Senior Clinical Research Director, I&I

Sanofi•Cambridge, MA

20h•Onsite

About The Position

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.

Requirements

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)

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).
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

Benefits

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.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume