Senior Clinical Research Director, I&I

Sanofi•Bridgewater, MA

29d•$225,000 - $375,000

About The Position

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 Senior Clinical Research Director (Sr CRD) is noted as the primary clinical lead for programs . The role requires a well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation, solid analytical skills and the ability deliver to multiple operational tasks. 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 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 Internal Governance: Preparation of Documents and Presentations for Internal Governance Meetings Contribute in the definition of the product value proposition (TVP), TPP and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects Represents his/her project at key regulatory agency meetings as the medical spokesperson for the studies and project Lead the strategy and structure of the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP Supports registrations, label submissions and modifications Take on as necessary the CRD role: Review and/or contribute in the the clinical section of the Investigator’s brochure, CTA, IND, DSUR, INDAR, DRMP, RMP Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for I&I therapeutic area and serves as the clinical advisor to research teams

Requirements

Medical Doctor (MD) preferred: GP or specialist, English fluent (spoken and written)
At least 4 years in pharmaceutical industry or CRO, previous experience in clinical development

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)
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
Raise study or project-level issues to TA Heads, as relevant and shares 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
Preparation of Documents and Presentations for Internal Governance Meetings
Contribute in the definition of the product value proposition (TVP), TPP and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects
Represent his/her project at key regulatory agency meetings as the medical spokesperson for the studies and project
Lead the strategy and structure of the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP
Support registrations, label submissions and modifications
Review and/or contribute in the the clinical section of the Investigator’s brochure, CTA, IND, DSUR, INDAR, DRMP, RMP
Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for I&I therapeutic area and serves as the clinical advisor to research teams

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 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.

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