Lyell Immunopharma
Senior Clinical Trial Management Associate
Lyell Immunopharma, Seattle, Washington, us, 98127
Senior Clinical Trial Management Associate
Seattle, Washington, United States The Lyell Immunopharma team is advancing next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. We seek a Senior Clinical Trial Management Associate who will execute defined tasks related to the execution of assigned clinical trial(s) in alignment with department and corporate goals, with guidance from the Director/Associate Director Clinical Operations or Senior Clinical Trial Manager. POSITION SUMMARY: The individual is responsible for executing defined tasks related to the execution of assigned clinical trial(s) based upon department and corporate goals and objectives; with the guidance from the Director/Associate Director Clinical Operations/Senior Clinical Trial Manager. KEY ROLE AND RESPONSIBILITIES: Completes trial related tasks with a high degree of autonomy Stepping into leadership scope including running Study Management meetings and managing vendor partnerships Develops tactical plans, detailed process steps and creates materials; recommends strategic inputs and proactively addresses problems with solutions Responsible for oversight of trial related tasks May take on CRO/vendor management for defined trial and/or more complex trial program activities; identifies issues and makes recommendations to mitigate issues in a timely manner Tracks inputs and deliverables day-to-day in partnership with the Clinical Operations team; seeks cross-functional follow-up to improve study progress Collaborates effectively; mentors and serves as a subject matter expert for more junior clinical team members Supports TMF maintenance activities through timely filing of study and vendor documents and assisting with TMF review Continues to learn and apply ICH GCP guidelines; stays current with evolving expectations and applies new protocols as required Tracks study expenses as directed; monitors budget targets for assigned vendors PREFERRED EDUCATION & EXPERIENCE: BS in Life Sciences or related discipline, with a minimum of 5 years’ experience Experience in Oncology clinical trial programs required Proven support of clinical studies for 3+ years; early phase and start-ups a plus Track record of collaborating with and managing CROs and external vendors to deliver successful trial outcomes Operates effectively in cross-functional, multi-disciplinary teams Understands FDA regulations and ICH GCP guidelines and applies them to studies to drive effective, efficient, and timely strategies Lyell offers compensation and benefits commensurate with experience. The salary range for this position is $128,000 to $160,000 annually, with opportunity for an annual bonus. Employees may participate in Lyell’s Equity Incentive Plan. Our benefits include medical, dental, vision plans, FSA, Life and AD&D insurance, STD/LTD, ESPP, 401(k) with company match, transit benefits, cell phone reimbursement, and paid time off.
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Seattle, Washington, United States The Lyell Immunopharma team is advancing next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. We seek a Senior Clinical Trial Management Associate who will execute defined tasks related to the execution of assigned clinical trial(s) in alignment with department and corporate goals, with guidance from the Director/Associate Director Clinical Operations or Senior Clinical Trial Manager. POSITION SUMMARY: The individual is responsible for executing defined tasks related to the execution of assigned clinical trial(s) based upon department and corporate goals and objectives; with the guidance from the Director/Associate Director Clinical Operations/Senior Clinical Trial Manager. KEY ROLE AND RESPONSIBILITIES: Completes trial related tasks with a high degree of autonomy Stepping into leadership scope including running Study Management meetings and managing vendor partnerships Develops tactical plans, detailed process steps and creates materials; recommends strategic inputs and proactively addresses problems with solutions Responsible for oversight of trial related tasks May take on CRO/vendor management for defined trial and/or more complex trial program activities; identifies issues and makes recommendations to mitigate issues in a timely manner Tracks inputs and deliverables day-to-day in partnership with the Clinical Operations team; seeks cross-functional follow-up to improve study progress Collaborates effectively; mentors and serves as a subject matter expert for more junior clinical team members Supports TMF maintenance activities through timely filing of study and vendor documents and assisting with TMF review Continues to learn and apply ICH GCP guidelines; stays current with evolving expectations and applies new protocols as required Tracks study expenses as directed; monitors budget targets for assigned vendors PREFERRED EDUCATION & EXPERIENCE: BS in Life Sciences or related discipline, with a minimum of 5 years’ experience Experience in Oncology clinical trial programs required Proven support of clinical studies for 3+ years; early phase and start-ups a plus Track record of collaborating with and managing CROs and external vendors to deliver successful trial outcomes Operates effectively in cross-functional, multi-disciplinary teams Understands FDA regulations and ICH GCP guidelines and applies them to studies to drive effective, efficient, and timely strategies Lyell offers compensation and benefits commensurate with experience. The salary range for this position is $128,000 to $160,000 annually, with opportunity for an annual bonus. Employees may participate in Lyell’s Equity Incentive Plan. Our benefits include medical, dental, vision plans, FSA, Life and AD&D insurance, STD/LTD, ESPP, 401(k) with company match, transit benefits, cell phone reimbursement, and paid time off.
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