Vice President, Clinical Research Endocrinology

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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: Crinetics is seeking an experienced, strategic, dynamic, and innovative Vice President of Endocrinology Clinical Research reporting to the Chief Medical Officer (CMO). The Vice President Clinical Research Endocrinology will be instrumental in further building and developing the Endocrinology Clinical Research function at Crinetics. In collaboration with the executive leadership (CMO), the vice president will serve as a deputy for the CMO and provide support to drive clinical development for Crinetics endocrinology drug candidates and provide clinical guidance to support the discovery of new endocrinology drug candidates. The incumbent will collaborate across the organization to identify, develop, and deliver life-changing therapies to people living with endocrinology disorders and their complications. Essential Job Functions and Responsibilities: These may include but are not limited to: Serve as deputy for CMO on as need basis Plays a key role in the design and implementation of the clinical development strategy across the entire endocrinology portfolio. Leads creation and implementation of innovative trial designs to accelerate delivery of high-quality data to address key scientific questions, including proof-of-concept Provide clinical leadership and lead clinical communication to upper management on trial issues, patient recruitment, investigator's feedback, patient enrollment issues and present a plan of action for resolution of issue Author and/or review clinical documents required for the conduct of clinical studies, including clinical protocols (and amendments), informed consent documents, investigator brochures, and safety management plans in compliance with regulations and good clinical practices Contribute to/lead clinical strategies for successful development of Crinetics endocrine related drug candidates, ensuring alignment with corporate goals and regulatory requirements Serve as the Clinical Research expert to the conception and regular refinement of Target Product Profiles (TPP) Oversee or lead the creation and implementation of a Clinical Development Plan (CDP) for each indication being pursued, using the TPP as a guidance; including coordinating cross-functional collaborations with other departments as needed throughout the asset life cycle; ensure that scenarios and Go/No Go are incorporated into the CDPs Serve as clinical subject matter expert in discussions with external experts and regulatory authorities Engage with Discovery team provide input on selection of future targets. In collaboration with other departments (Biometrics, Clinical Operations, Pharmacovigilance) lead the conception, medical monitoring and medical interpretation of Crinetics endocrinology clinical trials Develop strong external relationships with investigators, research sites, patient advocacy groups and KOLs to design clinical trials that answer important medical questions Contribute to the development of relevant sections of clinical and regulatory documents such as amendments to protocols, briefing books, safety updates, responses to Health Authorities questions and collaborates with Regulatory Affairs in the preparation of regulatory interactions Support/lead the preparation, drafting and finalization of all the clinical sections of all endocrine related products NDA and MAA while incorporating the clinicians' perspective. Lead the timely drafting of clinical responses to questions from regulatory authorities Lead ongoing data review, analysis, and interpretation to understand safety and efficacy profile of the investigational drugs Support business development in identification of new targets and assessment of commercial opportunities Develop and manage departmental budgets that effectively achieve desired goals that are balanced with the financial objectives of the broader clinical research organization Other duties as assigned Education and Experience: Required: MD degree with at least 13 years clinical research experience within a biopharmaceutical company (an equivalent combination of experience and education may be considered) and

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