Senior Director/VP Regulatory Affairs

Senior Director/VP Regulatory Affairs – Immuno-Oncology Biotech
Location: Bay Area, CA (hybrid)
Salary: $270k - $350k + bonus + benefits

Warman O’Brien is partnering with a biotech advancing innovative therapies in immuno-oncology. The company is seeking a senior regulatory leader to shape and drive global regulatory strategy across its pipeline of innovative therapies.

Key Responsibilities

• Lead regulatory strategy from pre-IND through clinical development.

• Drive FDA/EMA interactions and secure regulatory designations where appropriate.

• Partner cross-functionally with clinical, CMC, and nonclinical teams to deliver IND/CTA submissions.

• Operate effectively in a lean, outsourced model (CRO/CDMO).

• Provide strategic leadership to the executive team and build scalable regulatory processes.

Ideal Profile

• Proven track record leading IND/CTA submissions and global agency interactions.

• Strong development-stage background in biologics (monoclonal antibodies, recombinant proteins, peptides, etc.).

• Experience in autoimmune disease is a plus.

• Comfortable working in small, fast-moving biotech environments.

• Ability to translate cutting-edge science into clear regulatory strategy.

• Confident leader able to build regulatory functions from the ground up.