Head of Drug Safety

Head of Drug Safety

Company Overview

Our client is a small, clinical-stage biotechnology company advancing an investigational, allogeneic cell therapy through a registrational trial in T-cell malignancies and toward Biologics License Application (BLA) submission. Patient safety is central to the company's mission, and it is building a lean, high-quality drug safety function that supports late-stage development, regulatory submission, and the transition to a marketed product.

Position Summary

The Head of Drug Safety will lead the company's drug safety function, with accountability for safety strategy, medical oversight over drug safety/pharmacovigilance, MedWatch/SUSAR narrative review and regulatory reporting, aggregate safety analysis, signal detection, benefit-risk assessment, and BLA safety and inspection readiness. Reporting to the Chief Medical Officer and sitting within the Research and Clinical Development organization, this professional will serve as the safety leader for the lead program and supporting studies.

This is a hands-on leadership role in a small biotechnology company setting. The Head of Drug Safety will personally drive safety deliverables while leading a lean team of one to two direct reports (Safety Operations and Safety Scientist), and will scale the function as the program moves through regulatory approval and launch.

Key Responsibilities

Safety Strategy & Leadership

• Define and execute the drug safety strategy for the registrational program, including safety surveillance plans, benefit-risk framework, and BLA safety deliverables.
• Serve as the company's safety physician / safety lead on the program team; provide safety input into protocol design, informed consent, risk mitigation, and clinical development decisions.
• Lead safety presentations to DSMB.
• Own the medical monitoring interface for safety events in partnership with Clinical Development and Clinical Science.
• Represent Drug Safety in interactions with the FDA and other health authorities, DMC/IDMC committees, IRBs/IECs, investigators, and partners.

Medical Input and Oversight for Regulatory Reporting (ICSRs)

• Provide medical oversight and supervision of regulatory individual case safety report (ICSR) reporting including medical review, causality assessment, analysis of similar events, and quality control.
• Oversee compliance with expedited (7/15-day) and periodic safety reporting to FDA and other health authorities per 21 CFR 312.32, ICH E2A/E2D, and applicable ex-US requirements.
• Oversight of activities related to safety database strategy.
• Oversight of safety vendors and CROs, including case-processing partners; maintain safety data exchange agreements (SDEAs) with partners and licensees.

Aggregate Safety Reports, Signal Detection & Benefit-Risk

• Provide medical leadership in aggregate safety analyses across the program; author DSURs, IND annual reports, and periodic safety updates.
• Represent Drug Safety in communications with health and regulatory authorities including in response to aggregate safety reviews and reports.
• Create and maintain a signal detection management process including regular and ad hoc cumulative safety reviews of safety signals.
• Oversee the Safety Management Plan, signal management process, risk management planning, and benefit-risk assessments; ensure timely escalation and documentation of emerging safety topics.
• Lead preparation of DSMB/IDMC safety data packages and act as the sponsor's safety representative in DMC interactions as appropriate.
• Drive integrated safety analyses supporting interim analyses, primary analysis, and BLA submission (including ISS, Summary of Clinical Safety, and safety narratives).
• Lead Safety Review Committee meetings and the ongoing review of adverse events of special interest.

Cell Therapy-Specific Safety

• Coordinate safety governance within the company and ensure cross-functional involvement in the evaluation of potential emerging safety issues and any associated risk mitigation and management measures.
• Provide safety leadership for cell therapy-specific risks including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), prolonged cytopenias, infections, IEC-HS, secondary malignancies, and replication-competent retrovirus/lentivirus monitoring where applicable.
• Ensure alignment with FDA guidance on cellular therapy long-term follow-up, and integrate long-term follow-up safety data into program-level safety surveillance.
• Partner with Clinical Development on protocol-specified risk mitigation (grading, management algorithms, stopping rules) and REMS considerations.

BLA & Regulatory Safety Deliverables

• Own the safety strategy and deliverables for the BLA, including Module 2.5/2.7.4 authoring or oversight, ISS strategy in partnership with Biostatistics, patient narratives, and the safety sections of the CSR.
• Support Pre-BLA and Type B/C meeting preparation, briefing document authoring, and follow-through on safety-related commitments.
• Prepare for Pre-License Inspection (PLI) and BIMO readiness for the pharmacovigilance system; own the Pharmacovigilance System Master File (PSMF) as the company scales toward approval.
• Plan for post-marketing pharmacovigilance obligations, including PADER/PSUR/PBRER, REMS (if applicable), and post-marketing safety studies.

Team Leadership & Cross-Functional Partnership

• Lead a small team of one to two direct reports — Safety Operations (case processing, compliance metrics, vendor oversight) and Safety Scientist (aggregate analyses, signal detection, authoring) — with hands-on mentoring and clear accountability.
• Scale the function thoughtfully as the program approaches BLA and launch; own hiring, structure, and role design.
• Partner closely with Clinical Development, Clinical Operations, Clinical Science, Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, Program Management, and Quality to ensure integrated safety execution.
• Build and maintain a fit-for-purpose drug safety and pharmacovigilance quality system, SOPs, and training program aligned with GVP and FDA expectations.

Qualifications

Required

• MD or DO degree with clinical practice experience.
• 10 years of drug safety / pharmacovigilance experience in the biotech or pharmaceutical industry, including leadership of the safety function for a late-stage or marketed product.
• Demonstrated experience owning safety deliverables for a major regulatory submission (BLA, NDA, or MAA), including ISS and Summary of Clinical Safety authoring or oversight.
• Direct experience with hematology/oncology programs; knowledge of internal medicine, hematologic malignancy experience is a plus.
• Working knowledge of cell therapy, or other advanced-therapy modalities and the unique safety considerations these products present (CRS, ICANS, long-term follow-up, etc.).
• Fluent in FDA regulations (21 CFR 312, 314, 600), ICH guidelines (E2A-E2F), GVP modules, MedDRA, and safety database systems (e.g., Argus, ARISg, RS Logix).
• Experience representing safety in health authority interactions and DSMB/IDMC meetings.
• Track record of building and leading small, high-performing safety teams and managing vendor partners.

Preferred

• Board eligibility or certification in a relevant medical specialty (e.g., hematology, oncology, internal medicine).
• Prior experience in a small or emerging biotech, including standing up or scaling a pharmacovigilance system.
• Experience preparing for and supporting PV inspections (FDA, EMA, or other).
• Familiarity with REMS design and post-marketing safety commitments.

Core Competencies

• Strong clinical and scientific judgment with the ability to make timely, well-reasoned safety decisions under uncertainty.
• Clear, calm communicator; able to translate complex safety data for executives, regulators, investigators, and cross-functional partners.
• Hands-on operator comfortable moving between strategy and day-to-day case-level work in a resource-constrained environment.
• Rigorous, detail-oriented, and inspection-minded, while maintaining a pragmatic bias for action.
• Collaborative leader who builds trust across functions and mentors a small team to grow with the program.

What We Offer

The opportunity to lead the safety function for a differentiated cell therapy through a registrational hematologic malignancy program and toward approval, inside a small team where your work directly affects patient outcomes. Competitive compensation including base salary, performance bonus, and meaningful equity; comprehensive benefits; and a collaborative culture built around patients with great medical need.

About KBIC Life Sciences

Kaye/Bassman's experienced pharmaceutical and biotechnology executive search team combines managing directors, partners, and tenured consultants who have exceptional industry and functional domain knowledge.

Because we were founded on the concept of Market Mastery™, each of our recruiters works in a specific functional domain that mirrors the departments of your company. Couple that with our Client Focused Search™ approach, the result is that you get the top talent hand delivered to you fast.