Executive Director, Clinical Science and Clinical Research Operations

Benefits

Additional Information

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 Executive Director, Clinical Science and Clinical Research Operations is a senior executive who sets the strategic direction for clinical science and operational execution across the endocrine clinical development portfolio, from early development through registration. This leader shapes the Clinical Scientist operating model, establishes enterprise-wide standards, and builds organizational capability to deliver programs with excellence and speed. The Executive Director drives alignment across cross-functional teams to anticipate and resolve risks before they impact program timelines or quality. This leader builds and develops a high-performing team-including Clinical Scientists, consultants, and Clinical Research Project Coordinator-setting high standards for quality, rigor, and execution across the portfolio. This role partners with the Executive Medical Director, Clinical Research Endocrinology, to ensure scientific strategy and operational delivery are fully integrated across all endocrine programs. As the operational leader this executive is accountable for the performance, culture, and long-term capability of the Clinical Science team. Essential Job Functions and Responsibilities: These may include but are not limited to: Lead and develop the Clinical Scientist function, including staff, consultants, and Clinical Research Project Coordinator, by building organizational capability, shaping succession pipelines, and driving a high-performance culture aligned with enterprise priorities. Define and evolve the Clinical Scientist operating model, establishing standards, processes, and governance to ensure consistent, scalable execution across all clinical development programs. Serve as the senior leader and decision-maker across Clinical Research and key partner functions (Clinical Operations, Regulatory Affairs, Biostatistics, and Medical Writing), driving alignment on clinical development strategy and resolving cross-functional trade-offs impacting quality, timelines, and risk. Own clinical data oversight, ensuring clean data, analysis, and interpretation to enable high-quality medical decision-making, regulatory submissions, manuscripts, and internal/external presentations. Collaborate with Medical Leads and Medical Monitors on clinical data reviews to identify and investigate events of special interest. Accountable for proactive partnering with Biometrics and Pharmacovigilance in reviewing periodic data listings (adverse events, protocol deviations, concomitant medications, laboratory abnormalities). Establish and oversee a systematic data quality framework across multiple studies, ensuring early signal detection and timely escalation and resolution. Represent the organization externally setting the tone for protocol training and site engagement. Drive the scientific execution of through contribution of key regulatory documents, including IND/CTA/IMPD submissions, protocols and amendments, informed consent forms, clinical study reports, briefing books, safety updates, and responses to Health Authority questions. Set direction for clinical documentation standards, overseeing development of study documents including feasibility questionnaires, study plans, eCRFs, eCRF guidelines, and other trial-specific materials. Oversee DSMB/DMC preparation, ensuring high-quality, data presentations that enable independent safety review and informed stopping rule decisions. Oversee strategic partnerships with CROs, ensuring strong relationships, quality delivery, and alignment with program and company objectives. Lead data cleaning activities through database lock (DBL), coordinating across Clinical Operations, Biometrics, and Medical Monitoring to deliver a complete, query-resolved dataset; provide the Medical Lead with clean, analysis-ready data to support clinical trial decision-making. Lead the development, review, and approval of clinical trial startup materials, serving as a primary owner of startup document quality and timeline; ensure all materials meet regulatory standards and are aligned with program strategy prior to site activ

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