Job Description:

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. 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.

Responsibilities

Case Safety & Medical Review

• 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

Signal Detection & Benefit-Risk

• 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

CGT-Specific Safety Oversight

• 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

Process, Compliance & Cross-Functional Collaboration

• 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

Minimum Qualifications

• 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

Preferred Qualifications

• 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)
• Standard office environment; occasional travel (domestic/international) for audits, inspections, or scientific conferences (estimated 5-10%)
• May require availability outside standard business hours for urgent safety escalations (e.g., serious AESI review, expedited reporting deadlines)

Competencies

• Collaborative - Openness, One Team
• Undaunted - Fearless, Can-do attitude
• Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems.
• Entrepreneurial Spirit - Proactive. Ownership mindset.

CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site.

Associate Director, Medical Safety: Base pay range of $170,000 to $190,000+ bonus, equity and benefits