Clinical Development Program Management

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. 

 

The Associate Director/Director, Clinical Development Program Management is a senior leadership role responsible for driving the strategic and operational execution of one or more clinical development programs from early- through late-stage trials. This individual will serve as a central point of accountability for cross-functional program delivery, a primary partner for  Core Team and workstream Program Owners for Lyell’s asset(s).  As part of this partnership, the Program Manager ensure priorities are met by understanding the clinical development process and status across the matrix team structure.  S/he identifies potential obstacles, identifying options and solutions in partnership with the Program Owner.  This individual works closely with Core Team Leads, Clinical Development, CMC, Regulatory Affairs, Biometrics, Quality, Pharmacovigilance, and external partners (CROs/vendors) to ensure trials and programs are delivered on time, within budget, and in compliance with GCP and applicable regulatory requirements.

This role requires a proven track record of leading complex, matrixed teams supporting Clinical Trials through approval and life cycle management. This individual translates clinical strategy into actionable operational plans, and anticipates and works to mitigate risk across the development lifecycle — including, where applicable, contributing to regulatory submissions supporting marketing approval (e.g., BLA/NDA).