Director, Clinical Operations

Key Role and Responsibilities

Leads the development of strategic planning for assigned clinical trial portfolio including timelines, budgets and resourcing (internal and external)

Oversight of operational feasibility; making decisions on recommendations and solutions to align with study and patient needs

Oversees study execution; manages risks in timeline, budget and quality, advises the team on actions to mitigate these risks

Ensures the cross-functional team is aligned with tactics and plans; addresses issues directly to resolve concerns

Leads the development of talent; ensures coaching and performance management is conducted in a timely

Guides leaders in talent management. Models the Lyell Leader Behaviors.

Supports TMF maintenance activities through timely filing of study and vendor documents as needed.

Oversees TMF quality by reviewing TMF health and works with CTM to develop mitigation strategies to ensure TMF issues are

Escalates any TMF-related needs (vendors, systems) to senior leadership as needed, to support TMF health.

Develops the department; collaborates with VP Clinical Operations to ensure processes and procedures are in place as needed for the maturity of the department

Effectively manages budgets and resources to meet goals and objectives

PREFERRED EDUCATION

BSc with a minimum of 17 years' experience

PREFERRED EXPERIENCE

A minimum of 8 years' experience in Oncology drug development and cell therapy experience

A minimum of 3 years' experience in early-stage drug programs

Proven experience in the design and development of clinical trial program

Prior experience with BLA submissions and regulatory authority inspections desirable