Oncology PV Medical Director - Safety Leadership

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

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.