Jobs at Immunome, Inc.

Lead nonclinical safety strategy for oncology therapeutics from candidate selection through regulatory approval. Design and oversee GLP/non-GLP toxicology programs, author nonclinical regulatory sections, manage CROs, integrate toxicology with DMPK/biomarkers/pathology, advise cross-functional teams, mentor staff, and drive adoption of innovative approaches (AI, predictive toxicology, novel biomarkers) to support INDs, CTAs, NDAs, and BLAs.

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.

Provide high-level administrative support to site and/or corporate executives: manage complex calendars, coordinate meetings and travel, prepare documents and presentations, handle confidential communications, organize events, track action items, support onboarding/offboarding, and collaborate with other executive assistants to ensure smooth executive operations.

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.

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

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.

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 NetSuite ERP and related business systems enhancements across Finance, Supply Chain, HR, and G&A. Partner with stakeholders to gather requirements, configure systems, manage vendors, drive projects, ensure controls and SOX readiness, improve processes, support integrations, testing, documentation, training, and operational readiness for scalable growth.

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.

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 quality operations for clinical and commercial programs, overseeing GMP/GDP manufacturing, specifications, batch disposition, CAPA/change control, vendor/CMO oversight, inspection readiness, regulatory support, documentation control, and continuous improvement to ensure product quality throughout development and commercialization.

Lead strategy and execution for HCP engagement and congress presence to support the U.S. launch of varegacestat. Develop and manage peer-to-peer programs, speaker bureaus, advisory boards, third-party engagements, congress booth strategy, and field-facing materials. Synthesize HCP insights to inform brand strategy and ensure cross-functional execution.

Lead design, execution, and interpretation of multiple oncology clinical trials. Develop protocols, CRFs, and study documents; oversee data review and regulatory submissions; collaborate with investigators and cross-functional teams; present results to stakeholders; mentor junior staff and support site-facing activities and study committees.

Physician-level clinical development lead supporting oncology trials: medical monitoring, safety and pharmacovigilance oversight, protocol and regulatory document authorship, investigator engagement, cross-functional collaboration, biomarker integration, data review and publications, and participation in external advisory and safety meetings to advance oncology investigational programs.

Lead development and execution of global regulatory strategies for oncology therapeutics; oversee regulatory submissions (INDs, BLAs, NDAs); act as primary contact with FDA, EMA and other authorities; manage and mentor a global regulatory team; mitigate regulatory risks and ensure compliance across product lifecycle.

Lead the development of total rewards strategy, oversee compensation plans, benefits administration, and recognition programs to enhance employee engagement.

Lead and continuously improve Immunome's GxP supplier quality and audit program. Manage supplier qualification, risk classification, audits, quality agreements, CAPA follow-up, inspection readiness, and governance for CDMOs, CROs, labs, and other outsourced GxP providers. Partner cross-functionally to monitor supplier performance, escalate risks, and maintain supplier quality records and procedures.

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.