Senior Clinical Scientist
BioSpace · Cambridge, MA · 2 days ago
On-siteAnalystFull-time
Main Responsibilities
- Support the design and execution of multiple clinical studies across the development plan
- Help prepare key trial documents such as 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
- 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
- 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
- Collaborate with stakeholders 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: PharmD, PhD or Master's degree in Biomedical Sciences, Pharmacology, Immunology, Molecular Biology, or related field; 4+ years of clinical development experience for PharmD holders, 7+ years for Master's degree holders; 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