Associate Clinical Research Director

Sanofi•Cambridge, MA

5d•$172,500 - $249,167•Onsite

About The Position

Join the engine of Sanofi's mission, where scientific innovation, medical expertise, and patient-focused research come together to advance transformative therapies. In R&D, you will play a key role in shaping and executing clinical development strategies that contribute to bringing innovative medicines to patients worldwide. The role of the Associate Clinical Research Director of immunohematology is to provide medical expertise and/or support to clinical lead for: the clinical studies (Sickle cell disease development program). Serving as a key medical expert within cross-functional teams, the role supports the design, planning, execution, and interpretation of clinical studies while ensuring scientific rigor, medical relevance, and patient safety. Working in close partnership with Clinical Research Directors, Clinical Leads, Clinical Study Units, investigators, and other internal and external stakeholders, the Associate Clinical Research Director contributes to clinical development strategy and supports critical study activities, including protocol and synopsis development, feasibility assessments, medical monitoring, clinical data review, risk assessment, and site engagement. The role acts as a trusted medical advisor within study teams and helps drive the generation of high-quality clinical evidence to support regulatory submissions and successful product development. Through strong scientific expertise, collaborative leadership, and operational excellence, the Clinical Research Assistant Director contributes to the advancement of innovative therapies from clinical development through regulatory approval, with the ultimate goal of improving outcomes for patients.

Requirements

Medical degree (MD) or MD/PhD required.
Specialty training in a relevant medical discipline required.
Minimum of 3 years of relevant experience in clinical research, clinical development, academia, healthcare, biotechnology, pharmaceutical industry, regulatory agencies, or a related environment.
Solid understanding of clinical development and drug development processes, including protocol development, study conduct, and clinical data interpretation.
Ability to interpret complex scientific, clinical, and disease pathway data and translate findings into clinical development insights and strategies.
Working knowledge of Good Clinical Practice (GCP), clinical research methodology, and applicable regulatory requirements.
Strong analytical and problem-solving skills, with the ability to assess risks and support evidence-based decision-making.
Excellent communication, presentation, and collaboration skills, with the ability to work effectively in cross-functional and matrixed environments and engage internal and external stakeholders.

Nice To Haves

Hematology training and/or clinical experience is highly preferred but not required.
Clinical expertise and experience in Sickle Cell Disease or related hematologic disorders strongly preferred.

Responsibilities

Provide medical expertise and/or support to clinical lead for the clinical studies (immunohematology Sickle cell disease development program).
Support other clinical development activities (e.g. pre-assessment and cluster feasibility, medical review and validation of clinical data, study risk assessment and clinical study sites engagement).
Contribute to the Extended synopsis and Protocol for their project.
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.
Support the study CRD as the medical reference in the Clinical Study team, ensuring the medical relevance of clinical data.
Interact with Clinical Leads and other CRDs from the team.
Contributes to drug product development strategy and oversees implementation and execution of drug product development until product approval by health authorities.
Contributes and leads medical operations across the lifecycle of R&D clinical studies or programs (i.e., protocol development, set-up, start-up, conduct, closure, and publication) with the objective of efficiently delivering high quality, cost-effective, conclusive studies, through close collaboration with internal and external stakeholders and clinical studies PIs.