Lyell Immunopharma
Senior Clinical Trial Management Associate
Lyell Immunopharma, Seattle, Washington, us, 98127
Overview
Senior Clinical Trial Management Associate 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. Lyell is advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. The company’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness to drive durable tumor cytotoxicity and long-lasting clinical response. We were founded by cell therapy pioneers and 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 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 guidance from the Director/Associate Director Clinical Operations/Senior Clinical Trial Manager. Responsibilities
Completes trial related tasks with a high degree of autonomy Able to step into leadership scope including running Study Management meetings and managing vendor partnerships Develops tactical plans, detailed process steps and creates materials in addition to recommending strategic inputs and addressing problems with solutions Responsible for oversight of trial related tasks May take on CRO/vendor management for the defined trial and/or more complex trial program activities, ensuring deliverables are conducted on a timely, quality basis; identifies issues and makes recommendations to mitigate issues Tracks inputs and deliverables day-to-day in partnership with the Clinical Operations team; identifies ways to improve study progress, cross-functional follow up and pull through Collaborates effectively; mentors and serves as a subject matter expert for more junior clinical team members Supports TMF maintenance through timely filing of study and vendor documents, 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, monitors vendor invoices, and adheres to budget targets for assigned vendors Qualifications
BS in Life Sciences or related discipline, with a minimum of 5 years’ experience; or related discipline Experience in Oncology clinical trial programs required 3+ years of experience supporting clinical studies; early phase and start-ups a plus Track record of collaborating with and managing CROs and external vendors to deliver successful trial outcomes Ability to operate effectively in cross-functional, multi-disciplinary teams Understanding of FDA regulations and ICH GCP guidelines and how to apply them to drive effective, efficient, timely strategies Benefits & Compensation
Lyell offers a comprehensive compensation and benefits package. The salary range for this position is $128,000 to $160,000 annually, with the opportunity to earn an annual bonus. Employees are eligible to participate in Lyell’s Equity Incentive Plan. Benefits include subsidized medical, dental and vision plans, FSA, Life and AD&D insurance, STD/LTD, ESPP, 401(k) with company match, transit benefits, cell phone reimbursement, and other elective benefits. Paid time off includes 18 days vacation, 9 days sick leave, 8 holidays plus a floating holiday, with summer and winter office shutdowns. Equal Opportunity
Lyell is 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, disability, medical condition, marital status, veteran status or any other characteristics protected by applicable laws. We’re excited about the potential fit; if you’re interested, please apply.
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Senior Clinical Trial Management Associate 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. Lyell is advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. The company’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness to drive durable tumor cytotoxicity and long-lasting clinical response. We were founded by cell therapy pioneers and 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 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 guidance from the Director/Associate Director Clinical Operations/Senior Clinical Trial Manager. Responsibilities
Completes trial related tasks with a high degree of autonomy Able to step into leadership scope including running Study Management meetings and managing vendor partnerships Develops tactical plans, detailed process steps and creates materials in addition to recommending strategic inputs and addressing problems with solutions Responsible for oversight of trial related tasks May take on CRO/vendor management for the defined trial and/or more complex trial program activities, ensuring deliverables are conducted on a timely, quality basis; identifies issues and makes recommendations to mitigate issues Tracks inputs and deliverables day-to-day in partnership with the Clinical Operations team; identifies ways to improve study progress, cross-functional follow up and pull through Collaborates effectively; mentors and serves as a subject matter expert for more junior clinical team members Supports TMF maintenance through timely filing of study and vendor documents, 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, monitors vendor invoices, and adheres to budget targets for assigned vendors Qualifications
BS in Life Sciences or related discipline, with a minimum of 5 years’ experience; or related discipline Experience in Oncology clinical trial programs required 3+ years of experience supporting clinical studies; early phase and start-ups a plus Track record of collaborating with and managing CROs and external vendors to deliver successful trial outcomes Ability to operate effectively in cross-functional, multi-disciplinary teams Understanding of FDA regulations and ICH GCP guidelines and how to apply them to drive effective, efficient, timely strategies Benefits & Compensation
Lyell offers a comprehensive compensation and benefits package. The salary range for this position is $128,000 to $160,000 annually, with the opportunity to earn an annual bonus. Employees are eligible to participate in Lyell’s Equity Incentive Plan. Benefits include subsidized medical, dental and vision plans, FSA, Life and AD&D insurance, STD/LTD, ESPP, 401(k) with company match, transit benefits, cell phone reimbursement, and other elective benefits. Paid time off includes 18 days vacation, 9 days sick leave, 8 holidays plus a floating holiday, with summer and winter office shutdowns. Equal Opportunity
Lyell is 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, disability, medical condition, marital status, veteran status or any other characteristics protected by applicable laws. We’re excited about the potential fit; if you’re interested, please apply.
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