Director, Clinical Science
$220,000–$260,000 year
On-siteSeattle, Washington, United States
Job Summary
Conduct study medical monitoring for pivotal PiNACLE and PiNACLE-H2H trials, partnering with monitors to oversee data review, protocol adherence, and adverse event reporting. Collaborate on clinical trial design, endpoint selection, and regulatory submissions including IND and BLA documents. Coordinate cross-functionally with operations, biostatistics, and external stakeholders to manage site visits, steering committees, and data cleaning for publications. Identify innovation opportunities in trial methodologies and monitor risks to ensure scientific integrity. This hands-on role supports Lyell's next-generation CAR T-cell therapies for solid tumors and hematologic malignancies, reporting to the VP of Clinical Development.
Required Qualifications
- 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
- 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
Desired Qualifications
- 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)
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