Clinical Trial Assistant

Lyell Immunopharma; Seattle (WA); On-site; USD 59,000 - 69,000; Full time

Benefits offered by this job

Equity Incentive Plan

Job summary

Lyell Immunopharma is seeking a Clinical Trial Support professional to assist in executing assigned study tasks and to help maintain TMF documentation across vendors. You will collaborate with the Clinical Operations team and cross-functional partners to ensure timely data collection and issue resolution.

The role requires familiarity with FDA regulations and ICH GCP guidelines, with preference for experience in oncology drug development and early-phase studies.

Qualifications

• BSc with 7+ years of experience required.
• MSc with 4+ years of experience required.

Responsibilities

• Conducts trial support activities as assigned, escalates issues and recommends solutions to address concerns.
• Supports drafting of study plans, process documents and creates forms as needed for efficient trial execution; collaborates with broader study team stakeholders to improve recommendations.
• Collects and collates data from CRO/vendors, as assigned by Manager, Clinical Trials or Associate, Clinical Trials Management, reports data to stakeholders as needed, raises any issues to study lead quickly for timely resolution.
• 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.
• Becomes subject matter expert in trial master file (TMF) requirements and conducts TMF review, reporting findings. Works with CRO and other vendors to support TMF maintenance by providing study documents when TMF resides with vendor.
• Learns and applies ICH GCP guidelines; stays current with evolving expectations and applies new protocols as required
• Tracks study expenses, as directed, tracks vendor or site invoices, routes invoices for

Skills

Cross-functional study delivery

Cross-functional teams

FDA regulations

ICH GCP guidelines

TMF knowledge

Vendor coordination

Education

BSc with 7+ years experience

MSc with 4+ years experience

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. 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.

The incumbent will support the execution of assigned clinical study tasks.

KEY ROLE AND RESPONSIBILITIES:

• Conducts trial support activities as assigned, escalates issues and recommends solutions to address concerns.
• Supports drafting of study plans, process documents and creates forms as needed for efficient trial execution; collaborates and seeks feedback from broader study team stakeholders to improve/optimize recommendations
• Collects and collates data from CRO/vendors, as assigned by Manager, Clinical Trials or Associate, Clinical Trials Management, reports data to stakeholders as needed, raises any issues to study lead quickly for timely resolution
• 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.
• Becomes subject matter expert in trial master file (TMF) requirements and conducts TMF review, reporting findings. Works with CRO and other vendors to support TMF maintenance by providing study documents when TMF resides with vendor.
• Learns and applies ICH GCP guidelines; stays current with evolving expectations and applies new protocols as required
• Tracks study expenses, as directed, tracks vendor or site invoices, routes invoices for

PREFERRED EDUCATION:

• BSc with a minimum of 7 years' experience
• MSc with a minimum of 4 years' experience

PREFERRED EXPERIENCE:

• Entry-level support experience of clinical studies with some Life Sciences industry experience
• Demonstrated experience with field/site monitoring, and/or sponsor in-house, and/or Oncology drug development
• Proven experience supporting clinical studies for early phase and start-ups

KNOWLEDGE, SKILLS AND ABILITIES:

• Ability to continually develop an understanding of cross functional study delivery, CRO and other external vendor scope to deliver successful trial outcomes
• Ability to operate effectively in cross-functional, multi-disciplinary teams
• Demonstrated understanding of FDA regulations and ICH GCP guideline with an ability to successfully apply these to studies to drive effective, efficient and timely strategies

The salary range for this position is $43.27 to $50.00 hourly, 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 applicant’s qualifications and experience. Employees are also eligible to participate in Lyell’s Equity Incentive Plan.

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.

If you are hired, you will be required to come onsite to your assigned Lyell office on a regular basis. Our locations are as follows: 201 Haskins Way, South San Francisco, CA 94080; 500 Fairview Ave N, Seattle, WA 98109; 2525 223rd St SE, Bothell, WA 98021.