Associate Director, Medical Safety

Position Summary

The Associate Director, Medical Safety is responsible for medical and clinical oversight of individual case safety reports (ICSRs), signal detection and evaluation, and benefit-risk assessment for the company’s cell and gene therapy (CGT) / CRISPR-based product portfolio. Provides medical judgment across the case processing lifecycle (causality assessment, seriousness/expectedness, narrative review) with attention to gene-edited/vector-based safety (insertional oncogenesis, secondary malignancy, engraftment failure, and long-term follow-up).

Responsibilities

• Perform medical review of IC sRS: causality assessment, seriousness classification, expectedness determination vs. Investigator’s Brochure/labeling
• Provide clinical input on complex/ambiguous cases (e.g., secondary malignancy, graft failure, delayed engraftment, prolonged cytopenia, RCL)
• Review/approve case narratives for medical accuracy/completeness
• Serve as medical escalation point for UPESI
• Lead or contribute to signal detection per GVP Module IX (prioritization, validation, evaluation)
• Use disproportionality methods (PRR, ROR, EBGM) and benchmark against real-world cohort data where applicable
• Contribute medical safety content to DSURs and PBRER/PSURs and benefit-risk assessments
• Support risk characterization/mitigation with Safety Management Team/Safety Review Committee
• Maintain expertise in gene editing modalities and safety considerations (off-target editing, founder mosaicism)
• Oversee medical aspects of LTFU safety surveillance and integration site analysis follow-up
• Provide clinical input into vector-related safety monitoring (e.g., shedding, immunogenicity)
• Maintain PV SOPs; support inspections/audits; partner with Regulatory Affairs on safety submissions/queries
• Provide medical safety training; mentor junior safety staff

Minimum Qualifications

• MD/DO/PharmD (or equivalent); 6+ years PV/drug/clinical safety experience including ICSR medical review and causality assessment
• Working knowledge of global PV regulations (GVP, FDA reporting, ICH E2)
• Demonstrated experience in signal detection and aggregate safety reports (DSUR, PBRER/PSUR)
• Strong written/verbal communication for medically sound narratives and assessments

Preferred Qualifications

• Cell/gene therapy, CAR-T, or CRISPR safety oversight experience
• CAR-T toxicity grading (CRS/ICANS per ASTCT), LTFU program experience
• Board certification; DSMB/Safety Review Committee experience
• Familiarity with Argus, ArisGlobal, Veeva Vault Safety
• Travel 5–10%; availability outside business hours for urgent safety escalations

Compensation/Benefits

• Base pay range: $170,000 to $190,000+ plus bonus, equity and benefits