Director, Clinical Operations
Lyell Immunopharma
9 hours ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Role Responsibilities:
- Lead development of strategic planning for assigned clinical trial portfolio (timelines, budgets, internal/external resourcing).
- Oversee operational feasibility; make recommendations/decisions aligned with study and patient needs.
- Oversee study execution; manage risks across timeline, budget, and quality; advise mitigation actions.
- Ensure cross-functional alignment on tactics/plans; address issues to resolve concerns.
- Lead talent development (coaching and performance management); guide talent management and model leader behaviors.
- Support TMF maintenance via timely filing of study and vendor documents.
- Review TMF health, work with CTM on mitigation strategies, and escalate TMF needs (vendors/systems) as needed.
- Develop the department in collaboration with VP Clinical Operations to establish needed processes/procedures.
- Effectively manage budgets and resources to meet goals.
Preferred Education:
- BSc with 17+ years’ experience; or MSc with 14+ years’ experience.
Preferred Experience:
- 8+ years in oncology drug development and cell therapy.
- 3+ years in early-stage drug programs.
- Proven experience designing/developing clinical trial programs.
- Prior experience with BLA submissions and regulatory authority inspections (desirable).
Knowledge/Skills:
- Experience managing CROs/external vendors.
- Ability to lead clinical operations and cross-functional study execution teams.
- In-depth understanding of FDA regulations and ICH GCP; applied to studies for effective, efficient, timely strategies.
Compensation/Benefits:
- Salary: $200,000–$240,000 annually; annual bonus opportunity; eligibility for Equity Incentive Plan.
Application Instructions:
- If interested and you think you could fit, please apply.
- Lead development of strategic planning for assigned clinical trial portfolio (timelines, budgets, internal/external resourcing).
- Oversee operational feasibility; make recommendations/decisions aligned with study and patient needs.
- Oversee study execution; manage risks across timeline, budget, and quality; advise mitigation actions.
- Ensure cross-functional alignment on tactics/plans; address issues to resolve concerns.
- Lead talent development (coaching and performance management); guide talent management and model leader behaviors.
- Support TMF maintenance via timely filing of study and vendor documents.
- Review TMF health, work with CTM on mitigation strategies, and escalate TMF needs (vendors/systems) as needed.
- Develop the department in collaboration with VP Clinical Operations to establish needed processes/procedures.
- Effectively manage budgets and resources to meet goals.
Preferred Education:
- BSc with 17+ years’ experience; or MSc with 14+ years’ experience.
Preferred Experience:
- 8+ years in oncology drug development and cell therapy.
- 3+ years in early-stage drug programs.
- Proven experience designing/developing clinical trial programs.
- Prior experience with BLA submissions and regulatory authority inspections (desirable).
Knowledge/Skills:
- Experience managing CROs/external vendors.
- Ability to lead clinical operations and cross-functional study execution teams.
- In-depth understanding of FDA regulations and ICH GCP; applied to studies for effective, efficient, timely strategies.
Compensation/Benefits:
- Salary: $200,000–$240,000 annually; annual bonus opportunity; eligibility for Equity Incentive Plan.
Application Instructions:
- If interested and you think you could fit, please apply.