Vice President, Clinical Research Endocrinology

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

• 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.
• Provides 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.
• 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.
• 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.
• 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.

Required Education and Experience

• MD degree with at least 13 years clinical research experience within a biopharmaceutical company (an equivalent combination of experience and education may be considered)
• A minimum of 12 years in a supervisory/leadership role
• Board certification in internal medicine, or related specialty. Specialty training in adult or pediatric endocrinology preferred.
• Broad understanding and practice of endocrinology- and hands on experience working in clinical pharmacology/translational medicine/early development capacity is required.
• Experience in interacting with the FDA and/or EU regulatory agencies. Previous successful regulatory authorization experience strongly preferred.
• Demonstrated expertise and experience in translational medicine, in close collaboration with discovery, toxicology, biomarkers and clinical pharmacology
• Strong general knowledge of GCP, ICH guidelines and regulatory requirements that apply to clinical drug development
• Intimate knowledge of and high-level expertise in the day-to-day medical monitoring of clinical trials required including past successful working relationships with Biostatistics, Data Management, Medical Writing
• Excellent leadership skills and ability to function effectively in a fast-paced, high accountability environment
• Able to build and lead a strong team with ability to manage, mentor, and develop team is required
• Strong project planning, negotiation, and presentation skills as well as an ability to contribute creative yet practical solutions to problems
• Able to work independently and collaboratively, prioritizing tasks efficiently and meeting clinical and corporate timelines
• Strategic thinker, team leader and individual contributor capable of working in a high growth, dynamic, science-driven environment
• Able to conceive and execute innovative approaches to clinical development
• Able to inspire and earn respect of the leadership team, Board members, the investment community, colleagues, and staff
• Well-developed presentation and written communication skills; effective at Board level, as well as with the scientific/medical community, advisers, and colleagues
• Ethical, with the highest standards of integrity, recognizing that we are the creators of hope for our patients and the health care professionals who serve them as well as stewards of the investments of all our shareholders