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Senior Clinical Trial Management Associate
Seattle, Washington, United States; South San Francisco, California, United States
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.
POSITION SUMMARY:
The individual in this role will be responsible for executing defined tasks in a trial with guidance from the Director/Associate Director/Sr CTM.
KEY ROLES AND RESPONSIBILITIES:
- Completes trial related tasks with a high degree of autonomy; able to step into leadership scope including running Study Management Team meetings and managing vendor partnerships (including central imaging and laboratory vendors that support cell therapy pivotal clinical trials)
- Develops tactical plans, detailed process steps and creates materials in addition to recommending strategic inputs and recommending ways to proactively address problems with solutions.
- Responsible for oversight of trial related tasks; including CRO/vendor management for the defined trial and more complex trial program activities, ensuring deliverables are conducted on a timely, quality basis. 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; 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 for vendors being managed. Monitors and adheres to budget targets for assigned vendors
PREFERRED EDUCATION & EXPERIENCE:
- BA/BSc in Life Science or related discipline
- Minimum 5 years experience in Oncology clinical trial programs required
- Proven support of clinical studies for 3+ 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
- Has understanding of FDA regulations and ICH GCP guidelines; learns how to successfully apply these to studies to drive effective, efficient and timely strategies
Lyell offers its employees a range of compensation and benefits. To assist you with your decision to apply for this role, the following decision to apply for this role, the following information and links to our site highlight our competitive market position and support to our employees and their dependents.
The salary range for this position is $128,000 to $160,000, 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.
Our Employee Benefits program is extensive and includes subsidized medical, dental and vision plans from your first day of employment, FSA, Company provided Life and AD&D Insurance as well as STD and LTD Insurance, ESPP, a 401(k) Plan with Company match, mass transit commuter benefits, cell phone reimbursement and a range of supplemental benefits that you may choose to elect. Our paid time-off benefits currently include 18 days’ vacation, 9 day’s sick leave, 8 observed holidays as well as a floating holiday. We also have a summer and a winter office shutdown.
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.
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