Senior Director, PRO-COA COE Lead

🔥 20 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $224k - $280k / year

⏰ Full Time

🟠 Senior

👔 Director

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Crinetics Pharmaceuticals

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2015

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Crinetics Pharmaceuticals is a biotechnology company that develops innovative therapies for endocrine diseases. The company is focused on addressing unmet medical needs by creating treatments for conditions such as acromegaly, carcinoid syndrome, ACTH-dependent Cushing’s syndrome, congenital adrenal hyperplasia, and other endocrine disorders. Crinetics is committed to improving the quality of life for patients through cutting-edge science and robust clinical trials. Their pipeline includes promising candidates like paltusotine, which has been accepted by the U. S. Food and Drug Administration for the treatment of adult patients with acromegaly. The company collaborates with healthcare practitioners and stakeholders to ensure that their therapies address real-life problems effectively and build value for investors by entering market niches with significant needs.

📋 Description

• Own PRO/COA strategy development and execution for Crinetics' pipeline programs • Own the full COA development lifecycle for pipeline programs • Serve as the in-house PRO/COA subject-matter expert and consultant for late-stage assets • Set and maintain PRO/COA methodological and regulatory standards across the function • Partner with Clinical Development and Biometrics on COA endpoint selection • Lead FDA and EMA interactions on outcome measures for pipeline programs • Direct translation and cultural adaptation for global trials and submissions • Lead patient preference and treatment-burden studies for pipeline programs • Contribute PRO/COA evidence to integrated evidence plans • Manage external COA vendors and academic partners while building in-house capability • Provide leadership, career management, coaching, and mentoring as the COE scales

🎯 Requirements

• Advanced degree in a relevant discipline (outcomes research, psychometrics, health services research, public health, epidemiology, or related) • Minimum of 13 years of relevant pharmaceutical, biotech, or consulting experience • Minimum of 10 years of supervisory experience • Minimum of 10 years focused on PRO/COA development • Deep expertise across the COA lifecycle (concept elicitation, content validity, psychometric validation, and meaningful-change/responder analysis) • Demonstrated success developing or qualifying COAs supporting regulatory label claims with FDA and/or EMA • Direct experience leading FDA/EMA interactions on outcome measures • Track record applying COA work across multiple assets or therapeutic areas • Strong knowledge of regulatory and HTA expectations for PRO/COA • Excellent communication and interpersonal skills • Ability to lead, collaborate, and influence cross-functional teams • Flexible and adaptable with scientific rigor

🏖️ Benefits

• Discretionary annual target bonus • Stock options • ESPP • 401k match • Top-notch health insurance plans including medical, dental, vision, and basic life insurance • 20 days of PTO • 10 paid holidays • Winter company shutdown