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 #J-18808-Ljbffr Scorpion Therapeutics