Vice President, Medical Affairs, Clinical Operations & Regulatory Affairs

Who We Are

At Dendreon, we’re transforming the battle against cancer with personalized immunotherapy. Our flagship product, PROVENGE® (sipuleucel‑T), was the first FDA‑approved immunotherapy for metastatic castrate‑relevant prostate cancer, utilizing a patient’s own immune cells to fight the disease.

If you’re driven by the opportunity to make a meaningful impact on cancer patients' lives, we invite you to join our team. With Immunotherapy Manufacturing Facilities in Seal Beach, CA, and Union City, GA, a strong Research & Development group in Seattle, WA, and a highly skilled Commercial team across the nation, Dendreon is at the forefront of cancer treatment innovation.

• Put Patients First:
  Every day is an opportunity to improve the lives of those living with cancer.
• Act with Integrity:
  We commit to transparency, honesty, and always doing what’s right.
• Build Trust:
  Trust is earned through candid, open communication and a collaborative approach.
• Raise the Bar:
  We embrace continuous improvement and innovation, always striving to elevate our people.
• Drive Results:
  We are accountable to each other and deliver success together.

The Vice President, Regulatory Affairs, Clinical Operations & Medical Affairs is responsible for the strategic leadership and oversight of the company's Regulatory Affairs, Clinical Operations, and Medical Affairs functions. This executive role ensures alignment across clinical development, regulatory strategy, scientific communications, and product lifecycle management to support the successful development, approval, and commercialization of the company's products.

The Vice President serves as a key member of the senior leadership team and works cross‑functionally with Quality, Manufacturing, Commercial, Finance, and Executive Leadership to advance corporate objectives while ensuring compliance with applicable regulatory and industry standards.

NOTE: This role requires on‑site presence at our Seal Beach, CA location minimum 4 days per week.

• Develop and execute global regulatory strategies supporting product development, clinical studies, manufacturing changes, and commercialization initiatives.
• Lead preparation, submission, and maintenance of regulatory filings, including INDs, BLAs, amendments, supplements, annual reports, and other regulatory submissions.
• Serve as the primary liaison with regulatory agencies, including the U.S. Food and Drug Administration and international health authorities.
• Provide regulatory guidance and risk assessments to executive leadership, project teams, and functional departments.
• Ensure compliance with applicable regulations, guidance documents, and industry standards.
• Monitor evolving regulatory requirements and assess business impact.
• Lead regulatory interactions, meetings, inspections, audits, and responses to agency inquiries.
• Support due diligence activities, licensing opportunities, partnerships, and strategic business initiatives.
• Establish and maintain regulatory policies, procedures, and best practices.
• Oversee regulatory intelligence activities and communicate emerging trends to leadership.

• Provide strategic oversight for the planning, execution, monitoring, and reporting of clinical trials.
• Lead Clinical Operations teams, CROs, vendors, and study partners to ensure successful delivery of clinical programs.
• Develop and implement clinical operational strategies that align with regulatory and corporate objectives.
• Oversee study timelines, budgets, resource allocation, and risk management activities.
• Ensure clinical studies are conducted in compliance with GCP, ICH guidelines, protocol requirements, and applicable regulations.
• Collaborate with Medical Affairs, Regulatory Affairs, Quality, Biostatistics, Data Management, and Pharmacovigilance functions.
• Monitor study performance metrics and implement corrective actions when necessary.
• Support clinical site selection, startup activities, enrollment strategies, and study closeout activities.
• Ensure inspection readiness and support regulatory inspections and audits.
• Drive continuous improvement…