Director, Clinical Operations
- Compensation
- Not disclosed
- Location
- Seal Beach, California, United States
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Not specified
- Experience
- 5+ years
- Category
- Not specified
- Posted
Skills
Must have
- 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.
Full description
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.
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.