Description
Company Overview
Immunome is a clinical-stage targeted oncology company committed to developing first- 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.) In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025.
Position Summary
The Senior Director/Director of Clinical Quality Assurance (CQA) is responsible for overseeing and conducting audits for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP), and ensuring compliance with all applicable regulations and guidelines (FDA, EMA, ICH, etc.). This role ensures that all audits are planned, executed, and managed in accordance with the company’s Quality Management System (QMS) to uphold regulatory compliance. The Senior Director/Director will collaborate cross-functionally with internal teams, CROs, clinical investigators, and external partners to ensure operational excellence in clinical trials.
Primary Responsibilities
Leadership & Quality Strategy
- Develop and implement a comprehensive Clinical Quality Assurance strategy covering GCP, GLP, and GVP.
- Lead the CQA function, ensuring quality oversight of clinical trials, vendors, and regulatory activities.
- Serve as the senior CQA representative for regulatory inspections and act as a key advisor for quality and compliance matters.
- Promote a culture of quality and compliance throughout the clinical operations and research organization.
Audit Planning & Execution
- Develop and manage audit plans for clinical programs, ensuring GCP, GLP, and GVP audits are conducted according to timelines.
- Collaborate with Clinical Operations, Regulatory Affairs, and other key stakeholders to provide clinical program auditing oversight and establish audit scope across protocols.
- Lead, schedule, and conduct internal and external audits of clinical sites, CROs, laboratories, and vendors to ensure compliance with company SOPs, regulatory guidelines, and applicable standards.
- Manage vendor and site qualification processes, ensuring proper oversight through vendor assessments, contract reviews, and vendor audit reports.
- Provide regular updates to senior management on audit progress and findings, ensuring CAPAs are implemented effectively and timely.
Regulatory Inspection Management
- Lead preparation for and participate in regulatory inspections (FDA, EMA, etc.) related to clinical trials and pharmacovigilance activities.
- Ensure timely responses to regulatory authorities and audit observations, facilitating CAPAs as required.
- Act as the point of contact for hosting inspections, ensuring the company’s readiness and compliance across clinical trial activities.
Procedural Documentation & Compliance
- Develop, review, and maintain clinical quality procedural documents, including SOPs and work instructions, to ensure compliance with GCP, GLP, and GVP regulations.
- Provide training, guidance, and mentorship to staff and internal teams on GCP, GLP, GVP compliance, audit processes, and regulatory inspection readiness.
- Oversee the management and maintenance of the company’s clinical trial master files (TMF) and audit reporting through the Quality Management System (QMS).
- Track audit findings, manage audit responses, and generate audit reports, providing key insights into compliance trends and areas for improvement.
Vendor & CRO Management
- Oversee the qualification and management of CROs, clinical investigators, and other external vendors, ensuring their compliance with GCP, GLP, GVP, and contractual obligations.
- Provide feedback and performance evaluations for external contractors, ensuring audit activities meet corporate standards.
- Act as the primary liaison for contractors during audit processes, ensuring adherence to audit plans, corporate expectations, and regulatory requirements.
Continuous Improvement
- Identify and implement continuous improvement initiatives across clinical QA processes to enhance operational efficiency and maintain high compliance standards.
- Assist in the development and review of departmental SOPs, working practices, and metrics to ensure consistent quality and adherence to best practices.
- Participate in cross-functional quality improvement projects, supporting clinical operations in improving trial processes and outcomes.
Qualifications
Education & Experience
- Bachelors / Master’s degree in Chemistry, Biochemistry, Clinical Pharmacology, or related field; PhD preferred. Equivalent relevant experience will be considered.
- A minimum of 15 years of experience in pharmaceutical clinical quality assurance, with a strong background in GCP/GLP/GVP compliance and auditing.
- A minimum of 5 years of experience in a leadership role, managing a QA team and conducting clinical audits, with a focus on GLP, GCP, and/or Pharmacovigilance (PV).
Knowledge And Skills
- Experience with the development and commercialization of products, ideally with expertise in Pharmacovigilance and clinical vendor management.
- Proven experience hosting GCP regulatory inspections, managing clinical trial sites, and conducting audits of clinical operations and vendors.
- Experience with biologics and/or small molecules, biologics preferred.
- Deep 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 influencing senior leaders, with a demonstrated ability to lead organizational change and promote a quality-focused culture.
- Proficient in using electronic QMS, audit reporting tools, and quality documentation systems such as TrackWise, MasterControl, etc.
Travel
- Ability to travel up to 25%, 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.
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