Senior / Executive Director, Clinical Quality Assurance

Immunome, Inc., an emerging clinical-stage oncology company based in Bothell, Washington, is seeking an experienced Senior/Executive Director of Clinical Quality Assurance to lead comprehensive quality strategies across our growing targeted cancer therapy pipeline.

Position Summary

This is a high-impact leadership role responsible for establishing and scaling clinical quality governance across clinical development, drug safety, regulatory affairs, and vendor management. You'll drive quality strategy for our portfolio including varegacestat (gamma secretase inhibitor with NDA submitted to the FDA), IM-1021 (ROR1-targeted antibody-drug conjugate), IM-3050 (FAP-targeted radiotherapy), IM-1617 (solid tumor ADC), and early-stage programs. This position offers visibility across R&D governance forums, safety committees, regulatory submissions, product launch readiness, and global inspection management.

What You'll Do

• Lead development and implementation of risk-based clinical quality strategy aligned with GCP, GLP/GCLP, and GVP/GPV frameworks and company objectives
• Oversee global clinical trial quality from protocol design through regulatory submissions and health authority interactions, embedding quality into study design and monitoring strategy
• Establish clear governance structures, escalation pathways, quality metrics, and decision-making forums across internal teams, external vendors, and partner organizations
• Direct quality oversight of clinical operations, data management, trial sites, contract research organizations, central and specialty laboratories, and pharmacovigilance systems
• Champion audit programs, vendor qualification and oversight, CAPA management, and inspection readiness across FDA, EMA, MHRA, PMDA, Health Canada, and other regulatory authorities
• Lead pharmacovigilance and drug safety quality oversight across clinical development and post-marketing activities
• Support European and global launch readiness activities including PSMF/QPPV governance, local safety contacts, and regulatory inspection preparedness
• Build and manage a high-performing Clinical Quality Assurance team, setting strategic direction while remaining engaged in critical issue resolution
• Drive continuous improvement through quality metrics, audit findings, inspection intelligence, and regulatory benchmarking

What You Bring

• Bachelor's degree in life sciences, pharmacy, nursing, biochemistry, chemistry, biotechnology, or related field (advanced degree such as PharmD, PhD, MS, or MPH preferred)
• 12+ years progressive experience in quality assurance, compliance, clinical operations, or regulatory roles in pharmaceutical/biotech settings; 15+ years for Executive Director level
• Demonstrated expertise leading GCP, GLP/GCLP, or GVP/GPV quality oversight in regulated clinical environments
• Proven track record establishing and scaling quality systems, audit programs, vendor management programs, and inspection readiness programs in outsourced or hybrid operating models
• Direct experience managing global regulatory inspections and supporting product development milestones (INDs, CTAs, NDAs, BLAs, MAAs)
• Deep knowledge of clinical trial operations, data integrity, electronic systems (eTMF, EDC, CTMS, safety databases), computerized system validation (Part 11/Annex 11)
• Oncology, antibody-drug conjugate, and complex biologics experience preferred
• European product launch, EU pharmacovigilance system readiness, QPPV/PSMF governance, and EU inspection experience valued
• Excellent communication, strategic leadership, and stakeholder influence; strong project management and problem-solving in fast-paced biotech environments

Why Join Immunome, Inc.

Join a focused leadership team with deep expertise in developing first-in-class and best-in-class targeted cancer therapies, particularly in antibody-drug conjugate design and development. We're committed to building a quality-first culture that enables compliant, efficient clinical development and positions us for successful launches globally. You'll have direct impact on patient safety, data integrity, and regulatory trust while shaping quality practices from early clinical stages through commercialization and post-market commitments. Immunome is an equal opportunity employer celebrating diversity and committed to creating an inclusive environment for all employees.

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