Director, Clinical Operations

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 talented team of scientific, clinical, regulatory, and corporate professionals based in Seal Beach, and a commercial organization operating across the United States, Dendreon continues to advance innovation in personalized cancer treatment. 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 Director, Clinical Operations, provides strategic and operational leadership for Dendreon-sponsored clinical programs and studies such as supporting PROVENGE® (sipuleucel-T), lifecycle management, and other company priorities. The Director is accountable for study planning and execution, sponsor oversight, quality, compliance, timelines, enrollment, budgets, and inspection readiness. This role leads cross-functional study teams and external partners and directly manages and develops Senior Clinical Research Associates (Sr. CRAs), Clinical Research Associates (CRAs), and/or other Clinical Operations personnel. NOTE: This role requires on site presence in our Seal Beach location 5 days per week. Key Responsibilities :

Lead end-to-end clinical study execution from feasibility and startup through database lock, closeout, and archival, ensuring quality, compliance, enrollment, budget, and timeline objectives are met. Develop and manage study plans, timelines, budgets, resource strategies, enrollment forecasts, performance metrics, and risk-mitigation or recovery plans. Lead cross-functional study teams, establish clear governance and accountability, resolve operational issues, and communicate risks, tradeoffs, and recommendations to senior leadership. Directly manage, coach, and develop Sr. CRAs, CRAs, and other Clinical Operations personnel; set objectives, assign work, evaluate performance, and maintain appropriate monitoring capacity and coverage. Oversee monitoring strategy and CRA activities, including site qualification, initiation, interim monitoring, co-monitoring, visit-report review, issue escalation, and closeout. Provide sponsor oversight of CROs, laboratories, clinical sites, investigators, consultants, and specialty vendors, including selection, qualification, contracting, governance, performance management, and corrective action. Oversee site feasibility, activation, training, recruitment and retention, investigational product/accountability interfaces, protocol compliance, and site closeout. Ensure compliance with protocols, informed-consent requirements, company procedures, GCP, ICH guidelines, and applicable regulations; maintain inspection-ready trial documentation and TMF quality. Partner with Quality to prepare teams, sites, and vendors for audits and inspections and ensure timely resolution of findings, deviations, and corrective and preventive actions. Lead or contribute to protocols, informed consent forms, monitoring and vendor plans, study manuals, case report forms, data and safety plans, clinical study reports, and other essential documents. Collaborate with Clinical Development, Medical Affairs, Regulatory Affairs, Quality, Data Management, Biostatistics, Pharmacovigilance, Clinical Immunology, Manufacturing, Patient Operations, Finance, Legal, and Procurement to achieve study objectives. Support data review, query resolution, reconciliation, safety reporting, database lock, and delivery of accurate, timely clinical data. Manage study and departmental budgets, forecasts, contracts, change orders, invoices, accruals, and resource plans. Develop and improve Clinical Operations SOPs, systems, templates, training, metrics, and scalable processes; represent Clinical Operations in governance, investigator, vendor, and regulatory forums. Perform other responsibilities consistent with the position and business needs.

Job Requirements: Education

Bachelor’s degree in life sciences, nursing, pharmacy, or a related discipline, or an equivalent combination of education and relevant experience; advanced scientific or clinical degree preferred.

Required Experience

Minimum 10 years of progressive clinical research or Clinical Operations experience in the biotechnology or pharmaceutical industry, including significant sponsor-side study leadership. Minimum 5 years leading clinical trials and cross-functional teams, with responsibility for CRO/vendor oversight, project management, contracts, budgets, and study delivery. Proven people-management experience, including direct leadership, coaching, development, and performance management of Sr. CRAs, CRAs, and/or other Clinical Operations professionals. Experience overseeing monitoring strategy, site management, TMF quality, inspection readiness, and resolution of operational or compliance issues. Experience supporting clinical development plans and studies across one or more phases; Phase I through IV and post-marketing/lifecycle-management experi