Head of Clinical and Data Sciences
enGene
full-time
Posted on:
Location Type: Hybrid
Location: Boston • Massachusetts • United States
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Salary
💰 $350,000 - $400,000 per year
Job Level
About the role
- Provide scientific leadership across all clinical programs from early development through late‑stage global registrational trials.
- Oversee authorship, development, and strategic review of protocols, IBs, SAPs, CSRs, DSURs, ICFs, eCRFs, and clinical modules of major submissions.
- Lead global regulatory interactions (FDA, EMA, MHRA, PMDA), including briefing docs, written responses, and meeting preparations.
- Direct quantitative strategy across programs, integrating clinical data, real‑world evidence, model‑informed drug development, and exploratory biomarker analyses.
- Ensure robust data quality, oversee scientific data reviews, and resolve complex data issues.
- Lead scientific strategy for regulatory submissions (IND, CTA, BLA, MAA, sBLA/sNDA).
- Drive scientific publication strategy and represent the company in scientific forums.
- Provide leadership to Clinical Scientists, Statisticians, and cross‑functional partners.
Requirements
- Advanced degree required (PhD, PharmD, MD, or equivalent).
- 8+ years industry experience in clinical development, clinical science, or quantitative sciences.
- Significant global submission experience in oncology or urology disease area with direct leadership of key modules. Experience in bladder cancer disease area is preferred.
- Demonstrated leadership in designing and executing complex Phase I–III clinical trials.
- Experience leading scientific interactions with global health authorities.
- Deep understanding of biostatistics, data management, and real‑world data integration.
- Experience building and managing high‑performing scientific and data teams.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical developmentclinical sciencequantitative sciencesbiostatisticsdata managementreal-world data integrationPhase I clinical trialsPhase II clinical trialsPhase III clinical trialsscientific publication strategy
Soft Skills
scientific leadershipstrategic reviewdata quality oversightcomplex problem resolutionteam managementcross-functional collaborationcommunication with global health authoritiesleadership in scientific forumsmentoringstrategic thinking
Certifications
PhDPharmDMD