Quick Overview
Job Description
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 incumbent is responsible for conducting tasks related to the trial, as assigned; escalates issues and recommends solutions to address concerns; with the guidance from the Director/Associate Director Clinical Operations/Senior Clinical Trial Manager.
KEY ROLE AND RESPONSIBILITIES:
- Conducts tasks related to the trial as assigned; escalates issues and recommends solutions to address concerns
- Develops tactical plans, detailed process steps and creates forms as needed for efficient trial execution; collaborates and seeks feedback from broader study team stakeholders to improve/optimize recommendations
- Responsible for oversight of defined tasks with CRO partners; ensures deliverables are conducted on a timely, quality basis. Raises issues quickly to CTM/Sr CTM for resolution; makes recommendations on how to address concerns
- Tracks inputs and deliverables day-to-day in partnership with the Clinical Operations team; identifies ways to improve the way we track study progress, reaches out to cross-functional partners for follow up and pull through.
- Collaborates effectively; operates as a mentor and subject matter expert for more junior clinical team members
- Supports TMF maintenance activities through timely filing of study and vendor documents, assisting with TMF review, reporting findings to CTM
- Continues to learn and apply ICH GCP guidelines; stays current with evolving expectations and applies new protocols as required; recommends processes and procedures that support effective trial management
- Tracks study expenses, as directed by Associate Director or Sr CTM, tracks vendor invoices, routes invoices for approval.
PREFERRED EDUCATION:
- BS in Life Sciences, or related discipline
PREFERRED EXPERIENCE:
- Minimum 4 years
KNOWLEDGE, SKILLS AND ABILITIES:
- Experience in Oncology clinical trial programs required
- Proven support of clinical studies for 2+ years; early phase and start-ups a plus
- Field/site monitoring experience a plus; sponsor in-house experience a plus, Oncology drug development experience a plus
- Track record of collaborating and managing CROs and other external vendors to deliver successful trial outcomes
- Operates effectively in cross-functional, multi-disciplinary teams
- Understands FDA regulations and ICH GCP guidelines; learns how to successfully apply these to studies to drive effective, efficient and timely strategies