Senior Manager, Clinical Scientist, Genetics Medicine
Core
Senior Manager leading clinical strategy and study execution for early-phase genetic medicine development from discovery through Proof of Concept.
Role type
Senior Manager, Clinical Scientist (Genetics Medicine)
Builds
Clinical trial protocols, regulatory submissions, and study reports for genetic medicine programs.
Domain
Biotechnology / Genetics Medicine / Early-Phase Clinical Development
Required skills
Clinical research/development experience, protocol design, regulatory document drafting, medical monitoring, safety trend analysis, risk mitigation, compliance with FDA/EMEA/ICH/GCP
Preferred skills
PhD/PharmD/Master's in biomedical subject, early-phase development experience (First-In-Human, Proof of Concept), training in pharma/biotech or academic/clinical settings
Technologies
None stated
Responsibilities
Represent clinical genetics function on study teams, contribute to clinical study concepts and protocols, draft regulatory and clinical documents, review key study documents, partner with Clinical Trial Managers for clinical input and training, support medical monitoring and safety analysis, organize steering committees and advisory boards, identify and mitigate program risks
Seniority
Senior Manager, hands-on leadership