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 oncogene sis, 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 recommendationsCGT-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…