Director, Clinical Operations

Dendreon Pharmaceuticals LLC•Seal Beach, CA

3d•$181,030 - $236,545•Onsite

About The Position

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.

Requirements

Bachelor’s degree in life sciences, nursing, pharmacy, or a related discipline, or an equivalent combination of education and relevant 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 experience preferred.
Oncology experience required
Proficiency with Microsoft Office and clinical trial systems such as CTMS, eTMF, EDC, and related platforms.

Nice To Haves

Advanced scientific or clinical degree preferred.
Cellular therapy, immunotherapy, biologics, urology, or prostate cancer experience strongly preferred.

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.