Associate Clinical Research Director

Biopharma Careers

Cambridge (MA)

On-site

USD 173,000 - 249,000

Full time

12 days ago
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Benefits offered by this job

Health benefits
Parental leave (14 weeks)
Global opportunities
Competitive compensation

Job summary

Sanofi Inc. invites an Associate Clinical Research Director to shape and execute clinical development strategies for immunohematology, including sickle cell programs. You will provide medical leadership, design and monitor studies, and collaborate with cross-functional teams to generate high-quality evidence.

The role emphasizes medical rigor, patient safety, and regulatory alignment as you advance programs toward regulatory submissions and product approval.

Qualifications

  • Medical degree (MD) or MD/PhD required; hematology training preferred.
  • Strong clinical development knowledge and regulatory understanding.
  • Experience in clinical research, development, academia, or industry.
  • Excellent communication and cross-functional collaboration skills.

Responsibilities

  • Provide medical expertise and support to clinical lead for immunohematology and sickle cell programs.
  • Contribute to protocol development, feasibility assessments, and risk evaluation.
  • Medical monitoring, data review, and collaboration with study teams and investigators.
  • Support drug product development strategy through lifecycle activities.

Skills

Clinical research leadership
Cross-functional collaboration
Regulatory knowledge
Analytical problem solving

Education

MD or MD/PhD
Hematology training

Job description

Job Title

Associate Clinical Research Director

Location

Cambridge, MA

About the Job

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.

Main Responsibilities
  • The role of the Associate CRD is to 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.
  • He/she will have to 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.
About You
  • Medical degree (MD) or MD/PhD required. Specialty training in a relevant medical discipline required. 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.
  • 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.
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 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.
  • Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
  • Help improve the lives of millions of people globally by making drug development quicker and more effective.
  • Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity andAffirmative 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.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive 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.

US and Puerto Rico Residents Only

North America Applicants Only

The salary range for this position is:

$172,500.00 - $249,166.66

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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