Senior Director, Clinical Operations

Role: Senior Director of Clinical Operations leading global clinical programs for innovative T-cell engager therapies in immunology and oncology. Responsibilities include strategic planning, resource management, and execution of clinical trials from IND-enabling through Phase 3, ensuring compliance with ICH-GCP, FDA regulations, and SOPs. The role involves cross-functional collaboration with senior leadership, external partners (CROs, labs, advocacy groups), and investigator relationships, alongside developing operational standards and KPIs. Mentoring and developing clinical operations staff, overseeing trial documentation, budgets, timelines, and ensuring regulatory adherence are key duties. Qualifications: Bachelor’s in life sciences with 12+ years in clinical research, including 10+ years in trial management, with expertise in autoimmune indications and early-phase studies. Strong knowledge of regulatory guidelines, clinical trial systems (CTMS, EDC), and budget management required. Preferred: advanced degree and experience in immunology or oncology. High-value specifics: focus on immunology and oncology indications, biologics or cell therapies, late preclinical to Phase 3 stages, global operational leadership, and stakeholder engagement. Work setup: hybrid in San Diego, with up to 25% travel. Reporting to the VP, Clinical Operations.