Senior Manager, Drug Safety

Salary Range: $ To $ Annually

Blossom Hill Therapeutics, Inc. is a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to develop innovative small molecule medicines which address significant unmet medical needs in cancer treatment. Founded and led by industry veteran J. Jean Cui, Ph.D., with her proven track record in oncology drug design and development - including three FDA-approved drugs - Blossom Hill applies cutting-edge science to address key oncogenic drivers and improve patient outcomes in difficult-to-treat cancers.

The company’s lead clinical programs include BH-30643, a first-in-class, macrocyclic, non-covalent, mutant-selective OMNI-EGFRTM inhibitor for the treatment of EGFR-mutated non-small cell lung cancer, BH-30236, a macrocyclic CLK inhibitor for the treatment of relapsed or refractory acute myeloid leukemia or higher-risk myelodysplastic syndrome and BH-501284, a non-covalent, pan-KRAS inhibitor for treatment of diverse KRAS-mutant tumors.

The Senior Manager, Drug Safety will play a key role in supporting the company’s drug safety and pharmacovigilance activities. This hands-on role will provide clinical, scientific, and operational expertise in the identification, assessment, documentation, and management of safety information arising from clinical trials.

The successful candidate will have progressive, hands-on drug safety/pharmacovigilance experience and a strong understanding of clinical safety principles, global regulatory requirements, safety surveillance, and outsourced pharmacovigilance operations. The role will collaborate closely with Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Data Management, and other cross-functional teams to ensure timely, compliant, and high-quality safety assessment and reporting.

The ideal candidate will bring a clinical background, with a nursing degree preferred, combined with hands-on experience in drug safety and the ability to work effectively in a dynamic, development-stage oncology environment.

This is an onsite role based in our San Diego office.

• Support and provide clinical expertise across drug safety and pharmacovigilance activities for oncology clinical development programs.
• Manage end-to-end SAE operations, including CRO management for case intake, triage, case review, follow-up, regulatory reporting, clinical database reconciliation, escalation, and closure of safety information.
• Oversee case processing activities, including MedDRA coding, narrative development, quality control, medical review workflow, case distribution, and compliance with applicable reporting timelines and procedures.
• Contribute to the submission of expedited safety reports, DSURs and other aggregate reports, and related pharmacovigilance deliverables.
• Support clinical trial safety activities, including review of aggregate safety data, safety listings, relevant safety analyses, and clinical trial safety documentation.
• Collaborate with Clinical Development and Clinical Operations on safety-related aspects of clinical trials, including SAE review, safety data reconciliation, and ongoing benefit-risk assessment.
• Contribute to the development and maintenance of safety-related processes, procedures, work instructions, and safety management plans.
• Support safety input into clinical study protocols, informed consent documents, investigator materials, and other clinical development documents as appropriate.
• Participate in cross-functional safety review meetings and communicate clinically relevant safety findings and recommendations to internal stakeholders.
• Provide day-to-day oversight of external pharmacovigilance vendors/CROs, including…