA
#vhd
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.
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