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.

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.

Beware of Recruitment Scams

Please be aware of the potential for scams from individuals, organizations and internet sites that claim to represent Dendreon Pharmaceuticals in recruitment activities. We strongly recommend that you verify all communications you receive about positions at Dendreon. Any communications from Dendreon would come from an email address that ends in “@dendreon.com”. Dendreon will never ask candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the recruitment or offer process. Dendreon conducts a formal recruitment process for all authorized positions posted and does not conduct interviews via social media, or other third-party sites or chat services. If you are unsure about a posting or email you receive, please contact us at AskHR@dendreon.com. If you believe you are a victim of fraud, please contact your local law enforcement.