Associate, Clinical Trial Management

Lyell Immunopharma; Seattle (WA); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Equity Incentive Plan

Job summary

Lyell Immunopharma is seeking an experienced Clinical Operations professional to manage oncology trial activities, coordinate with CROs, and ensure adherence to ICH GCP and FDA regulations. The role supports TMF processes, tracks study progress, and mentors junior team members in a fast-paced, start-up-like environment.

The position requires 4+ years in clinical operations, with a BS in Life Sciences; preference for early-phase and cross-functional program experience.

Qualifications

• Experience in Oncology clinical trial programs required.
• Proven support of clinical studies for 2+ years; early phase and start-ups 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.

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.

Skills

Oncology clinical trial experience

CRO/vendor management

Cross-functional collaboration

FDA regulations knowledge

ICH GCP guidelines

Clinical operations coordination

Education

BS in Life Sciences

Tools

CTMS

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
• 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

The salary range for this position is $100,000 to $130,000, annually, 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.

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

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Lyell Immunopharma’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.