This role can be based out of either our Seattle, WA or South San Francisco, CA offices.
The Director, Clinical Science is a critical scientific partner in the clinical development of Lyell's potential cell therapies. Working in close partnership with medical monitors and cross-functional study teams, this role supports the design, execution, and oversight of clinical trials - ensuring adherence to regulatory standards, Good Clinical Practice (GCP), and scientific rigor. The role will focus initially on supporting study medical monitoring for the pivotal PiNACLE and PiNACLE-H2H studies, with the agility to support additional programs as the organization's needs evolve.
Reporting to the Vice President, Clinical Development, this is a hands-on, collaborative role centered on partnering, support, and cross-functional execution.
KEY ROLE AND RESPONSIBILITIESStudy Medical Monitoring - Partner with medical monitor(s) in study oversight, data review, and interpretation across assigned programs - initially the pivotal PiNACLE and PiNACLE-H2H studies, with agility to pivot and support other programs as organizational needs evolve.
- Support the medical monitor in execution of clinical trials, ensuring adherence to the protocol, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
- Contribute to patient safety monitoring by partnering with the medical monitor to identify and support site management of adverse events per protocol requirements, including required timely reporting to regulatory bodies.
Protocol Design & Clinical Trial Planning- Collaborate in the design and development of clinical trial protocols, ensuring they meet scientific, medical, and regulatory requirements, including selection of endpoints and patient populations.
- Assist in the planning and design of clinical trials, including the selection of endpoints and patient populations.
Data Review, Interpretation & Publications- Coordinate cross-functionally with the study team to ensure accurate and timely data collection, analysis, and reporting; assist with review and interpretation of clinical and translational data to make informed decisions about study execution.
- Plan and coordinate data cleaning activities to support the data analyses needed for planned publications (abstracts, presentations, and manuscripts).
Regulatory Submissions & Documentation- Support and contribute to the preparation and review of documents for regulatory submissions (IND, BLA, etc.), including clinical study reports, Investigator's Brochures, and responses to regulatory agency inquiries.
Cross-Functional & External Collaboration- Collaborate cross-functionally with key Lyell study and program teams - including (but not limited to) Clinical Operations, Translational Sciences, Biostatistics, Data Management, Pharmacovigilance, Regulatory Affairs, and Medical Affairs - to ensure seamless trial execution.
- Contribute to regularly planned and ad hoc interactions with external stakeholders and vendors, including study site investigators and staff, steering committees, Safety/Data Monitoring Committees, key opinion leaders (KOLs), and Contract Research Organizations (CROs), to collaboratively identify issues and solutions, facilitate trial operations and patient enrollment, and maintain high standards of scientific integrity.
- Participate in and support pan-study external meetings (e.g., regularly planned site study staff meetings and PI/Sub-I meetings), as well as site visits and meetings with PIs/Sub-Is/staff.
- Support preparations for, and participate as requested in, medical-scientific meetings/congresses, study steering committee meetings, and SMC/DMC preparations and meetings.
Innovation & Risk Management- Identify opportunities for innovation and improvement in clinical trial methodologies and therapeutic approaches, including use of Artificial Intelligence methods.
- Consistently monitor for risks and recommend actions to address issues in a timely manner.
PREFERRED EDUCATION- PhD, PharmD, PA-C, ARNP, MS, or BSRN in a related field.
- Scientific or clinical education in a relevant field (e.g., immunology, oncology, molecular biology, or health care delivery).
PREFERRED EXPERIENCE- 10+ years related experience delivering results in a clinical, research or pharmaceutical organization
- A minimum of 4 years' experience in clinical development, with 7+ years related experience, ideally in oncology, with a focus on cell therapy, T-cell engager, or immuno-oncology.
- Demonstrated experience supporting the design, execution, and oversight of clinical trials.
KNOWLEDGE, SKILLS, AND ABILITIES- Proficiency in clinical trial design, regulatory submissions, and data interpretation; familiarity with GCP and regulatory guidelines.
- Strong analytical, organizational, and communication skills; ability to work effectively in a collaborative, fast-paced environment.
- Ability to manage multiple priorities in a fast-paced, dynamic environment.
The salary range for this position is $220,000 to $260,000, annually, with the opportunity to earn an annual bonus. The salary range is an estimate, and the actual salary may vary based on Lyell's compensation practices and an applicant's qualifications and experience. Employees are also eligible to participate in Lyell's Equity Incentive Plan.
