Job Description

Vice President, Pharmacovigilance & Drug Safety

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors.

Position Overview

The Vice President, Pharmacovigilance & Drug Safety will serve as the global safety leader for Immunome's pipeline, reporting directly to the Chief Medical Officer. This executive will provide strategic vision and operational oversight across all aspects of drug safety, signal detection, and risk management, while ensuring regulatory compliance worldwide. The VP will build and lead a best-in-class pharmacovigilance function that partners cross-functionally to enable the advancement of innovative oncology programs from early development through commercialization.

Responsibilities

• Develop and implement the pharmacovigilance strategy in alignment with regulatory requirements and company goals
• Build and develop a team of drug safety professionals to evaluate and oversee safety reporting and management
• Oversee the collection, analysis, and reporting of safety data from ongoing clinical trials
• Oversee the development of drug safety databases and reporting procedures to ensure regulatory compliance
• Lead the preparation and submission of safety reports, including Periodic Safety Update Reports and other regulatory filings
• Lead the safety analysis for regulatory submissions including NDAs, BLAs, and MAAs
• Ensure compliance with global regulatory requirements and guidelines, including those from the FDA, EMA, and ICH
• Collaborate with Clinical Development, Regulatory Affairs, and Quality Assurance teams to ensure integrated approaches to drug safety. Provide expert safety guidance during development of protocols and other site-facing documents
• Provide expert guidance on risk management and mitigation strategies throughout the product lifecycle
• Conduct regular training for staff on pharmacovigilance practices and regulatory updates
• Analyze safety data trends and provide actionable insights to senior management and stakeholders
• Represent the pharmacovigilance function in meetings with regulatory authorities and during audits
• Provide medical expertise to clinical teams in evaluation of safety events

Qualifications

• M.D., D.O., or equivalent advanced degree in life sciences or pharmacology required; additional training in oncology or drug safety highly preferred.
• A minimum of 10 years of pharmacovigilance and drug safety experience in biotech and/or pharmaceutical settings, including a minimum of 5 years in a senior leadership role with global responsibilities.

Knowledge and Skills

• Strong knowledge of global pharmacovigilance regulations and industry standards. Deep expertise in global pharmacovigilance regulations (FDA, EMA, ICH, MHRA, PMDA) and evolving industry best practices.
• Proven track record of managing safety data and conducting signal detection and risk assessment. Proven ability to lead signal detection, aggregate safety data review, benefitrisk assessment, and implementation of proactive risk management strategies.
• Demonstrated ability to build a highly functioning team. Demonstrated success in building, mentoring, and scaling high-performing global pharmacovigilance and drug safety teams.
• Excellent communication, leadership, and interpersonal skills.
• Ability to work collaboratively in a fast-paced, dynamic environment.
• Strong analytical and problem-solving skills.

Washington State Pay Range

$364,000 - $433,000 USD

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

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