Senior Manager, Clinical Trials

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.  

POSITION SUMMARY: 

The individual in this role is responsible for leading the execution of assigned clinical trial(s) based upon department and corporate goals and objectives and manages Clinical Operations staff assigned to the trial. 

 KEY ROLE AND RESPONSIBILITIES:  

• Defines trial plans that align with the defined strategy; sets plans and is accountable for day-to-day management actions 
• Interprets and implements the defined strategy; identifies operational feasibility issues and proposes solutions to address these concerns 
• Executes the trial; primary point of contact for the CRO, leads the Study Management Team (SMT)
• Ensures the cross-functional team is aligned with tactics and plans; addresses issue 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:  

• BS in Life Sciences, or related discipline with a minimum of 7 years of experience  
• Track record of successful delivery clinical trial timelines and budgets 
• Must have two+ years of management of clinical trial programs for early-stage products
• Oncology drug development experience required; plus, to have cell therapy experience
• Track record of collaborating and managing CROs and other external vendors to deliver successful trial outcomes
• Effectively leading cross-functional study management 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. To assist you with your decision to apply for this role, the following decision to apply for this role, the following information and links to our site highlight our competitive market position and support to our employees and their dependents.   The salary range for this position is $148,000 to $185,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell’s compensation practices and an appli