Executive Director, Clinical Development Lead
modernaSomerville, MA
Executive Director, Clinical Development Lead
modernaSomerville, MA
yesterday
Occupations
Natural Sciences ManagersClinical Research CoordinatorsMedical Scientists, Except EpidemiologistsIndustries
Research and Development in BiotechnologyPharmaceutical Preparation ManufacturingResearch and Development in the Physical, Engineering, and Life SciencesAbout the role
RoleSenior clinical development physician (MD) leading oncology drug development programs at Moderna, with medical responsibility for clinical strategy, study design, protocol writing, and monitoring in the biopharma industry.
Responsibilities:
Develop integrated clinical development plans, optimize study designs aligned with regulatory and commercial goals, generate efficacy and safety evidence, and lead cross-functional collaborations across Research, Regulatory, Clinical Operations, and Commercial teams.
Serve as scientific leader influencing external experts and internal teams, manage risk/benefit assessments, and contribute to regulatory submissions (IND, BLA, MAA).
Oversee technical and strategic aspects of immuno-oncology and mRNA-based therapies, including trial execution, evidence generation, and innovative solutions adoption.
Requirements:
MD with 10+ years in clinical development, at least 5 in industry, with expertise in immuno-oncology or oncology, and experience leading cross-disciplinary teams.
Strong understanding of clinical trial methodology, biostatistics, and regulatory guidelines (FDA, ICH GCP).
Excellent communication, organizational, and problem solving skills.
PreferredExperience with AI/machine learning in drug development.
Regulatory inspections, and global trial conduct.
High-value specificsOncology, immuno-oncology, mRNA therapies.
Clinical development stage from early to late-phase.
Cross-functional leadership.
Work setupIn-office/hybrid model, with emphasis on collaboration.
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JOB OVERVIEW
Experience level
Manager
Location
Somerville, MA
Occupation
Natural Sciences Managers
Industry
Research and Development in Biotechnology
Posted
yesterday
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