Vice President, Clinical Research Endocrinology

Role 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, serve as a deputy for the CMO, and drive clinical development for Crinetics endocrinology drug candidates while guiding discovery of new candidates. The role involves collaborating across the organization to identify, develop, and deliver therapies for endocrinology disorders and their complications.

Responsibilities

• Serve as deputy for CMO on an as-needed basis
• Design and implement the clinical development strategy across the entire endocrinology portfolio
• Lead creation and implementation of innovative trial designs to accelerate high-quality data delivery, including proof-of-concept
• Provide clinical leadership and manage clinical communication to upper management on trial issues, recruitment, investigator feedback, enrollment issues, and action plans
• Author and/or review clinical documents for clinical studies, including protocols, informed consent documents, investigator brochures, and safety management plans in compliance with regulations and GCP
• Contribute to/lead clinical strategies for endocrine drug development, aligning with corporate goals and regulatory requirements
• Serve as the Clinical Research expert for Target Product Profiles (TPP) conception and refinement
• Oversee or lead the creation and implementation of Clinical Development Plans (CDP) for each indication, coordinating cross-functional collaborations and incorporating Go/No-Go scenarios
• Act as clinical subject matter expert in discussions with external experts and regulatory authorities
• Engage with Discovery to provide input on future target selection
• Collaborate with Biometric, Clinical Operations, and Pharmacovigilance to lead medical monitoring and interpretation of endocrinology trials
• Develop external relationships with investigators, research sites, patient advocacy groups, and KOLs to design trials addressing important questions
• Contribute to clinical and regulatory documents, including amendments to protocols, briefing books, safety updates, and regulatory interactions in collaboration with Regulatory Affairs
• Support/lead the preparation of clinical sections of NDA/MAA submissions and respond to regulatory questions from authorities
• Lead ongoing data review, analysis, and interpretation of safety and efficacy
• Support business development in identifying new targets and assessing opportunities
• Develop and manage departmental budgets aligned with broader clinical research objectives
• Other duties as assigned

Qualifications

• MD degree with at least 13 years of clinical research experience within a biopharmaceutical company and 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 with hands-on experience in clinical pharmacology/translational medicine/early development
• Experience interacting with the FDA and/or EU regulatory agencies; prior successful regulatory authorization experience strongly preferred
• Demonstrated expertise in translational medicine in collaboration with discovery, toxicology, biomarkers, and clinical pharmacology
• Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical drug development
• Experience in day-to-day medical monitoring of clinical trials and working with Biostatistics, Data Management, and Medical Writing
• Excellent leadership skills and ability to function in a fast-paced, high-accountability environment
• Ability to build and lead a strong team; experience in mentoring and developing staff
• Strong project planning, negotiation, and presentation skills with creative yet practical problem-solving abilities
• Ability to work independently and collaboratively, prioritizing tasks to meet timelines
• Strategic thinker and team leader who can contribute as both a leader and individual contributor
• Ability to manage multiple workstreams, adapt to changes, and make definitive decisions
• Self-starter with meticulous attention to detail and data integrity while maintaining focus on the big picture
• Ability to conceive and execute innovative clinical development approaches
• Ability to inspire and earn respect of leadership, boards, investors, colleagues, and staff
• Strong presentation and written communication skills; effective at board level and with scientific/medical communities
• Ethical with high integrity, serving as a steward of patient care and shareholder investments
• Preference for specialty training in adult or pediatric endocrinology

Additional Requirements

• Travel up to 20% of time may be required