Vice President, Clinical Research Endocrinology

Vice President Of Endocrinology Clinical Research

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 Senior Vice President (SVP). 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 (SVP), the vice president will serve as a deputy for the SVP and provide support on a day-to-day basis 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 SVP on an ad 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
• Hands-on experience working in a translational medicine / early development capacity is required
• Contribute to / lead clinical strategies for successful development of Crinetics 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
• 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 NDA and MAA while incorporating the clinicians' perspective. Lead the timely drafting of clinical responses to questions from regulatory authorities
• 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
• Lead ongoing data review, analysis, and interpretation to understand safety and efficacy profile of the investigational drugs
• Build and lead a strong team with ability to manage, mentor, and develop team as required
• 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 :

Physical Demands and Work Environment :

Physical Activities : On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.

Laboratory Activities (if applicable) : Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel : You may be required to travel for up to 20% of your time.

The Anticipated Base Salary Range : $365,000 - $457,000

In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide 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, and a winter company shutdown.

The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.

Equal Opportunity Employer : Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and / or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union