Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. At Lyell, our goal is to change that. We are a clinical-stage T-cell reprogramming company advancing a diverse pipeline of cell therapies for solid tumors based on our innovative technologies. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to defeat solid tumors, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency.
POSITION SUMMARY
The individual in this role will be responsible for leading the organization’s pathology core and be part of a larger interdisciplinary team supporting CAR-T research and translational projects. This role will provide scientific leadership, people management, and strategic direction for delivering pathology services, as well as collaborate closely with research groups and the In vivo pharmacology core. The incumbent will be a key member of our non-clinical safety leadership team, providing a comprehensive view of translational safety and pathophysiology to advance candidates through our pipeline.
KEY ROLE AND RESPONSIBILITIES
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Provide pathology support and oversee clinical pharmacodynamic biomarker assay development (patient biopsy sample assay for in situ characterization of therapeutic T cells and patient tumors to assess the effect of Lyell’s T cells products in the clinical trials)
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Support multiple discovery stage research programs and early clinical development plans by designing and reporting appropriate studies for pathology analysis, tissue-based assay development, target expression profiling, tumor type selection/validation, and nonclinical safety (toxicity) assessment.
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Provide pathology support for in vivo studies to assess the effect of novel T cells, platforms, and technologies and analysis of unexpected safety events in all nonclinical studies.
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Effectively prioritize and manage study timelines and resource allocations with a deeper understanding of Lyell’s research projects and proprietary technologies.
- Responsible for ensuring high-quality analysis, interpretation, and presentation of pathology data in research project team meetings.
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Ensure timely and accurate collection of pathology study data in various databases and ELN and generate high-quality reports for external publications and regulatory filings.
- Collaborate with facilities to maintain a well-functioning pathology lab that anticipates the needs of its users and our research organization.
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Actively serve as a member of the Research leadership team and other leadership/cross-functional/managerial activities.
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Successfully manage, mentor, and ensure career development of pathology team members.
PREFERRED EDUCATION & EXPERIENCE:
- DVM, PhD with a minimum of 10 years post-graduate experience
- Board certifications in anatomic pathology
- DABT certification
- 10+ years of hands-on pathology experience in an academic or industrial setting, along with significant prior supervisory experience managing multiple reports
- Knowledge and experience with LIMS/ELN/HALO Link software and familiarity with the whole slide-scanning platform
- Proven experience with multiple successful regulatory filings (e.g., IND/CTA, NDA/BLA) as a subject matter expert for pathology/toxicology, in vivo pharmacology, and nonclinical sections.
- In-depth knowledge and understanding of comparative anatomy and pathology (e.g., human, non-human primate, rodents) and its application in general oncology, immunology, and toxicology
- Ability to identify physiological and pathological changes in any tissue/cell types in multiple species and ability to accurately assess toxicologically vs. pharmacologically related events, test vs. test system-related events
- Up-to-date knowledge of common and emerging tissue-based pathology, toxicology, and biomarker research platforms, including multiplex immunofluorescence.
- Ability to adopt digital pathology for highly quantitative data-rich analysis.
- In-depth and up-to-date understanding of relevant regulatory and GxP requirements.
- Nonclinical safety assessment (toxicology) support for development programs (designing, advising, reviewing the study plans, and integrating toxicology assessment of Lyell’s development candidates)
- Strong understanding of immunology, T-cell biology, and immunotoxicology. Strong ability to investigate nonclinical safety-related (adverse) events in nonclinical/clinical study settings
- Strong collaboration, project management, data analysis, and scientific presentation skills
- Proficiency in using office software such as Microsoft Word® PowerPoint® or equivalents to generate reports and presentations.
- Strong verbal and written communication skills and capable of routinely interpreting data and presenting to diverse groups within Research and Development.
Lyell offers its employees a range of compensation and benefits. To assist you with your decision to apply for this role, the following decision to apply for this role, the following information and links to our site highlight our competitive market position and support to our employees and their dependents.
The salary range for this position is $195,000 to $220,000 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.
Our Employee Benefits program is extensive and includes subsidized medical, dental, and vision plans from your first day of employment, FSA, Company provided Life and AD&D Insurance as well as STD and LTD Insurance, ESPP, a 401(k) Plan with Company match, mass transit commuter benefits, cell phone reimbursement and a range of supplemental benefits that you may choose to elect. Our paid time-off benefits currently include 18 days’ vacation, 9 days’ sick leave, 8 observed holidays, as well as a floating holiday. We also have a summer and a winter office shutdown. More information on our extensive benefits offering can be found here.
At Lyell, we believe that the highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse, and inclusive culture for all employees. Lyell is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, citizenship status, national origin, ancestry, sex, sexual orientation, age, religion, creed, physical or mental disability, medical condition, marital status, veteran status or any other characteristics protected under applicable federal, state and local laws.
We’ve learned from experience that some of the best people don’t always match our requirements perfectly - if you’re interested and think you could fit, please don’t hesitate to apply.
