Associate Director, Clinical Operations at Lyell Immunopharma

Seattle, Washington, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, OncologyIndustries

Requirements

BS in Life Science or related discipline with a minimum of 7 years of work experience
Track record of successful delivery of clinical trial timelines and budgets
2+ years managing clinical trial programs for early-stage products
Oncology drug development experience required; cell therapy experience preferred
Track record of collaborating and managing CROs and other external vendors to deliver successful trial outcomes
Effectively leading cross-functional study management

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

Skills

Clinical Trial Management

Clinical Operations

Global Clinical Trials

Trial Planning

Staff Management

CAR T-cell Therapy

Cell Therapy

T-cell Biology

Lyell Immunopharma

Develops advanced cell therapies for cancer

About Lyell Immunopharma

Lyell Immunopharma develops advanced cell therapies aimed at treating solid tumors, which are cancerous tissue masses. The company focuses on enhancing T cells, a type of immune cell, to effectively target and eliminate cancer cells. Their approach includes genetic and epigenetic reprogramming of T cells to address challenges like T cell exhaustion and to ensure T cells can persist in the body. Unlike many competitors, Lyell is dedicated to creating curative treatments specifically for solid tumors, utilizing a diverse product pipeline that explores various treatment methods. The goal is to push the limits of current cancer therapies and provide effective solutions where traditional treatments have not succeeded.

San Francisco, CaliforniaHeadquarters

2018Year Founded

$479.6MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Commuter Benefits

Phone/Internet Stipend

Risks

Increased competition in T-cell therapies may impact Lyell's market share.

Delays in clinical data results could lead to investor uncertainty.

Integration challenges from ImmPACT Bio acquisition may divert focus from core operations.

Differentiation

Lyell focuses on T cell reprogramming to treat solid tumors effectively.

Their proprietary Gen-R and Epi-R platforms address T cell exhaustion and stemness.

Lyell's diverse product pipeline explores multiple treatment modalities for solid tumors.

Upsides

Acquisition of ImmPACT Bio enhances Lyell's CAR T-cell therapy capabilities.

Strategic partnership with MaxCyte boosts cell engineering and therapeutic development.

New leadership appointments strengthen Lyell's strategic direction and management.

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