Job Title: Senior Clinical Scientist
Location: Cambridge, MA
About the job: The Senior Clinical Scientist is a key member of the Rheumatology/Transplant Clinical Development Team, providing medical and scientific support to the Clinical Research Director (CRD). This role encompasses Study Medical Manager responsibilities, spanning clinical trial setup through clinical study report completion, in full compliance with quality and regulatory standards.
Main Responsibilities: Clinical Trials
- Support the design and execution of multiple clinical studies across the development plan
- Help prepare key trial documents - protocols, informed consent forms, and benefit-risk assessments
- Contribute to CRF design and review completion instructions
- Support study start-up, site opening, and enrollment monitoring.
Data & Science:
- Review and analyze data listings, patient profiles, and key study data within statistical reports
- Partner with Data Management to generate relevant queries
- Stay current on competitive data and the therapeutic landscape
- Deliver clinical landscape and benchmark updates to the CRD and Project Lead
Strategy & Development:
- Partner with Clinical Leads and CRDs to build presentations for governance committees
- Serve as delegate for the CRD in developing and overseeing the clinical development plan
Collaboration & Stakeholder Engagement:
- Act as liaison across data management, biostatistics, medical writing, pharmacovigilance, regulatory affairs, clinical operations, and translational medicine
- Support project team members, project management, and medical affairs
- Co-author briefing packages for health authority submissions and contribute to regulatory strategy
- Build and maintain relationships with internal collaborators, KOLs, and investigators
- Support interactions with Sanofi governance bodies, external partners, and committees
About You:Basic Qualifications
Education:- PharmD, PhD or Master's degree in Biomedical Sciences, Pharmacology, Immunology, Molecular Biology, or related field
Experience:- PharmD or PhD holders: minimum 4 years of clinical development experience
- Master's degree holders: minimum 7 years of clinical development experience
- Academic or research experience may be considered
Preferred Qualifications
- Late-stage clinical development experience (Phase 2b/3 preferred)
- Rheumatology or immunology therapeutic area background
- Hands-on experience with clinical trial preparation and execution
- Knowledge of translational medicine and biomarkers
- Strong statistical and data analysis skills
- Proven track record managing complex global projects
- Experience leading cross-functional teams
- Excellent communication and problem-solving abilities
- Regulatory authority interaction experience
The salary range for this position is:
$148.500,00 - $214.500,00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
