Vice President Medical Affairs, Regulatory Affairs & Clin Operations (oncology)

Title: Vice President, Medical Affairs, Regulatory Affairs & Clinical Operations (Oncology)

FT or PT: Full-Time, Onsite (no flexibility)

Location: Orange County, CA

Kelly® Science & Clinical is seeking a Vice President, Medical Affairs, Clinical Operations & Regulatory Affairs for a direct-hire executive leadership role at our client, an innovative, patient-focused biotechnology company. If you are passionate about advancing cancer therapies and leading multidisciplinary teams to deliver impactful results, trust The Experts at Hiring Experts to help elevate your career.

In this high-impact position, you will be responsible for strategic leadership and oversight of Regulatory Affairs, Clinical Operations, and Medical Affairs functions. You will develop and execute global regulatory strategies, oversee clinical trial operations, and provide medical leadership that supports clinical development, regulatory submissions, and commercialization across multiple programs. Your role ensures cross-functional alignment with key internal and external stakeholders, compliance with global regulatory requirements, and continuous innovation in a fast-paced environment.

Key Responsibilities:

• Develop and implement global regulatory strategies for product development, clinical studies, manufacturing changes, and commercialization.
• Lead preparation and maintenance of regulatory submissions (INDs, BLAs, amendments, supplements, annual reports).
• Serve as the primary liaison with regulatory agencies and provide guidance to executive leadership.
• Provide strategic oversight of clinical trial planning, execution, oversight of CROs/vendors, and performance metrics.
• Ensure operational excellence and compliance with GCP, ICH guidelines, protocols, and regulations.
• Develop clinical operational strategies, support site selection, and drive study enrollment.
• Lead Medical Affairs functions by building strategic partnerships with Key Opinion Leaders (KOLs), guiding scientific communications, and supporting evidence generation, medical education, and post-marketing activities.
• Collaborate cross-functionally across Research, Development, Quality, Commercial, and Executive Leadership teams.
• Manage, coach, and develop functional teams, oversee departmental budgets, and foster a culture of compliance, innovation, and results.

Requirements:

• Advanced degree (MS, PharmD, PhD, MD, or equivalent); medical degree preferred but not required.
• Minimum 15 years of progressive leadership experience in biotechnology, pharmaceuticals, or related fields.
• Minimum 10 years of experience in Regulatory and Medical Affairs leadership.
• Significant experience overseeing Clinical Operations, clinical trial execution, and Medical Affairs.
• Demonstrated success in regulatory submissions, agency interactions, and supporting products through commercialization.
• Expert knowledge of FDA regulations, ICH guidelines, GCP, GMP, and global regulatory requirements.
• Proven ability to lead cross-functional teams, drive organizational growth, and operate in a fast-paced, highly regulated environment.
• Up to 30% travel (domestic/international) required.