Company Overview
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.
Position Overview
The Associate Medical Director, Pharmacovigilance (PV) will provide medical leadership and oversight of safety management activities across Immunome’s early phase oncology portfolio. This position will provide safety oversight for the detection, evaluation, interpretation, and communication of safety information across assigned oncology assets. Within the Pharmacovigilance function, they will be responsible for driving proactive safety surveillance, risk management, and signal detection throughout the product lifecycle - from early clinical development through post-marketing.
The ideal candidate will be a medically trained professional with an understanding of global pharmacovigilance regulations, and experience in a biotech or pharmaceutical setting. The individual should be comfortable working in a fast-paced, science-driven organization with investigational therapies, evolving safety profiles, and complex patient populations across internal departmental functions.
Responsibilities
Leadership in Drug Safety
- Provide medical oversight and leadership for all safety activities related to assigned products, ensuring patient safety across development and post-marketing phases.
- Provide medical review, interpretation, and assessment of adverse events, serious adverse events, suspected adverse reactions, adverse events of special interest, deaths, discontinuations due to adverse events, and other clinically relevant safety data.
- Support safety management teams to develop, implement, and refine pharmacovigilance strategies in alignment with corporate and regulatory objectives.
- Proactively identify, assess, and manage emerging safety signals, leading benefit-risk evaluations and risk mitigation strategies.
- Serve as the key medical point of contact for all safety-related decisions for assigned products, ensuring consistent, evidence-based assessments.
Safety Data Evaluation and Signal Management
- Support ongoing safety data review and signal detection using multiple data sources (clinical trial data, spontaneous reports, literature, and external databases).
- Identify, evaluate, and escalate emerging safety concerns, including potential signals, clusters of events, increased frequency or severity of known risks, and events requiring risk mitigation.
- Author or contribute to signal evaluation reports, safety assessment memos, safety topic reviews, and benefit-risk summaries.
- Track assigned signals and safety topics through completion, ensuring timely documentation, governance review, and regulatory alignment.
- Provide medical input into signal evaluation, risk-benefit analyses, and labeling recommendations.
- Support preparation of aggregate safety reports, including Development Safety Update Reports (DSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), IND annual reports, and risk management plans (RMPs).
Regulatory Strategy and Documentation
- Draft safety-related sections of regulatory submissions including INDs, NDAs, BLAs, and MAAs.
- Partner with RA during interactions with regulatory authorities (FDA, EMA, MHRA, etc.) on product safety matters.
- Collaborate with Regulatory Affairs to ensure appropriate inclusion of safety information in the Investigator’s Brochure (IB), Informed Consent Forms (ICF), and other study documents.
- Ensure compliance with all applicable pharmacovigilance requirements, ICH guidelines, and Good Pharmacovigilance Practice (GVP) standards.
Cross-Functional Collaboration and Communication
- Partner with Clinical Development, Biostatistics, and Medical Affairs to support signal detection, safety data analysis, and communication of emerging findings.
- Participate in clinical study design by contributing to safety endpoint development and monitoring plans.
- Collaborate with Translational Sciences and CMC functions to understand mechanistic insights related to safety signals.
- Communicate key safety updates and risk assessments to internal stakeholders.
External Representation and Leadership
- Participate in internal and external safety meetings, advisory boards, and scientific conferences.
- Engage with external safety experts, key opinion leaders (KOLs), and partners to advance understanding of drug safety and risk mitigation strategies.
- Assist in oversight of external PV vendors and ensure quality, compliance, and alignment with Immunome’s standards.
- Support business development activities by providing safety evaluations of potential in-licensing or collaboration opportunities.
Team Development and Oversight
- Foster a culture of scientific excellence, collaboration, and regulatory compliance within the PV organization.
- Contribute to long-term planning for the PV function, including system development, staffing, and process optimization.
- Contribute to inspection readiness and ensure assigned activities are completed in accordance with company procedures, regulatory requirements, and applicable pharmacovigilance standards.
Qualifications
- M.D., D.O., or equivalent medical degree; board certification in Medical Oncology, Hematology, or Immunology preferred.
- Minimum of 3 - 5 years of combined clinical and pharmacovigilance experience, including 2+ years in a leadership capacity within the pharmaceutical or biotechnology industry or equivalent.
- Proven track record in global pharmacovigilance, including experience managing pre- and post-marketing products.
- Experience drafting safety-related regulatory submissions (DSURs, PBRERs, RMPs) and participating in health authority interactions.
- Oncology or immunology experience strongly preferred.
Knowledge and Skills
- Working knowledge of global pharmacovigilance regulations (FDA, EMA, ICH, MHRA) and GVP standards.
- Experience in safety data evaluation, signal detection, and benefit-risk assessment methodologies.
- Experience developing and managing safety management teams and vendor partnerships.
- Strong analytical and strategic thinking skills with the ability to synthesize complex safety data.
- Strong written and verbal communication skills; ability to effectively interact with internal teams, regulators, and external stakeholders.
- Ability to manage multiple priorities and projects in a dynamic, fast-paced biotech environment.
- Demonstrated ability to influence cross-functional teams and executive leadership.
