Jobs at Immunome, Inc.

Leads enterprise learning, development, engagement, and performance management programs for a rapidly scaling biotech organization. Responsibilities include developing leadership and manager enablement programs, improving performance processes, building competency frameworks, supporting succession planning and internal mobility, managing learning systems and vendors, overseeing budgets, and establishing metrics and dashboards to continuously improve talent development initiatives.

Provides scientific leadership for oncology clinical development programs, including study design, clinical strategy, data interpretation, regulatory documentation, vendor oversight, and cross-functional execution. The role authors and reviews protocols, investigator brochures, informed consent forms, clinical study reports, and regulatory submissions; supports medical monitoring and health authority interactions; manages external partners; and mentors clinical scientists while ensuring GCP compliance, patient safety, and data quality.

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.

The Associate Scientist will produce and characterize recombinant proteins, execute analytical assays, collaborate across teams, manage protein inventory, and document findings.

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 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 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.

Serve as the primary R&D finance business partner for clinical studies: own accruals, forecasting, month-end close, variance analysis, vendor reconciliation, and study-level financial reporting. Build forecasts and models, support budgeting/long-range planning, enable cross-functional partnership with Clinical Operations and Development, and drive process improvements and automation for R&D finance.

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.

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.

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 clinical systems strategy and delivery for Development, driving implementation and integration of eTMF, CTMS, analytics, and AI-enabled dashboards. Oversee vendor management, inspection-ready GxP compliance, budgets, KPIs, and a CDS team to improve trial visibility, data integrity, and operational performance.

Lead commercial analytics, reporting, and enablement to prepare for product launch and scale field operations. Define analytics strategy, targeting/segmentation, call planning, incentive compensation design and governance, dashboards/KPIs, SOPs, and training. Partner cross-functionally to ensure compliant, actionable insights, administer IC processes, manage vendors, and support performance management and launch readiness.

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

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.

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.

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.