Jobs at Immunome, Inc.

Lead ADC conjugation process development from milligram to multi-gram (>100 g) scale, optimizing conjugation and purification (TFF/UF-DF, chromatography), executing DOE/OFAT studies, coordinating tech transfers and CDMO partnerships, preparing GMP documentation and regulatory module 3 materials, and supporting IND/BLA activities and GLP tox studies while advising cross-functional teams.

Support operational execution of oncology clinical studies by coordinating study start-up, site activation, trial conduct, vendor/CRO interactions, eTMF/CTMS documentation, site communications, and inspection-readiness activities while ensuring GCP and SOP compliance.

The Global Regulatory Lead will develop and execute regulatory strategies for therapeutic projects, ensuring compliance and success in submissions while leading cross-functional teams and managing risks.

Immunome is seeking proactive candidates to join their talent community for future job opportunities in oncology therapeutics. Interested applicants are encouraged to submit their resumes for consideration when relevant roles become available.

The role oversees CDMO operations, ensuring supply requirements, managing relationships, supporting contract negotiations, and monitoring performance to meet Immunome's biopharmaceutical needs.

The Pharmacovigilance Operations Manager oversees global safety operations, vendor management, compliance, and cross-functional collaboration in clinical-stage oncology programs.

Lead full-cycle recruiting for clinical, development, and commercial roles in oncology biotech. Source, screen, interview, coordinate offers, maintain Greenhouse ATS records, provide market insights, and support contract/contingent hiring while partnering with hiring managers and HR.

Lead QC strategy and execution for biologics and ADC programs, overseeing GMP release and stability testing, method transfer/validation, investigations, external lab/CDMO management, and QC documentation. Provide scientific and regulatory support for CMC submissions, mentor staff, and align QC deliverables with cross-functional development timelines.

Manage and improve contract intake, triage, CLM workflows, and contract data. Coordinate with Legal, Finance, Procurement, IT, and business teams to ensure complete, budget-aligned contracts. Serve as CLM power user, maintain dashboards and repository hygiene, provide hands-on contract operations and Legal Operations backup, and drive process improvements.

Provide strategic and operational leadership for site-facing clinical trial execution across Immunome's oncology portfolio. Lead and grow the Clinical Site and Trial Operations team, manage CROs/vendors, ensure regulatory compliance (ICH-GCP, FDA, EMA), support budget/resource planning, and collaborate cross-functionally to deliver trials on time and with data integrity. May lead outsourced or mixed-model trials and support regulatory submissions and inspection readiness.

The Principal Scientist will optimize purification processes for mAbs, coordinate with CDMO partners, and oversee compliance and documentation for regulatory submissions.

Lead the development and execution of integrated non-personal promotion strategies and digital marketing campaigns to drive oncology product launch and HCP engagement.

The Executive Director, Investor Relations will manage investor relations and corporate communications, ensuring effective communication with investors and analysts, drafting core materials, and coordinating multiple stakeholders.

Lead the discovery and development of novel antibody-drug conjugates (ADCs) for cancer therapies by leveraging deep knowledge in oncology and pharmacology.

Oversee regulatory affairs for early and late-phase oncology drug development, ensuring compliance and strategic guidance in regulatory submissions and interactions.

Contract manager to oversee outsourced GMP stability programs for biologics (mAb, DS, DP, ADC). Maintain stability plans, pull calendars, and vendor oversight; review and trend stability data, assess OOS/OOT, prepare shelf-life/retest recommendations, and manage timelines, risks, and cross-functional stakeholders to ensure regulatory-compliant deliverables.

Lead pharmacometrics strategy and execution across oncology programs, including population PK/PKPD, exposure-response, PBPK/QSP modeling, simulation, regulatory submission support, vendor management, and mentoring a team to inform dose selection and development decisions.

Lead U.S. regulatory strategy for advertising, promotional labeling, and medical communications across oncology portfolio. Serve as A&P subject matter expert, lead MLR review and OPDP interactions, oversee promotional submissions and compliance, develop A&P policies/SOPs and training, manage agencies and build a high-performing team to enable compliant product launch and post-market promotion.

Lead implementation and maintenance of the regulated Document Control program within the eQMS. Own document lifecycle management, author and maintain SOPs/templates, ensure compliance with 21 CFR Part 11/EU Annex 11/ICH Q10 and cGMP, support document owners, design training materials, and mentor users across the organization.

Provide statistical leadership for clinical trial design, analysis, and regulatory submissions. Develop SAPs, oversee outsourced vendors, conduct trial and exploratory analyses, support regulatory interactions, and drive process improvements, reporting, and data visualization in oncology drug development.