Associate Director, EDC Programming

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.) 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 ADC with an active IND, and IM-3050, a FAP-targeted radioligand, which is the subject of an IND expected to be submitted in the first quarter of 2025. 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 Associate Director, EDC Programming will lead the development, implementation, and maintenance of electronic data capture (EDC) systems to support Immunome’s clinical trials. This role is a strategic and hands-on leader in EDC programming, responsible for ensuring high-quality, compliant clinical databases and seamless data capture processes across global studies.

Responsibilities

• Lead vendor evaluation and implementation of an EDC system (e.g., Medidata Rave, Veeva CDMS, or similar).
• Serve as subject matter expert for EDC across all phases of clinical development.
• Lead the design, development, testing, and deployment of study databases, CRFs, edit checks, custom functions, and integrations.
• Collaborate cross-functionally with Clinical Operations, Biostatistics, Medical Monitoring, and Clinical Data Management to ensure database builds align with protocol and data strategy.
• Oversee and perform User Acceptance Testing (UAT), issue tracking, and resolution.
• Oversee development and maintenance of a global library, ensuring consistency and quality across multiple studies and programs.
• Ensure EDC systems are validated and compliant with GCP, 21 CFR Part 11, and other relevant regulations.
• Manage timelines and deliverables for multiple studies and vendors.
• Review and contribute to SOPs, work instructions, and training documents related to EDC systems.
• Mentor junior programmers and provide technical guidance across the organization.
• Evaluate and implement new tools or features to optimize clinical data flow and integration.
• Collaborate with external vendors/CROs and ensure adherence to Immunome’s quality standards.

Qualifications

• A minimum of a Bachelor’s degree in relevant field.
• A minimum of 8 years of Clinical Data Management and/or EDC programming experience in the biotechnology or pharmaceutical industries.
• A minimum of 1 year of leadership experience is strongly preferred.

Knowledge and Skills

• Proven proficiency in building complex CRFs, edit checks, and custom functions in an EDC system.
• Understanding of CDASH/CDISC standards, data flow, and integration with downstream systems.
• Experience in managing vendor relationships.
• Strong knowledge of FDA, ICH-GCP, and 21 CFR Part 11 compliance.
• Excellent communication, project management, and leadership skills.
• Ability to thrive in a fast-paced, cross-functional, and evolving environment.

E/E/O

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