Associate Director, Clinical Operations at Lyell Immunopharma

South San Francisco, California, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Jan, 26

Salary

210000.0

Posted On

08 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Operations, Trial Management, Oncology Drug Development, Cell Therapy, CRO Management, FDA Regulations, ICH GCP Guidelines, Budget Management, Team Leadership, Talent Development, Study Strategy, Operational Feasibility, TMF Maintenance, Cross-Functional Collaboration, Problem Solving, Coaching

Industry

Biotechnology Research

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. This is a hybrid role and can be based out of our Seattle, Washington office OR our South San Francisco, California office. POSITION SUMMARY: The individual in this role will be accountable for leading the execution of assigned large/global complex Clinical Trial and manages the Clinical Operations staff assigned to the trial. KEY ROLE AND RESPONSIBILITIES: Defines and oversees trial plans that align with the defined strategy; sets plans and is accountable for day-to-day management actions and reporting of study progress to stakeholders Contributes to defining study strategy, interprets and implements the defined strategy; identifies operational feasibility issues and proposes solutions to address these concerns. Executes large/complex trials; primary point of contact for the CRO, leads the Study Management Team (SMT), but may delegate SMT responsibilities to more junior CTMs. May have some oversight of study execution for large, global studies and oversees regional CTMs who support study execution. Ensures the cross-functional team is aligned with tactics and plans; addresses issues and troubleshoots to ensure timelines and patient needs are achieved, escalates to the Director/Sr Director as needed for support Manages talent and develops capability for direct reports; models the Lyell Behaviors and provides timely and consistent feedback and coaching, manages performance and supports career progression for staff Supports TMF maintenance activities through timely filing of study and vendor documents. Trains study functional leads on roles and responsibilities related to TMF maintenance. Oversees TMF quality by assessing TMF related metrics and develops mitigation strategies to ensure TMF issues are addressed. Develops and recommends processes and procedures that support effective trial management suitable for the stage of the product/program Monitors and adheres to budget targets for their study PREFERRED EDUCATION & EXPERIENCE: BS in Life Science or related discipline with a minimum of 7 years of work experience Track record of successful delivery clinical trial timelines and budgets 2+ years managing clinical trial programs for early-stage products Oncology drug development experience required; plus, to have cell therapy experience Track record of collaborating and managing CROs and other external vendors to deliver successful trial outcomes Effectively leading cross-functional study management teams, may have some management of clinical operations teams Has in depth understanding of FDA regulations and ICH GCP guidelines; successfully applied these to studies and programs, 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 $175,000 to $210,000, 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.

Responsibilities

The individual will lead the execution of large/global complex clinical trials and manage the Clinical Operations staff assigned to the trial. They will ensure alignment of the cross-functional team with tactics and plans, addressing issues to meet timelines and patient needs.