Associate 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 strong Research & Development group in Seattle, WA, and a highly skilled Commercial team across the nation, Dendreon is at the forefront of cancer treatment innovation.

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 Associate Director of Clinical Operations is responsible for the oversight, execution and management of clinical trial processes and document control for an ongoing phase III study, in prostate cancer, in accordance with study protocols, regulations and GCP guidelines. The successful candidate will also provide leadership, project management and program oversight to plan and conduct high quality clinical trials.

NOTE: This role requires on-site presence at our Seal Beach, CA location minimum 4 days per week.

• Execute and lead all operational aspects of clinical studies, including identification and management of contractors and third-party vendors, availability of clinical supply, trial planning, implementation, management and close-out.
• Provides oversight of clinical monitoring activities across investigational sites, ensuring data quality, protocol compliance, patient safety, and timely issue resolution.
• Lead clinical operations to ensure high quality clinical trial conduct using both internal clinical operations staff and/or contract research organizations.
• Collaborates with Clinical Immunology and Medical Affairs in the design, planning, and operational execution of clinical development and evaluation programs.
• Ensure studies are conducted in accordance with budget and the timely delivery of high-quality study data.
• Oversees clinical data quality and collaborates with Data Management and Biostatistics teams to ensure clinical data are accurate, complete, and inspection-ready.
• Identifies operational risks, develops mitigation strategies, and escalates critical issues to executive leadership as appropriate.
• Ensures clinical trials are conducted, documented, monitored, and reported in accordance with applicable SOPs, GCP guidelines, protocol requirements, and regulatory standards.
• Leads cross-functional study teams including Clinical Development, Medical Affairs, Regulatory Affairs, Biostatistics, Data Management, Quality, and external partners.
• Work collaboratively and in a cross functional manner with internal and external teams.
• Identify, qualify, audit, and manage all external vendors, including CROs. Take initiative to continually monitor external vendors in performance management, escalate issues where appropriate, and make appropriate changes in order to ensure compliant trial conduct and meet business objectives.
• Guarantee clinical trial team and clinical trial sites are properly trained and in compliance with company and/or CRO SOPs, CFR regulations, ICH GCP guidance, and study protocol.
• Provides strategic and operational oversight across one or more clinical studies and development programs, ensuring alignment with corporate objectives, timelines, budgets, and quality standards.
• Oversees study resource planning, forecasting, and allocation to support clinical program objectives.
• Identify gaps in Sponsor/CRO procedures and develop corrective and preventative actions as needed.
• Accountable for operational readiness and support of regulatory inspections, audits, and health authority inquiries related to assigned clinical programs.
• Identify, qualify, manage, and maintain relations with clinical trial sites, including collaborating with Principal Investigators and field team to support robust and compliant study performance, drive site selection, patient recruitment programs to deliver enrollment targets. Performs site monitoring with field team, as needed.
• Facilitate start-up activities including, but not limited to, investigational site contracts, investigational site, and ethics committee submissions, confidentiality agreements, negotiate study agreements and budgets with sites and external vendors.
• Oversee and approve clinical project deliverables such as scope definition documents, investigational product labeling, Pharmacy Manuals, informed consent forms, site activations, monitoring plan, CRFs, DMP, edit checks, safety plan, IDMC charter, close-out plans, and CSRs.
• Assist with the development of presentations, handouts, and coordination of Investigator Meetings.
• Ensure clinical trials are “audit ready” irrespective of study time point and that TMF-related documentation is current and comprehensive at CRO and sponsor locations throughout trial conduct.
• Prepare teams for study audits, and/or regulatory inspections and address findings appropriately and within specified timelines.
• Ensure that Senior Management and Leadership are appraised of study progress to goals and proposes corrections and/or improvements to advance study milestones.
• Ensure that all Clinical Affairs activities and initiatives are aligned with those of medical affairs and commercial functions and is compliant with corporate policies and regulatory requirements.
• Recruits, develops, coaches, and manages Clinical Operations personnel, fostering a culture of accountability, collaboration, and continuous improvement.

Scope:

• Develop and implement an approach to clinical trial execution that achieves a balance of cost, quality, and timelines.
• A deep understanding of the systems that support clinical trial execution, harnessing efficiencies and standards that enable business success.
• Possess strong and influential leadership skills with proven ability to lead internal and external team members.

• Bachelor's degree required; advanced scientific, clinical, or business degree preferred (MS, MPH, PharmD, PhD, RN, or MBA credentials).
• 8+ years of progressive clinical operations experience, including leadership of Phase I-IV clinical trials and management of CROs and external vendors.
• In-depth experience creating clinical development plans and conducting clinical trials.
• Must have a minimum of 5 years of experience with Phase I-IV trials, CRO management, and project and contract management.
• Experience managing and contributing toward the development of department strategy.
• Ability to direct actions of project teams and personnel as appropriate.
• In depth knowledge of ICH and GCP regulatory requirements.
• Experience with department budget planning, management and reconciliation.
• Demonstrated ability to work independently, effectively manage competing priorities and make appropriate strategic decisions to operationalize clinical trials.
• Excellent written and verbal communication skills.
• Excellent leadership, risk management, delegation, decision-making and documentation skills.
• Proficient in MS Office Applications.
• Commitment to working in a team oriented, cross-functional and collaborative manner.
• Ability to execute deliverables in a matrixed environment and adhere to corporate policy.
• Must have strong work ethic and be able to work independently and productively.

Working Conditions and Physical Requirements:

• Dendron Pharmaceuticals LLC is a EEO/AA employer M/F/D/V.
• Dendreon operates in a fast-paced, patient-centric, and competitive environment.
• Team cohesiveness, direct and specific communication, and independent problem-solving are essential to succeed in this position.
• Some travel required.
• While performing the duties of this job, the employee is regularly required to sit, stand, walk, and use hands to operate a computer keyboard, mouse, and mobile phone.