Crinetics Pharmaceuticals · 1 week ago
Vice President, Clinical Research Endocrinology
Crinetics Pharmaceuticals is a pharmaceutical company focused on developing therapies for endocrine diseases. They are seeking a Vice President of Endocrinology Clinical Research to lead and develop their clinical research function, collaborating with executive leadership to drive clinical development for endocrinology drug candidates.
BiotechnologyHealth CarePharmaceuticalTherapeutics
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
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
Qualification
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 a minimum of 12 years in a supervisory/leadership role
Board certification in internal medicine, or related specialty
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
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
Ability 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
Ability 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 prioritize and parallel process multiple workstreams, comfortable 'changing gears' and remaining flexible, as well as making definitive decisions
Self-starter, who enjoys rolling up their sleeves and digging into the details; rigorous attention to details and data, while not losing sight of the bigger picture
Able to conceive and execute innovative approaches to clinical development
Ability 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
Preferred
Specialty training in adult or pediatric endocrinology
Benefits
Discretionary annual target bonus
Stock options
ESPP
401k match
Top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
20 days of PTO
10 paid holidays
Winter company shutdown
Company
Crinetics Pharmaceuticals
Crinetics is a clinical-stage pharmaceutical company that develops therapies for people with rare endocrine diseases.
Funding
Current Stage
Public CompanyTotal Funding
$2BKey Investors
Frazier Healthcare PartnersNational Institutes of HealthPerceptive Advisors
2026-01-06Post Ipo Equity· $349.22M
2024-10-08Post Ipo Equity· $500M
2024-02-28Post Ipo Equity· $350M
Recent News
BioWorld Financial Watch
2026-01-15
2026-01-07
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