Director, Clinical Science
Lyell Immunopharma
August 15, 2026
On-site
South San Francisco, CA
Clinical Research and Development
Director, Clinical Science (hands-on, collaborative)
The Director, Clinical Science supports design, execution, and oversight of clinical trials for Lyell’s cell therapies, ensuring adherence to regulatory standards, Good Clinical Practice (GCP), and scientific rigor (initially PiNACLE and PiNACLE-H2H).
Responsibilities:
- Partner with medical monitor(s) for study oversight, data review, and interpretation across assigned programs (initially PiNACLE and PiNACLE-H2H).
- Support medical monitor execution of clinical trials; ensure protocol, regulatory, and GCP adherence.
- Support patient safety monitoring, including adverse event identification/support at sites and timely regulatory reporting.
- Collaborate on design/development of clinical trial protocols; ensure scientific, medical, and regulatory alignment (endpoints, patient populations).
- Coordinate cross-functionally to ensure accurate/timely data collection, analysis, and reporting; interpret clinical/translational data for study decisions.
- Plan and coordinate data cleaning for analyses supporting publications (abstracts, presentations, manuscripts).
- Support preparation/review of regulatory documents (IND, BLA, clinical study reports, Investigator’s Brochures, and responses to agency inquiries).
- Collaborate across Clinical Operations, Translational Sciences, Biostatistics, Data Management, Pharmacovigilance, Regulatory Affairs, and Medical Affairs.
- Engage external stakeholders (sites/investigators, steering committees, S/ DSMCs, KOLs, CROs); support meetings, site visits, and SMC/DMC preparations.
- Identify innovation opportunities (including AI methods) and monitor risks with recommended timely actions.
Preferred Education:
- PhD, PharmD, PA-C, ARNP, MS, or BSRN in a related field; scientific/clinical education in immunology, oncology, molecular biology, or health care delivery.
Preferred Experience:
- 10+ years related experience in clinical/research/pharma.
- 4+ years in clinical development (7+ years related), ideally oncology with focus on cell therapy, T-cell engager, or immuno-oncology.
- Demonstrated experience supporting clinical trial design, execution, and oversight.
Skills/Abilities:
- Clinical trial design, regulatory submissions, data interpretation; familiarity with GCP/regulatory guidelines.
- Strong analytical, organizational, and communication skills; ability to manage multiple priorities in a fast-paced environment.
Compensation/Benefits:
- Salary range: $220,000–$260,000 annually; annual bonus opportunity; eligible for Lyell’s Equity Incentive Plan.
The Director, Clinical Science supports design, execution, and oversight of clinical trials for Lyell’s cell therapies, ensuring adherence to regulatory standards, Good Clinical Practice (GCP), and scientific rigor (initially PiNACLE and PiNACLE-H2H).
Responsibilities:
- Partner with medical monitor(s) for study oversight, data review, and interpretation across assigned programs (initially PiNACLE and PiNACLE-H2H).
- Support medical monitor execution of clinical trials; ensure protocol, regulatory, and GCP adherence.
- Support patient safety monitoring, including adverse event identification/support at sites and timely regulatory reporting.
- Collaborate on design/development of clinical trial protocols; ensure scientific, medical, and regulatory alignment (endpoints, patient populations).
- Coordinate cross-functionally to ensure accurate/timely data collection, analysis, and reporting; interpret clinical/translational data for study decisions.
- Plan and coordinate data cleaning for analyses supporting publications (abstracts, presentations, manuscripts).
- Support preparation/review of regulatory documents (IND, BLA, clinical study reports, Investigator’s Brochures, and responses to agency inquiries).
- Collaborate across Clinical Operations, Translational Sciences, Biostatistics, Data Management, Pharmacovigilance, Regulatory Affairs, and Medical Affairs.
- Engage external stakeholders (sites/investigators, steering committees, S/ DSMCs, KOLs, CROs); support meetings, site visits, and SMC/DMC preparations.
- Identify innovation opportunities (including AI methods) and monitor risks with recommended timely actions.
Preferred Education:
- PhD, PharmD, PA-C, ARNP, MS, or BSRN in a related field; scientific/clinical education in immunology, oncology, molecular biology, or health care delivery.
Preferred Experience:
- 10+ years related experience in clinical/research/pharma.
- 4+ years in clinical development (7+ years related), ideally oncology with focus on cell therapy, T-cell engager, or immuno-oncology.
- Demonstrated experience supporting clinical trial design, execution, and oversight.
Skills/Abilities:
- Clinical trial design, regulatory submissions, data interpretation; familiarity with GCP/regulatory guidelines.
- Strong analytical, organizational, and communication skills; ability to manage multiple priorities in a fast-paced environment.
Compensation/Benefits:
- Salary range: $220,000–$260,000 annually; annual bonus opportunity; eligible for Lyell’s Equity Incentive Plan.