Medical Director, Pharmacovigilance Bothell, Washington, United States

Immunome, Inc.; Bothell (WA); On-site; USD 267,000 - 325,000; Full time

Job summary

A clinical-stage oncology company seeks a Medical Director in Pharmacovigilance to lead safety strategies and manage drug safety evaluations. The role encompasses cross-functional collaboration ensuring patient safety and involves tactical responsibilities in both pre- and post-marketing contexts. Applicants should have an MD and relevant experience in pharmaceutical drug safety.

Qualifications

• Minimum 3 years of drug safety and pharmacovigilance experience in pharma or biotech.
• Experience as a product safety lead for pre- and post-marketing products.
• In-depth knowledge of pharmacovigilance regulatory requirements.

Responsibilities

• Lead safety management team to develop clinical safety strategies.
• Prepare and review aggregate safety reports and risk management plans.
• Represent pharmacovigilance team at regulatory interactions and scientific forums.

Skills

Leadership

Signal Detection

Cross-functional Collaboration

Medical Oversight

Multitasking

Education

MD or equivalent

Board certification in Medical Oncology or Hematology

Tools

Regulatory Filing Documents

Job description

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 Medical Director, Pharmacovigilance, will proactively provide expert medical leadership in the ongoing safety evaluation of assigned products. This role will lead the safety management team and play a key part in shaping clinical safety strategies, driving signal detection and risk mitigation plans, and ensuring seamless cross-functional collaborations and communications to protect patient safety.

Responsibilities

• Lead the safety management team to develop, implement, and prioritize the clinical safety strategies across the product lifecycle for assigned products.
• Lead safety data review and assessment of benefit-risk profile and communication of safety information for assigned products on regular and on-going basis.
• Prepare, author, and review periodic aggregate reports (IND Annual Reports, Development Safety Update Reports (DSUR), Periodic Benefit Risk Evaluation Report (PBRER), etc.) and risk management plan (RMP).
• Collaborate with cross-function teams to ensure appropriate and consistent safety information is incorporated into study protocols, the Investigator’s Brochure (IB), Company Core Data Sheet (CCDS), informed consent form (ICF), etc.
• Contribute to preparation and review of relevant sections of the Regulatory Authority filing and submission documents for NDs, NDA/BLA/MAAs, etc.
• Provide medical guidance and oversight to pharmacovigilance physicians, scientists, and case reviewers.
• Represent the pharmacovigilance team internally/externally at meetings, regulatory interactions, and/or scientific forums, as needed.
• Provide support to other PV related activities, such as vendor oversight and PV agreement development.

Qualifications

• MD or equivalent, with experience in oncology, hematology, immunology, or related fields.
• Board certification in Medical Oncology, Hematology, or a related field is preferred.
• A minimum of 3 years of drug safety and pharmacovigilance experience in pharmaceutical or biotech industry.

Knowledge and Skills

• Experience as a product safety lead for both pre- and post-marketing products.
• Experience in authoring and reviewing safety related documents, such as DSUR, IZB, PBRERs/PADERs.
• Demonstrated ability to perform effectively in a matrixed and dynamic environment, ability to lead and collaborate within complex organization, across functions and geographies; to work in an entrepreneurial culture.
• In-depth knowledge of pharmacovigilance regulatory requirements, ICH guidance, and other relevant regulatory guidance.
• Oncology experience strongly preferred.
• Demonstrated ability to multi-task, prioritize options, anticipate challenges, identify and resolve issues, and positively influence the team in matrix environments.

Washington State Pay Range

$267,187 - $324,247 USD

E/E/O

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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