Director, Clinical Operations

Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response. We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency. This role can be based out of either our South San Francisco, CA or Seattle, WA offices. The incumbent will lead a program anticipated to grow to include multiple trials. This role will oversee the teams involved in the trials. KEY ROLE AND RESPONSIBILITIES: Leads the development of strategic planning for assigned clinical trial portfolio including timelines, budgets and resourcing (internal and external) Oversight of operational feasibility; making decisions on recommendations and solutions to align with study and patient needs Oversees study execution; manages risks in timeline, budget and quality, advises the team on actions to mitigate these risks Ensures the cross-functional team is aligned with tactics and plans; addresses issues directly to resolve concerns Leads the development of talent; ensuring coaching and performance management is conducted in a timely Guides leaders in talent management. Models the Lyell Leader Behaviors. Supports TMF maintenance activities through timely filing of study and vendor documents as needed. Oversees TMF quality by reviewing TMF health and works with CTM to develop mitigation strategies to ensure TMF issues are Escalates any TMF-related needs (vendors, systems) to senior leadership as needed, to support TMF health. Develops the department; collaborates with VP Clinical Operations to ensure processes and procedures are in place as needed for the maturity of the Effectively manages budgets and resources to meet goals and PREFERRED EDUCATION: BSc with a minimum of 17 years' experience MSc with a minimum of 14 years' experience PREFERRED EXPERIENCE: A minimum of 8 years' experience in Oncology drug development and cell therapy experience A minimum of 3 years' experience in early-stage drug programs Proven experience in the design and development of clinical trial program Prior experience with BLA submissions and regulatory authority inspections desirable KNOWLEDGE, SKILLS AND ABILITIES: Demonstrated knowledge of collaborating and managing CROs and other external vendors to deliver successful trial outcomes Proven ability to lead broad clinical operations teams and effectively lead cross-functional study execution teams Has in depth understanding of FDA regulations and ICH GCP guidelines; successfully applied these to studies to drive effective, efficient and timely strategies Lyell offers its employees a range of compensation and benefits. The salary range for this position is $200,000 to $240,000, annually, with the opportu