Director, Clinical Science

 

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 Seattle, WA or South San Francisco, CA offices.

The incumbent will partner with the physician to ensure that protocols are developed and in place for all clinical trials. This role is responsible for ensuring that all clinical trials are monitored for patient safety and regulatory guideline adherence.

KEY ROLE AND RESPONSIBILITIES:

• Collaborate in the design and development of clinical trial protocols, ensuring they meet scientific, medical, and regulatory requirements, including selection of endpoints and patient populations.
• Support and contribute to preparation and review of documents for regulatory submissions (IND, BLA, etc.), including clinical study reports, Investigator’s Brochures, and responses to regulatory agency inquiries.
• Partner with the medical monitor to support the execution of clinical trials, ensuring adherence to the protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
• Coordinate cross-functionally with the study team to ensure accurate and timely data collection, analysis, and reporting. Assist with review and interpretation of clinical and translational data to make informed decisions about study execution.
• Support patient safety monitoring by partnering with the medical monitor to identify and support site management of adverse events per protocol requirements and required timely reporting to regulatory bodies.
• Collaborate with clinical operations, biostatistics, data management, pharmacovigilance, regulatory affairs, translational medicine, medical affairs, and other departments to ensure seamless trial execution.
• Contribute to regularly planned and ad hoc interactions with external stakeholders and vendors, including study site investigators and staff, steering committees, Safety/Data Monitoring Committees, key opinion leaders (KOLs), and Contract Research Organizations (CROs) to collaboratively identify issues and solutions, facilitate trial operations and patient enrollment, and maintain high standards of scientific integrity.
• Identify opportunities for innovation and improvement in clinical trial methodologies and therapeutic approaches.
• Consistently monitor for risks, recommend actions to address issues in a timely manner.

PREFERRED EDUCATION:

• PhD, PharmD, PA-C, ARNP, MS, BSRN, in a related field

 

PREFERRED EXPERIENCE:

• 10+ years related experience delivering results in a clinical, research or pharmaceutical organization
•  A minimum of 4 years’ experience in clinical development, with 7+ years related experience, ideally in oncology, with a focus on cell therapy, T-cell engager, or immuno-oncology.
• Demonstrated experience in supporting the design, execution, and oversight of clinical trials.

KNOWLEDGE, SKILLS AND ABILITIES:

• Strong analytical, organizational, and communication skills.
• Ability to lead program/project teams effectively in a collaborative, fast-paced environment.
• Ability to manage multiple priorities in a fast-paced, dynamic environment.

 

 

At Lyell, we believe that highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.