Director of Pharmacovigilance – Oncology; Remote

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Clinical, Oncology Full Time

30+ days ago Requisition

Salary Range: $ To $ Annually

ABOUT IMMUNEERING

Immuneering Corporation (Nasdaq: IMRX) is a clinical-stage biopharmaceutical company developing oncology therapies using its proprietary Deep Cyclic Inhibition platform. Our lead asset, atebimetinib (IMM-1-104), is an oral, once-daily Deep Cyclic Inhibitor of MEK in active Phase 2 and Phase 3 (MAPKeeper 301) clinical trials in pancreatic cancer and RAS-mutant non-small cell lung cancer, as well as additional solid tumor programs. We are committed to delivering transformative treatments to patients with limited options through rigorous science and a collaborative, mission-driven culture.

POSITION SUMMARY

Immuneering is seeking an experienced Director, Pharmacovigilance to build and lead our pharmacovigilance (PV) function during a pivotal period of clinical growth. Reporting to senior leadership, this individual will be responsible for the end-to-end safety surveillance strategy across our oncology portfolio, including our global Phase 3 program. The Director will establish PV systems, policies, and processes; oversee safety data collection and reporting;

and serve as the internal PV expert across clinical, regulatory, and medical affairs functions. This is a high-impact, hands-on leadership role ideal for a seasoned PV professional eager to shape a function from the ground up at a dynamic, science-led company.

KEY RESPONSIBILITIES

Safety Data Management & Reporting

• Oversee receipt, processing, medical review, and regulatory submission of Individual Case Safety Reports (ICSRs), including serious adverse events (SAEs) and SUSARs.
• Ensure timely preparation and submission of aggregate safety reports, including DSURs, PSURs/PBRERs, and PADERs.
• Lead expedited and aggregate reporting to health authorities globally; maintain awareness of country-specific reporting requirements across trial sites.
• Oversee SAE reconciliation between the safety database and clinical trial databases.
• Establish and lead a formal signal detection and management process, including regular review of internal safety data and external literature/regulatory sources.
• Conduct and document benefit-risk assessments; escalate emerging safety signals to relevant stakeholders and governance committees.
• Develop and implement risk minimization measures and risk management plans (RMPs/REMSs) as required.
• Prepare safety sections for Investigator Brochures (IBs), clinical study protocols, informed consent forms, and regulatory submissions.

Cross-Functional Collaboration

• Partner closely with Clinical Operations, Clinical Development, Regulatory Affairs, Data Management and Biostatistics to integrate safety considerations throughout the drug development lifecycle.
• Serve as the primary PV point of contact for health authority interactions on safety topics, including responses to queries and participation in safety-related meetings.
• Collaborate with Data Safety Monitoring Boards (DSMBs) and internal safety review committees, providing safety data summaries and expert input.
• Work closely with PV CRO, safety database vendors, and other third-party service providers; ensure compliance with contractual and regulatory obligations.
• Manage PV agreements, including safety data exchange agreements (SDEAs) with partners and collaborators (e.g., Regeneron).
• Conduct oversight audits and quality checks of vendor-generated safety reports and database entries.

Team & Function Building

• Foster a culture of patient safety, quality, and continuous improvement.
• Prepare and manage a PV department budget.

QUALIFICATIONS

Required

• M.D. required
• Minimum 5-8 years of pharmacovigilance experience in the biopharmaceutical industry, with at least 1 years in a leadership or director-level role.
• Demonstrated expertise in global PV regulations and guidelines (FDA 21 CFR Parts 312/314/600, EMA Good Pharmacovigilance Practice, ICH E2A/E2D/E2E/E6).
• Experience overseeing all aspects of ICSR management, aggregate report authorship, and signal detection.
• Oncology drug development experience, including familiarity with oncology-specific safety profiles.
• Track record of successful health authority interactions on PV matters.
• Experience managing or overseeing PV safety databases (e.g., Argus, ARISg, Oracle LSH).
• Strong scientific acumen with the ability to independently conduct and…