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. At Lyell, our goal is to change that. We are a clinical-stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for solid tumors based on our innovative technologies. 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 defeat solid tumors, 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 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. This role can be based in either South San Francisco, CA or Seattle, WA.

KEY ROLE AND RESPONSIBILITIES:

• Under guidance from the physician, drive the design and development of clinical trial protocols, ensuring they meet scientific, medical and regulatory requirements.
• Prepare and review documents for regulatory submissions (IND, BLA, etc.), including clinical study reports, Investigator’s Brochures, and responses to regulatory agency inquiries.
• Support the execution of clinical trials, ensuring adherence to the protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
• Coordinate with data management teams to ensure accurate data collection, analysis, and reporting. Review and interpret clinical data to make informed decisions about study progression.
• Monitor patient safety, identifying and managing adverse events, and ensuring timely reporting to regulatory bodies.
• Provide leadership and support to clinical operations, biostatistics, regulatory affairs, and other departments to ensure seamless trial execution; identify issues and recommend solutions for immediate action.
• Liaise with external stakeholders, including clinical research organizations (CROs), academic institutions, and key opinion leaders (KOLs); provide leadership and direction in identifying and solving issues to facilitate trial operations and maintain high standards of scientific integrity.
• Define opportunities for innovation and improvement in clinical trial methodologies and therapeutic approaches.
• Anticipate risk and proactively manage concerns; define actions to address issues in a timely manner.

PREFERRED EDUCATION:

• PhD or PharmD with a minimum of 15 years’ scientific and/or clinical experience in immunology, oncology, molecular biology, health care delivery, or
• MSc with a minimum of 17 years’ scientific and/or clinical experience in immunology, oncology, molecular biology, health care delivery, or
• BSRN with a minimum of 20 years’ scientific and/or clinical experience in immunology, oncology, molecular biology, health care delivery

PREFERRED EXPERIENCE:

• A minimum of 5 years’ experience in clinical development, with substantial experience in the pharmaceutical industry contributing to successful clinical programs.
• Phase 1 clinical trials experience.
• Demonstrated experience in 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.

 

We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.