Vice President, Clinical Research Endocrinology

Role Summary

Vice President of Endocrinology Clinical Research, reporting to the Senior Vice President (SVP). Responsible for building and developing the Endocrinology Clinical Research function, driving clinical development for endocrinology drug candidates, and guiding discovery of new candidates.

Responsibilities

• Serve as deputy for SVP on an as-needed basis
• Design and implement the clinical development strategy across the endocrinology portfolio
• Lead creation and implementation of innovative trial designs to accelerate high-quality data delivery, including proof-of-concept
• Apply hands-on translational medicine/early development experience
• Shape clinical strategies for successful development of Crinetics drug candidates, aligning with regulatory requirements
• Conceive and refine Target Product Profiles (TPP)
• Oversee or lead Clinical Development Plans (CDP) for each indication, coordinating cross-functional collaboration and incorporating Go/No Go decisions
• Act as clinical subject matter expert in discussions with external experts and regulatory authorities
• Lead medical monitoring and interpretation of endocrinology trials in collaboration with Biometrics, Clinical Operations, and Pharmacovigilance
• Develop external relationships with investigators, sites, patient groups, and KOLs to design trials addressing meaningful medical questions
• Contribute to clinical/regulatory documents (protocol amendments, briefing books, safety updates) and collaborate with Regulatory Affairs
• Support/draft clinical sections of NDA/MAA; respond to regulatory questions
• Provide clinical leadership and communicate trial issues to upper management with plans for resolution
• Author/review clinical study documents (protocols, informed consent, investigator brochures, safety plans) per regulations and GCP
• Lead ongoing data review and interpretation to understand safety and efficacy
• Build and lead a team; mentor and develop staff
• Develop and manage departmental budgets aligned with broader CRO objectives
• Other duties as assigned

Qualifications

• MD with at least 13 years of clinical research experience in biopharma; minimum 12 years in leadership roles
• Board certification in internal medicine or related specialty
• Broad internal medicine and clinical pharmacology/translational medicine knowledge
• Experience interacting with FDA/EU regulators; prior regulatory authorization experience preferred
• Translational medicine expertise across Phase 0‚ÄìIV, collaborating with discovery, toxicology, biomarkers, and clinical pharmacology
• Strong knowledge of GCP, ICH guidelines, and regulatory requirements for clinical development
• Experience with medical monitoring of trials and collaboration with Biostatistics, Data Management, and Medical Writing
• Proven leadership skills in a fast-paced, high-accountability environment
• Strong project planning, negotiation, and presentation abilities; capable of creative yet practical problem solving
• Ability to work independently and collaboratively; prioritize tasks to meet timelines
• Strategic thinker and team leader; adaptable to a high-growth, science-driven environment
• Ability to manage multiple workstreams, make decisive decisions, and adapt quickly
• Self-starter with attention to detail and data integrity while maintaining big-picture focus
• Ability to inspire respect across leadership, Board, investors, colleagues, and staff
• Excellent written and verbal communication skills; effective with Board and scientific/medical community
• Highest standards of integrity and ethics in patient care and stewardship of company investments

Education

• MD degree; board certification; significant clinical research leadership experience

Additional Requirements

• Travel up to 20% of your time
• Physical demands are not additional to standard office/clinic duties beyond occasional lifting up to 25 lbs and standard desk-based work