Jobs and Careers

Senior / Executive Director, Clinical Quality Assurance

United Statesfull_timeVerifiedPosted 10 Jul 2026

💰 $353,601/yr($260,000/yr – $353,601/yr)

About the role

Company Overview

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.

Position Overview

Immunome is seeking a highly experienced and strategic Senior / Executive Director, Clinical Quality Assurance to lead and implement global clinical quality strategies supporting Immunome’s oncology portfolio. This role will provide quality leadership across clinical development, clinical operations, pharmacovigilance/drug safety, nonclinical and translational partners, data management, regulatory affairs, and external vendors.

The successful candidate will bring deep expertise in GCP, GLP/GCLP, and GVP/GPV expectations, global inspection readiness, outsourced development oversight, and fit-for-purpose quality systems. This position offers a highly visible leadership opportunity to scale Immunome’s clinical quality capabilities, ensure patient safety and data integrity, and support high-quality execution from clinical development through regulatory submission, launch readiness, and post-marketing commitments.

Responsibilities

Clinical Quality Strategy and Governance

Develop and implement a risk-based Clinical QA strategy across GCP, GLP/GCLP, and GVP/GPV activities aligned with Immunome’s pipeline, corporate objectives, and global development plans.

Serve as a senior quality leader and subject matter expert for clinical quality matters, including quality risk management, inspection readiness, regulatory intelligence, issue escalation, and quality governance.

Establish clear roles, responsibilities, escalation pathways, quality metrics, and decision-making forums across internal teams, vendors, partners, affiliates, and consultants.

Represent Clinical QA on R&D governance forums, program teams, safety governance forums, quality councils, launch readiness teams, and regulatory inspection teams.

Clinical Trial and Development Oversight

Provide strategic and hands-on QA oversight for global clinical trials from protocol development and study start-up through conduct, closeout, clinical study reports, regulatory submissions, and inspections.

Partner with Clinical Operations, Clinical Development, Medical Affairs, Biostatistics, Data Management, Regulatory Affairs, and CROs to embed quality into study design, monitoring strategy, data flow, protocol deviation management, and trial documentation.

Ensure clinical trials are conducted, documented, and reported in compliance with applicable regulations, ICH GCP, study protocols, informed consent requirements, Immunome SOPs, and quality agreements.

Oversee clinical quality activities, including site audits, CRO oversight, eTMF quality, protocol deviations, serious breach assessments, nonconformances, root cause analysis, CAPA development, and CAPA effectiveness.

PV/GVP and Launch Readiness

Provide QA oversight of pharmacovigilance and drug safety systems across clinical development and post-marketing activities, including safety case intake, processing, medical review, expedited reporting, aggregate reporting, signal management, safety database governance, and vendor oversight.