Jobs · Analyst · Massachusetts

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

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