Senior Director of Clinical Operations
San Francisco, CA (Hybrid)
At this cutting-edge organization, they are at the forefront of scientific and technological advancements, dedicated to revolutionizing the treatment landscape for Oncology patients. They actively seek exceptional individuals to join our expanding team as we progress and enhance our pipeline.
A distinguishing feature of their approach is the integration of artificial intelligence (AI) to target traditionally harder-to-treat cancers with precision medicine and targeted therapies. Their commitment to innovation extends beyond conventional methods, as they harness the power of AI to enhance treatment efficacy and improve patient outcomes. As a key member reporting to the Head of Clinical Operations, you will play a crucial role in advancing these groundbreaking initiatives, contributing to the transformation of cancer care. Join them in shaping the future of Oncology treatment.
This role will be hybrid at their location in San Francisco. Must be willing to go into the office 2-3 days/week
Supervise and direct clinical trials, ensuring their timely completion within budget, and adherence to SOPs, FDA/EMA regulations, and ICH/GCP guidelines.
Act as the face of Clinical Operations ("ClinOps") in cross-functional study teams, Vendor, and CRO operational meetings, ensuring alignment with worldwide operational protocols.
Handle the selection, initiation, management, and supervision of various vendors, including CROs, imaging services, central and specialized labs, eCOA providers, and compliance partners.
Responsible for the review and oversight of tasks in study management plans for operations and all operational activities associated with clinical trials.
Review/approve invoices, manage monthly accruals, and ensure timely payment processing for vendors, including investigative sites (as applicable).
Possess over 15 years of experience in Clinical Operations or a related role, engaging with CROs and other vendors, and progressively assuming more significant roles.
Familiarity with FDA/EMA regulations and ICH/GCP guidelines is essential, accompanied by prior involvement in collaborative, cross-functional settings.
Proven track record in the selection, management, supervision, and fruitful cultivation of productive partnerships with multiple vendors and CROs.
Highly motivated and enjoys working in a fast-paced, dynamic environment
Strong organizational skills and ability to prioritize and multi-task
8 years of experience working in Oncology
Medical, Dental, Vision Insurance
Competitive salary, bonuses, and equity