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.

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.

• 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

• Contri…