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 experience preferred.
- Oncology experience required; cellular therapy, immunotherapy, biologics, urology, or prostate cancer experience strongly preferred.
- Proficiency with Microsoft Office and clinical trial systems such as CTMS, eTMF, EDC, and related platforms.
Working Conditions and Physical Requirements:- Office-based work with extended periods at a computer and frequent use of video conferencing and digital collaboration tools.
- Ability to occasionally lift up to 15 pounds.
- Domestic and/or international travel may be required for clinical sites, investigator meetings, vendors, audits, inspections, or company meetings.
- Occasional work outside normal business hours may be required to support clinical activities across time zones.
- Employees must be able to perform the essential functions of the position with or without reasonable accommodations.
CA Compensation Range
$181,030-$236,545 USD
