Associate Director Clinical Operations

Role Summary

Lead the execution of assigned large/global complex clinical trials and manage the Clinical Operations staff supporting the trial. Define and oversee trial plans, ensure alignment with strategy, and report study progress to stakeholders. Collaborate with cross-functional teams and CROs to drive timelines, budget, and quality. This is a hybrid role based in Seattle, WA or South San Francisco, CA.

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

Qualifications

• Required: Oncology drug development experience; cell therapy experience
• Preferred: Track record of successful delivery clinical trial timelines and budgets
• Preferred: 2+ years managing clinical trial programs for early-stage products
• Preferred: Track record of collaborating and managing CROs and other external vendors to deliver successful trial outcomes
• Preferred: Effectively leading cross-functional study management teams, may have some management of clinical operations teams
• Preferred: 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

Education

• BS in Life Science or related discipline; minimum 7 years of work experience