Vice President, Medical, Clinical & Regulatory Affairs

Vice President, Medical, Clinical & Regulatory Affairs

EPM Scientific is partnered with a commercial-stage biotechnology company seeking an executive leader to provide strategic and operational oversight across the organization. Reporting directly to the CEO and serving on the senior leadership team, the VP will drive medical strategy, clinical execution, and regulatory activities across a marketed immuno-oncology portfolio.

Location: Orange County, CA (on-site)

Responsibilities:

• Lead Medical Affairs activities including KOL engagement, scientific communications, publication planning, medical education, investigator-sponsored research, and review of promotional and non-promotional materials
• Oversee the planning and execution of clinical studies, including CRO and vendor management, study timelines and budgets, compliance, and inspection readiness activities
• Direct regulatory strategy and execution, including health authority interactions, submissions, and lifecycle management activities
• Partner closely with Commercial, Quality, Manufacturing, Pharmacovigilance, and other core functional leaders to support evidence generation and product adoption
• Build, develop, and oversee teams including Medical Information, MSLs, and Clinical Operations
• Represent the company with investigators, KOLs, regulators, and strategic partners
• Serve on the company's senior leadership team and contribute to business development strategy

Required Skills & Qualifications:

• MD, PharmD, or PhD is required; MD preferred
• 10+ years of Medical Affairs leadership experience within biotech or pharmaceutical companies
• Experience overseeing Clinical Operations and Regulatory Affairs teams and activities
• Oncology, cell therapy, or immunotherapy experience preferred
• Proven ability to lead cross-functional teams and influence at the executive level

Compensation & Benefits:

• Base salary: $260,000-$300,000
• 35% annual target bonus
• Comprehensive medical, vision, and dental insurance package
• 401(k) with company match
• Relocation assistance is available