Medical Director, Clinical Research, Endocrinology

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

Position Summary:

The Medical Director, Clinical Sciences will support the development and execution of Crinetics' endocrinology portfolio as part of a multidisciplinary development team. Responsibilities include contributing to the concise clinical development plan (CCDP), supporting the design and conduct of clinical trials across assigned therapeutic areas, and bringing enthusiasm for Phase 1–3 development, including biomarkers and proof-of-concept. The incumbent will also provide medical and scientific input to publications, support Medical Affairs, and help represent Crinetics to academic, regulatory, and patient organizations.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Partner with the cross-functional team to shape a concise Clinical Development Plan (CCDP) for the indication of interest, building consensus toward Executive Team approval and maintaining the plan over time. Contribute to Strategic Plans and the TPP via focused multidisciplinary internal and external consultation.
• Lead the design, planning and implementation of clinical trials consistent with this CCDP.
• Provide scientific and clinical direction for the development of clinical protocols (and, in early stages, clinical trial outlines [CTOs] and synopses), amendments, and related documents (e.g., informed consent), working with Medical Writing to ensure content accuracy and medical integrity.
• Provide medical monitoring for clinical studies in collaboration with CRO medical monitors.
• Ensure that clinical trials are conducted according to GCP and all applicable regulatory requirements.
• Provide clinical and scientific input to HEOR-led Patient Reported Outcome research across the studies.
• Provide medical and scientific oversight needed to support enrollment feasibility and protocol-driven eligibility.
• Participate in ongoing and formal data analyses and review for CSR completion and planned/actual filing activities.
• Contribute to the development of clinical sections of regulatory documents such as Investigators' Brochures, briefing books, safety updates, IND/BLA submission documents, responses to Health Authorities questions.
• Lead trial-related advisory boards, investigator meetings, protocol training meetings.
• Collaborate with Medical Affairs and Commercial members to develop effective working relationships with key investigators, key opinion leaders and patient advocates to optimize scientific quality/innovation of clinical study design, execution, reporting and publication
• Provide medical/clinical expertise to publications planning and drafting.
• Provide oversight of clinical programs across planning, execution, and completion of clinical trials, ensuring compliance with all applicable regulations and guidance, ICH/GCP, and Crinetics SOPs, in partnership with Clinical Operations.
• Attend conferences and remain current with relevant therapeutic area information.
• Serve as the external clinical "face" of Crinetics in interactions with development partners, and leading clinical discussions at advisory boards, as needed.
• Other duties as assigned.

Education and Experience:

• MD degree with at least 5+ years clinical research experience within industry or academia. Endocrinology subspecialty board certification preferred.
• Equivalent combination of education and applicable job experience may be considered.

• Thorough knowledge of clinical medicine, clinical pharmacology and associated disciplines (e.g., biostatistics, data management, medical writing).
• Deep understanding of strategic and operational aspects of cli