Associate Director, Medical Safety

Job Description:

Company Overview

Founded over a decade ago, CRISPR Therapeutics is a leading biopharmaceutical company focused on developing transformative gene-based medicines for serious human diseases. The Company has evolved from a pioneering research-stage organization into an industry leader, marking a historic milestone with the approval of CASGEVY® (exagamglogene autotemcel [exa-cel]), the world’s first CRISPR-based therapy, approved for eligible patients with sickle cell disease and transfusion-dependent beta thalassemia. CRISPR Therapeutics is advancing a broad and diversified pipeline across hemoglobinopathies, cardiovascular, autoimmune, oncology, regenerative medicine and rare diseases. The Company continues to expand its leadership in gene editing through the development of SyNTase™ editing, a novel and proprietary gene-editing platform designed to enable precise, efficient, and scalable gene correction. To accelerate and expand its impact, CRISPR Therapeutics has established strategic collaborations with leading biopharmaceutical partners, including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California.

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

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

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