Position Summary
Medical Director, Clinical Sciences will support development and execution of Crinetics’ endocrinology portfolio within a multidisciplinary development team.
Responsibilities
- Partner cross-functionally to shape and maintain a concise Clinical Development Plan (CCDP) toward Executive approval; contribute to Strategic Plans/TPP.
- Lead design, planning, and implementation of clinical trials per the CCDP.
- Provide scientific/clinical direction for protocols (and early CTOs/synopses), amendments, and documents (e.g., informed consent) with Medical Writing.
- Provide medical monitoring with CRO medical monitors; ensure GCP and applicable regulatory compliance.
- Provide scientific input to HEOR-led Patient Reported Outcome research.
- Oversee enrollment feasibility and protocol-driven eligibility.
- Participate in data analyses; support CSR completion and filing activities.
- Contribute to regulatory documents (e.g., Investigators’ Brochures, briefing books, safety updates, IND/BLA materials, responses to Health Authorities).
- Lead advisory boards, investigator meetings, and protocol training.
- Collaborate with Medical Affairs/Commercial to optimize clinical design, execution, reporting, and publication.
- Provide publication expertise; oversee clinical program planning through completion.
- Attend conferences; act as external clinical “face” as needed.
Qualifications
- MD with 5+ years clinical research experience (industry or academia); endocrinology subspecialty board certification preferred.
- Strong knowledge of clinical medicine/pharmacology and related disciplines (biostatistics, data management, medical writing).
- Deep understanding of clinical research/product development strategy and operations.
- Solid knowledge of FDA/EMA, GCP, ICH, and clinical drug development.
- Familiarity with FDA/EU regulatory agency interactions.
- High-level expertise in day-to-day medical monitoring (eligibility, safety review, SAEs).
- Leadership, collaboration/influencing, presentation skills; ethical/integrity.