Jobs at Immunome, Inc.

Develop and implement bioanalytical assays supporting clinical-stage oncology programs. Oversee CRO laboratory work, ensure scientific and regulatory compliance, manage external vendors, contribute bioanalytical expertise to cross-functional teams, and author clinical protocols, analysis plans, reports, and regulatory submissions. The role requires hands-on method development, validation, troubleshooting, and experience supporting regulated pharmaceutical or biotechnology programs across multiple modalities.

Leads statistical programming for clinical studies across the full lifecycle, including SAS programming, CDISC-compliant SDTM and ADaM datasets, tables, listings, figures, Define.xml, and submission packages. Oversees CRO deliverables, validates datasets and outputs, manages timelines and risks, collaborates cross-functionally, maintains programming standards and tools, ensures regulatory compliance, and mentors junior programmers. Supports clinical trial analyses, regulatory submissions, data quality, and departmental process improvements.

Develops, validates, documents, and delivers SAS programming outputs for clinical trials, including CDISC-compliant SDTM and ADaM datasets, tables, listings, figures, Define.xml, and reviewer guides. Validates CRO deliverables, supports regulatory submissions, maintains programming standards and reusable tools, and collaborates with biostatistics, data management, clinical operations, and safety teams. Provides technical leadership on complex programming activities and contributes to process improvements and submission readiness.

Leads Development Quality Assurance strategy for global clinical development programs. Responsibilities include risk-based audits, regulatory inspection readiness, SOP and QMS development, CAPA and quality event oversight, CRO and vendor quality management, training, quality metrics, and continuous improvement. The role partners cross-functionally across clinical, regulatory, pharmacovigilance, biometrics, and manufacturing teams while applying AI, machine learning, and analytics to improve quality oversight and compliance.

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.

Supports clinical trial execution across sites, vendors, and study teams. Responsibilities include maintaining timelines and trial documentation, managing Trial Master File completeness, assisting with site activation and monitoring, reviewing data and protocol deviations, tracking vendors, contracts, invoices, budgets, and action items, and supporting data cleaning. The role also contributes to process improvements and guides junior team members while ensuring compliance with protocols, ICH-GCP, regulations, and SOPs.

Oversee external CDMO and supplier operations supporting clinical and commercial manufacturing programs. Coordinate cross-functional teams, monitor manufacturing progress and supplier KPIs, manage risks, review documentation, support contracts and budgets, and facilitate technology transfers and supplier qualification. The role requires small-molecule manufacturing expertise, cGMP knowledge, strong collaboration skills, and up to 25% domestic and international travel.

Leads Immunome’s external manufacturing operations, including CDMO oversight, supplier governance, team development, manufacturing network strategy, supply risk management, and cross-functional alignment. Provides executive updates on manufacturing performance, capacity, financial considerations, and supply risks; supports regulatory submissions and inspections; and drives continuous improvement across Technical Operations processes. Requires extensive biotechnology or pharmaceutical manufacturing experience, strong cGMP and quality systems knowledge, and domestic and international travel up to approximately 25%.

Build relationships with experienced oncology sales professionals for anticipated commercial field sales openings. The role will support future launches of oncology therapeutics, particularly treatments for rare cancer subtypes and oral oncology agents. Candidates should have a strong sales performance record and relevant oncology product-launch experience. Specific territories and the number of positions are not yet determined.

Coordinates onsite and virtual interviews across multiple roles, serves as a primary candidate contact, organizes kickoff, debrief, and offer meetings, maintains accurate ATS records, and supports candidate travel, expenses, and onboarding logistics. Partners with recruiters and hiring teams to deliver an organized candidate experience in a fast-paced biotech environment.

Leads small-molecule analytical development and QC activities across method development, validation, transfer, troubleshooting, stability, characterization, and lifecycle management. Oversees CDMO, CRO, and contract laboratory relationships; leads investigations and root-cause analyses; develops control strategies and regulatory documentation; authors CMC and submission content; and supports analytical capability building for oncology pipeline programs.

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 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.

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 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 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.

Manage outsourced cGMP clinical packaging, labeling, and distribution via CDMOs. Serve as primary CDMO liaison, lead virtual management teams, support batch review, logistics, sourcing, audits, tech transfers, and risk mitigation to ensure clinical drug supply availability.

Lead global regulatory CMC strategy and submissions (IND, CTA, IMPD, NDA, amendments) across clinical and commercial stages. Serve as CMC regulatory lead on cross-functional teams, author and review submission CMC content, manage health authority interactions and briefing responses, support inspections, and ensure compliance with ICH, FDA, and EMA requirements.

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.