Senior Director, PRO-COA COE Lead
Crinetics Pharmaceuticals
June 30, 2026
Remote friendly (United States)
United States
Operations
Responsibilities:
- Own PRO/COA strategy development and execution for pipeline (pre-late-stage) programs; build fit-for-purpose COA strategies.
- Lead full COA lifecycle: concept elicitation; instrument selection/development; content validity; cognitive interviewing; psychometric validation; meaningful-change/responder analysis.
- Serve as PRO/COA SME for late-stage assets; advise Therapeutic Area Leads on Phase 3 PRO endpoints and real-world/post-marketing PRO collection/analytics.
- Set/maintain PRO/COA methodological and regulatory standards (protocol templates, SAPs for COA endpoints, quality benchmarks).
- Partner with Clinical Development and Biometrics on endpoint selection, trial integration, and analyses supporting label claims.
- Lead FDA/EMA interactions for outcome measures (COA qualification, content-validity evidence, label-claim language).
- Ensure cross-country measure equivalence via translation/cultural adaptation; lead patient preference and treatment-burden studies.
- Contribute PRO/COA evidence to integrated evidence plans, value dossiers, and HTA submissions.
- Manage external COA vendors/licensors/academic partners; build in-house capability; recruit/develop COE talent; represent at scientific congresses.
- Ensure compliance with corporate policies and US healthcare laws.
Qualifications (Required):
- Advanced degree (PhD, PharmD, MD, MPH, MSc or equivalent) in outcomes research, psychometrics, health services research, public health, epidemiology, or related.
- 13+ years relevant pharma/biotech/consulting experience.
- 10+ years supervisory experience; 10+ years PRO/COA development.
- Deep COA lifecycle expertise; proven regulatory success (FDA/EMA) and experience leading FDA/EMA outcome-measure interactions.
- Track record across multiple assets/therapeutic areas; strong FDA/EMA/HTA (ISOQOL/ISPOR) knowledge.
- Excellent communication/influence; ability to lead cross-functional teams; flexibility in ambiguity.
Qualifications (Preferred):
- Biotech/commercial-stage experience in rare/specialty endocrine, oncology, or niche populations.
- Pediatric COA and observer-reported outcome experience; ex-US/Europe evidence requirements.
- ePRO and modern data-collection platform experience.
Benefits:
- Discretionary annual target bonus; stock options; ESPP; 401(k) match; medical/dental/vision/basic life insurance; 20 days PTO; 10 paid holidays; winter company shutdown.
Travel:
- Up to 5%.
- Own PRO/COA strategy development and execution for pipeline (pre-late-stage) programs; build fit-for-purpose COA strategies.
- Lead full COA lifecycle: concept elicitation; instrument selection/development; content validity; cognitive interviewing; psychometric validation; meaningful-change/responder analysis.
- Serve as PRO/COA SME for late-stage assets; advise Therapeutic Area Leads on Phase 3 PRO endpoints and real-world/post-marketing PRO collection/analytics.
- Set/maintain PRO/COA methodological and regulatory standards (protocol templates, SAPs for COA endpoints, quality benchmarks).
- Partner with Clinical Development and Biometrics on endpoint selection, trial integration, and analyses supporting label claims.
- Lead FDA/EMA interactions for outcome measures (COA qualification, content-validity evidence, label-claim language).
- Ensure cross-country measure equivalence via translation/cultural adaptation; lead patient preference and treatment-burden studies.
- Contribute PRO/COA evidence to integrated evidence plans, value dossiers, and HTA submissions.
- Manage external COA vendors/licensors/academic partners; build in-house capability; recruit/develop COE talent; represent at scientific congresses.
- Ensure compliance with corporate policies and US healthcare laws.
Qualifications (Required):
- Advanced degree (PhD, PharmD, MD, MPH, MSc or equivalent) in outcomes research, psychometrics, health services research, public health, epidemiology, or related.
- 13+ years relevant pharma/biotech/consulting experience.
- 10+ years supervisory experience; 10+ years PRO/COA development.
- Deep COA lifecycle expertise; proven regulatory success (FDA/EMA) and experience leading FDA/EMA outcome-measure interactions.
- Track record across multiple assets/therapeutic areas; strong FDA/EMA/HTA (ISOQOL/ISPOR) knowledge.
- Excellent communication/influence; ability to lead cross-functional teams; flexibility in ambiguity.
Qualifications (Preferred):
- Biotech/commercial-stage experience in rare/specialty endocrine, oncology, or niche populations.
- Pediatric COA and observer-reported outcome experience; ex-US/Europe evidence requirements.
- ePRO and modern data-collection platform experience.
Benefits:
- Discretionary annual target bonus; stock options; ESPP; 401(k) match; medical/dental/vision/basic life insurance; 20 days PTO; 10 paid holidays; winter company shutdown.
Travel:
- Up to 5%.