Sr Director, Clinical Development (MD)
Core
Provide clinical oversight and medical monitoring to one or more clinical trials for CAR T-cell cancer therapies, guiding project teams to design and implement high-quality, time and cost-effective clinical studies.
Role type
Senior Medical Director (MD/DO)
Builds
Clinical trials for personalized CAR T-cell therapies
Domain
Biopharmaceuticals / Oncology / Cell Therapy
Required skills
Clinical trial design and implementation, Protocol writing, Investigator meeting leadership, Regulatory filing support (BLA/MAA/IND), Strategic planning, Cross-functional collaboration, Scientific publication authoring
Preferred skills
Board certification in neurology, Phase 1-3 trial management, Neurological disease drug development, Proof-of-concept and first-in-human study experience, Strategic leadership
Technologies
Clinical trial management systems, Regulatory databases
Responsibilities
Provide clinical oversight and medical monitoring to one or more clinical trials; Lead project teams to design and implement clinical studies; Write protocols, investigator brochures, and clinical study reports; Conduct investigator meetings and lead site initiation visits; Provide clinical expertise for regulatory filings and respond to regulatory authority questions; Translate research findings into clinical development opportunities; Present scientific information at conferences and author publications.
Seniority
Senior, hands-on IC with strategic leadership