Associate Director, Medical Safety

CRISPR Therapeutics•South Boston, MA

2d•Hybrid

About The Position

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. This role provides medical judgment across the case processing lifecycle — causality assessment, seriousness and expectedness determination, and narrative review — with particular attention to the safety considerations unique to gene-edited and vector-based therapeutics, including insertional oncogenesis, secondary malignancy, engraftment failure, and long-term follow-up (LTFU) surveillance. The role sits at the intersection of clinical medicine, regulatory pharmacovigilance, and CGT-specific scientific expertise, and is expected to represent PV medical safety perspectives cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, and Manufacturing/Quality.

Requirements

MD, DO, PharmD, or equivalent advanced clinical degree
Minimum 6+ years of pharmacovigilance, drug safety, or clinical safety experience, including direct ICSR medical review and causality assessment
Working knowledge of global PV regulations and frameworks (GVP Modules, FDA safety reporting requirements, ICH E2 guidelines)
Demonstrated experience with signal detection methodology and aggregate safety report contribution (DSUR, PBRER/PSUR)
Strong written and verbal communication skills, with demonstrated ability to produce clear, medically sound case narratives and safety assessments

Nice To Haves

Prior experience in cell and gene therapy, CAR-T, or gene editing/CRISPR therapeutics safety oversight is nice to have
Familiarity with CAR-T-specific toxicity grading (CRS/ICANS per ASTCT consensus criteria)
Experience with long-term follow-up (LTFU) safety programs for gene therapy products
Board certification in a relevant clinical specialty (e.g., hematology/oncology, internal medicine)
Experience presenting to or supporting Data Safety Monitoring Boards (DSMBs) or Safety Review Committees
Familiarity with safety database platforms (Argus, ArisGlobal, Veeva Vault Safety)

Responsibilities

Perform medical review of ICSRs including causality assessment, seriousness classification, and expectedness determination against the current Investigator's Brochure / labeling
Provide clinical input on complex or ambiguous cases, particularly those involving secondary malignancy (e.g., MDS), graft failure, delayed engraftment, prolonged cytopenia, or replication-competent lentivirus (RCL) findings
Review and approve case narratives for medical accuracy and completeness prior to submission
Serve as a medical escalation point for Unanticipated Problems / Emerging Safety Issues (UPESI) identified during case review
Lead or contribute to signal detection activities per GVP Module IX, including signal prioritization, validation, and evaluation
Apply disproportionality analysis methods (PRR, ROR, EBGM) and benchmark observed events against real-world cohort data where applicable, particularly for oncologic and hematologic safety signals
Contribute medical safety content to aggregate safety reports (DSURs, PBRERs/PSURs) and benefit-risk assessments
Support the Safety Management Team / Safety Review Committee with medically-grounded risk characterization and mitigation recommendations
Maintain current expertise in gene editing modalities (CRISPR/Cas9, base/prime editing, HDR/NHEJ repair pathways) and their associated safety considerations, including off-target editing and founder mosaicism
Oversee medical aspects of long-term follow-up (LTFU) safety surveillance, including delayed-onset AEs and integration site analysis follow-up where applicable
Provide clinical input into vector-related safety monitoring (e.g., vector shedding, immunogenicity) in coordination with Clinical and CMC/Manufacturing teams
Contribute to and maintain PV SOPs relevant to medical safety review, signal management, and UPESI handling
Support inspection readiness and participate in internal audits and health authority inspections as a medical safety subject matter expert
Partner with Regulatory Affairs on safety-related regulatory submissions and health authority queries (FDA, EMA, PMDA/MHLW, NMPA/CDE)
Provide medical safety training to case processing staff, clinical operations, and investigator sites as needed
Mentor and provide medical guidance to junior case processing and safety staff, as applicable to team structure