Senior Director, PRO-COA COE Lead

Crinetics is a pharmaceutical company based in San Diego, California, developing therapies for endocrine diseases and tumors. We focus on rigorous innovation and patient‑centric science with an inclusive, dog‑friendly workplace culture.

Senior Director, Head of the PRO/COA Center of Excellence (COE) – leads the patient‑centered outcomes/clinical outcomes assessment function within HEOR/RWE. The role focuses on PRO/COA strategy development and execution for pre‑late‑stage programs, owning the full COA lifecycle and advising late‑stage assets, FDA and EMA interactions, and partnering with Clinical Development, Biometrics, and Regulatory teams.

• Own PRO/COA strategy development and execution exclusively for pre‑late‑stage programs.
• Own the full COA development lifecycle: concept elicitation, instrument selection and development, content validity, cognitive interviewing, psychometric validation, and meaningful‑change/responder analysis.
• Serve as in‑house PRO/COA subject‑matter expert, advising Therapeutic Area Leads on Phase 3 PRO work and real‑world/post‑marketing analytics.
• Set and maintain PRO/COA methodological and regulatory standards across the function – protocol templates, statistical analysis plans, quality benchmarks.
• Partner with Clinical Development and Biometrics on COA endpoint selection, trial integration, and analyses supporting regulatory label claims.
• Lead FDA and EMA interactions on outcome measures, including COA qualification, content‑validity evidence, and label‑claim language.
• Direct translation and cultural adaptation for global trials and submissions.
• Lead patient preference and treatment‑burden studies to inform differentiation strategy.
• Contribute PRO/COA evidence to integrated evidence plans, value dossiers, and HTA submissions.
• Manage external COA vendors, instrument licensors, and academic partners while building in‑house capability.
• Provide leadership, career management, coaching, and mentoring as the COE scales; recruit and develop top COA talent.
• Represent Crinetics PRO/COA at scientific congresses (e.g., ISPOR, ISOQOL) and stay current with evolving COA regulatory guidance.
• Ensure compliance with corporate policies and U.S. healthcare laws governing patient data and evidence generation.
• Other duties as assigned.

• Advanced degree (PhD, PharmD, MD, MPH, MSc) in outcomes research, psychometrics, health services research, public health, epidemiology, or related discipline.
• Minimum 13 years of relevant pharmaceutical, biotech, or consulting experience.
• Minimum 10years of supervisory experience.
• Minimum 10years focused on PRO/COA development.
• Deep expertise across the COA lifecycle, with demonstrated success in developing or qualifying COAs for regulatory label claims.
• Experience leading FDA/EMA interactions on outcome measures (e.g., COA qualification, TypeC meetings).
• Track record applying COA work across multiple assets or therapeutic areas, including denovo instrument development.
• Strong knowledge of regulatory and HTA expectations for PRO/COA (FDA guidance, EMA, ISOQOL, ISPOR).
• Excellent communication, influence, and cross‑functional collaboration skills.
• Ability to lead, collaborate, and influence senior leaders across functions and geographies.
• Ensure compliance with corporate policies and U.S. healthcare laws and regulations.
• Flexible, adaptable, and able to operate effectively in ambiguity; balance scientific rigor with execution detail.

• Biotech or commercial‑stage pharma experience in rare or specialty endocrine, oncology, or other niche‑population areas.
• Experience developing pediatric COAs and observer‑reported outcomes.
• Familiarity with European and ex‑U.S. COA evidence requirements.
• Experience integrating ePRO and modern data‑collection platforms.

• Continuous monitoring of a desk; intermittent telephone and keyboard use.
• Some walking and lifting up to 25lb.
• Low to moderate noise level.
• Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Up to 5% of time may be…