Vice President, Medical Affairs, Clinical Operations & Regulatory Affairs

Overview 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-resistant 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. Core Values: 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. Job Summary:   The Vice President, Medical Affairs, Clinical Operations & Regulatory Affairs is responsible for the strategic leadership and oversight of the company's Medical Affairs, Clinical Operations and Regulatory Affairs functions. This executive role ensures alignment across scientific communications, product lifecycle management, clinical development, and regulatory strategy to support the successful development, approval, and commercialization of the company's products and contract manufacturing services (CMS) pipeline. 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. Responsibilities Medical Affairs Leadership (50%) Provide strategic oversight of Medical Affairs activities to ensure alignment between clinical development, regulatory strategy, and commercial objectives. Partner with Commercial leadership to ensure scientifically accurate and compliant communication regarding company products and pipeline programs. Develop and maintain strategic relationships with physicians, investigators, Key Opinion Leaders (KOLs), healthcare providers, and scientific experts to support clinical development, evidence generation, product adoption, and medical education initiatives.  Support development and review of scientific and medical content, including publications, congress presentations, medical education materials, and field medical resources. Oversee medical review of promotional and non-promotional materials to ensure scientific accuracy and regulatory compliance. Collaborate with Key Opinion Leaders (KOLs), investigators, and external scientific experts to support product development and lifecycle management. Support investigator-sponsored studies (ISS), real-world evidence initiatives, and post-marketing clinical activities. Provide medical and scientific leadership during regulatory submissions, advisory board meetings, and agency interactions. Ensure appropriate collection and communication of medical insights from healthcare providers and clinical stakeholders. Clinical Operations Leadership (30%) 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 of readiness and support regulatory inspections and audits. Drive continuous improvement initiatives to enhance operational efficiency and study execution. Regulatory Affairs Leadership (20%) 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. Executive Leadership Responsibilities Serve as a member of the senior leadership team, contributing to corporate strategy and organizational growth initiatives. Direct