Director, Clinical Quality Assurance

Company Overview

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors.

Position Overview 

The Director of Clinical Quality Assurance is responsible for supporting the strategy for Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and Good Laboratory Practices (GLP) quality oversight at Immunome. 

The individual will partner with QA leadership and stakeholders to ensure phase-appropriate QA support and audits are executed for Immunome pre-clinical, clinical and pharmacovigilance programs in compliance with applicable regulations, ICH guidelines, and industry best practices. 

Responsibilities 

• Provide overall Clinical QA support for internal clinical and pharmacovigilance teams.  

• Lead and conduct GCP, GLP and GVP audits of Internal Processes, Investigator Sites and external vendors (e.g., CROs, Laboratories, etc.).  

• Manage vendor qualification processes, ensuring proper oversight through vendor assessments, contract reviews, and vendor audit reports. 

• Provide regular updates to QA leadership on audit progress and findings, ensuring CAPAs are implemented effectively and timely. 

• Track audit findings, manage audit responses, and generate audit reports, providing key insights into compliance trends and areas for improvement. 

• Support and participate in regulatory inspections readiness activities as well as inspections (FDA, EMA, etc.) related to clinical trials and pharmacovigilance activities. 

• Ensure timely responses to regulatory authorities and audit observations, facilitating CAPAs as required. 

• Develop, review, and maintain department SOPs as well as clinical quality procedural documents to ensure compliance with GCP, GLP, and GVP regulations. 

• Oversee the qualification and management of CROs, investigator sites and other external vendors, ensuring their compliance with GCP, GLP, GVP, and contractual obligations. 

• Identify and support the implementation of continuous improvement initiatives across clinical QA processes to enhance operational efficiency and maintain high compliance standards. 

• Participate in cross-functional quality improvement projects, supporting clinical operations in improving trial processes and outcomes. 

• Partner cross functionally to enable transparency and escalation of development quality risks and issues, collaborating to address challenges and constraints.  

• Serve as a resource to pre-clinical, clinical and pharmacovigilance teams on compliance issues and regulatory risks. 

Qualifications 

• Bachelor’s degree in Biology, Chemistry, Biochemistry, Clinical Pharmacology, or related field; Master’s degree preferred. Equivalent relevant experience will be considered. 

• A minimum of 12 years of experience in the pharmaceutical industry, with a strong background in GCP/GLP/GVP compliance and/or auditing is preferred; Prior experience in both big and small Pharma is preferred. 

• A minimum of 5 years of direct GCP lead auditor experience is required. 

Knowledge and Skills 

• Experienced with the development and commercialization of products, ideally with expertise in Pharmacovigilance and clinical vendor management. 

• Proven experience supporting GCP/PV regulatory inspections, managing clinical trial sites, and conducting audits of clinical operations and vendors. 

• Expert knowledge of GLP, GCP, GVP, FDA, EMA, ICH regulations, and international standards for clinical research and pharmacovigilance. 

• Strong communication skills, both verbal and written, with the ability to work independently and collaboratively in a cross-functional, global team. 

• Excellent analytical, organizational, and problem-solving skills with a strong ability to assess regulatory risk and propose practical solutions. 

• Skilled in project management, negotiation, and ability to support organizational change and promote a quality-focused culture. 

• Proficient in using electronic QMS, audit reporting tools, and quality documentation systems such as TrackWise, SalesForce, Veeva, MasterControl, DOT Compliance, etc. 

• Ability to travel up to 35%, including both domestic and international. 

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.