Director, Clinical Operations

Dendreon Pharmaceuticals LLC; Seal Beach (CA); On-site; USD 181,000 - 237,000; Full time

Job summary

Dendreon Pharmaceuticals LLC in Seal Beach, CA seeks a Director, Clinical Operations to lead sponsor-side clinical studies, manage cross-functional teams, and ensure study quality and timelines.

You will oversee study plans, budgets, vendor relationships, and regulatory compliance, while developing SOPs and ensuring inspection readiness across programs such as PROVENGE.

Qualifications

• Bachelor’s degree in life sciences, nursing, pharmacy, or a related discipline; advanced degree preferred.
• Minimum 10 years of progressive clinical research or Clinical Operations experience, with sponsor-side leadership.
• Minimum 5 years leading clinical trials and cross-functional teams with CRO/vendor oversight.
• Experience overseeing monitoring strategy, TMF quality, and inspections.
• Oncology or related therapeutic area experience is strongly preferred.

Responsibilities

• Lead end-to-end clinical study execution from feasibility to archival, ensuring quality, enrollment, and timelines.
• Develop study plans, budgets, timelines, resources, and risk mitigation strategies.
• Directly manage Sr. CRAs/CRAs and other Clinical Operations personnel; set objectives and evaluate performance.
• Provide sponsor oversight of CROs, laboratories, and vendors; manage contracts and payments.
• Ensure protocol adherence, informed consent, and regulatory compliance; maintain inspection readiness.
• Collaborate with cross-functional teams to achieve study objectives and deliver robust data.
• Support data review, safety reporting, and delivery of timely clinical data.
• Develop and improve SOPs, templates, and scalable processes within Clinical Operations.

Skills

Clinical ops leadership

CRO oversight

Project management

Cross-functional leadership

CTMS proficiency

Oncology experience

MS Office

Education

Bachelor’s degree in life sciences or related field

Tools

CTMS

eTMF

EDC

Job description

At Dendreon,we’retransforming 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,utilizinga 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.

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 timelineobjectivesare 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 experiencerequired; 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

As set forth in Dendreon Pharmaceuticals LLC’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.