Job Description
Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first- 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.) In addition to a portfolio of discovery-stage ADCs, our pipeline includes AL102, a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors, as well as IM-1021, a ROR1 ADC, and IM-3050, a FAP-targeted radioligand, both of which are the subject of INDs expected to be submitted in the first quarter of 2025.
Position Overview The Vice President of Pharmacovigilance & Drug Safety will be responsible for overseeing all aspects of drug safety and pharmacovigilance for our pipeline of products. This leadership role reporting to the CMO requires a strategic thinker with extensive knowledge of regulatory requirements, risk management, and safety data analysis who is also willing and able to participate in daily operations of the clinical teams. The successful candidate will build a robust safety and pharmacovigilance department dedicated to ensuring safety of participants in our clinical trials while maintaining the highest standards for worldwide regulatory compliance.
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 - Advanced degree in life sciences, pharmacology, or a related field (MD or DO preferred)
- Minimum of 15 years of experience in pharmacovigilance or drug safety, with at least 5 years in a leadership role
Knowledge and Skills - Strong knowledge of global pharmacovigilance regulations and industry standards
- Proven track record of managing safety data and conducting signal detection and risk assessment
- Demonstrated ability to build a highly functioning team
- Excellent communication, leadership, and interpersonal skills
- Ability to work collaboratively in a fast-paced, dynamic environment
- Strong analytical and problem-solving skills
E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Salary Description
$364,000 - $433,000 Immunome
Job Tags
Worldwide,