Associate Director, Clinical Operations

Associate 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 is a hybrid role and can be based out of our Seattle, Washington office OR our South San Francisco, California office.

Position Summary :

The individual in this role will be accountable for leading the execution of assigned large / global complex Clinical Trial and manages the Clinical Operations staff assigned to the trial.

Key Role and Responsibilities :

• Defines and oversees trial plans that align with the defined strategy; sets plans and is accountable for day-to-day management actions and reporting of study progress to stakeholders
• Contributes to defining study strategy, interprets and implements the defined strategy; identifies operational feasibility issues and proposes solutions to address these concerns.
• Executes large / complex trials; primary point of contact for the CRO, leads the Study Management Team (SMT), but may delegate SMT responsibilities to more junior CTMs. May have some oversight of study execution for large, global studies and oversees regional CTMs who support study execution.
• Ensures the cross-functional team is aligned with tactics and plans; addresses issues and troubleshoots to ensure timelines and patient needs are achieved, escalates to the Director / Sr Director as needed for support
• Manages talent and develops capability for direct reports; models the Lyell Behaviors and provides timely and consistent feedback and coaching, manages performance and supports career progression for staff
• Supports TMF maintenance activities through timely filing of study and vendor documents. Trains study functional leads on roles and responsibilities related to TMF maintenance. Oversees TMF quality by assessing TMF related metrics and develops mitigation strategies to ensure TMF issues are addressed.
• Develops and recommends processes and procedures that support effective trial management suitable for the stage of the product / program
• Monitors and adheres to budget targets for their study

Preferred Education & Experience :