Associate Medical Director, Pharmacovigilance

Immunome, Inc.; Bothell (WA); On-site; USD 222,288 - 294,013; Full time

Job summary

Immunome, Inc. seeks an Associate Medical Director, Pharmacovigilance to provide medical leadership across an oncology safety program, spanning early development to post-marketing.

You will oversee signal detection, safety data interpretation, and risk management for multiple assets in a fast-paced biotech setting. The role requires an MD/DO or equivalent, 3–5 years PV experience with leadership exposure, and a track record in global pharmacovigilance, including safety submissions.

Qualifications

• MD, DO, 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.

Responsibilities

• Lead safety activities for assigned products across development and post-marketing phases.
• Review and interpret adverse events, SAEs, suspected ADRs, and other safety data.
• Support safety management teams to implement pharmacovigilance strategies.
• Identify and manage emerging safety signals and risk mitigation strategies.
• Serve as medical point of contact for safety decisions.
• Collaborate with safety data review, signal detection using multiple data sources.
• Contribute to safety reports and regulatory documents (DSURs, PBRERs, RMPs).
• Ensure compliance with ICH and GVP standards.
• Partner with Clinical Development, Biostatistics, and Medical Affairs for signal communication.
• Contribute to study design by safety endpoint development and monitoring plans.
• Collaborate with Translational Sciences to understand mechanistic safety insights.
• Communicate safety updates to internal stakeholders and leadership.
• Assist in external PV vendor oversight and safety evaluations for partnerships.
• Support inspection readiness and process optimization within PV.

Skills

Pharmacovigilance

Medical knowledge

Regulatory awareness

Cross-functional collaboration

Leadership

Education

MD/DO or equivalent

Job description

Associate Medical Director, Pharmacovigilance

Bothell, Washington, United States

Overview

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. Our pipeline includes varegacestat (NDA submitted to the U.S. FDA), IM-1021 (clinical-stage ROR1 ADC), IM-3050 (IND-cleared FAP-targeted radiotherapy), and IM-1617 (IND-cleared solid tumor ADC). We are advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets. We are seeking a medical leader to oversee pharmacovigilance activities across Immunome’s oncology portfolio.

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 role will oversee safety signal detection, evaluation, interpretation, and communication of safety information across assigned assets, and drive proactive safety surveillance, risk management, and signal detection throughout the product lifecycle—from early clinical development through post-marketing.

The ideal candidate is 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 DSURs, 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 Regulatory Affairs 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.

Compensation

Washington State Pay Range: $222,288 - $294,013 USD

Equal Opportunity

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.