At Lyell, our vision is to develop curative cell-based immunotherapies for solid tumor cancers. We have innovative science originating from our founder's world class labs and a unique and disruptive approach to research and development. Our company is first and foremost focused on understanding the science. We are a learning organization, dependent on deep collaborative relationships between all of our colleagues, partners and founders. Our culture is based on Science, Respect, Courage and Collaboration and it reflects who we are and the environment we are creating.
Lyell is seeking a knowledgeable, skilled and accomplished technical specialist to implement biomarker assays and drive the success of our clinical biomarker strategy. The successful candidate will have technical expertise in flow cytometry and / or sequencing-based biomarker assay platforms. This will be combined with experience in successfully leading contract research organizations (CROs) selection and management, assay development and validation projects and clinical biomarker operations. The assay technologies to be implemented include high dimensional flow cytometry, next generation DNA / RNA sequencing and qPCR-based PK analysis. The specialist will leverage a combination of technical knowledge, understanding of GCLP regulatory requirements and project management skills. They will work collaboratively with Lyell non-clinical research, clinical development and CROs to insure the successful generation of high impact clinical biomarker datasets, maximizing the scientific value of our innovative cell therapy trials. This is a high visibility, high impact role in our Translational Science group, with opportunities for growth in the technical, scientific and leadership aspects of professional development.
- Engagement, evaluation and selection of biomarker CROs; management of CROs at all phases of biomarker plan implementation from CRO selection through clinical sample analysis and data delivery
- Critical evaluation of biomarker assay protocols, validation data, regulatory compliance and clinical sample analysis lab environments
- Development, trouble-shooting and optimization of biomarker sample collection, processing and shipment methods including lab kit development
- Collaboration with Lyell clinical operations and CROs to design and execute sample and data management plans; follow-up with clinical sites, study teams and CROs to resolve biomarker-related issues or queries
- Insure CRO deliverables meet regulatory and quality requirements as well as study timelines
- Serve as subject matter expert in clinical assay validation and trial implementation with specialization in flow cytometry and/or sequencing-based biomarker platforms
- Authoring and critical review of validation reports, SOPs, clinical lab manual sections and related materials for documentation, implementation and communication of clinical biomarker assay protocols
- Evaluate new technologies, methods and platforms to enhance the quantity, quality and impact of clinical biomarker data
- Maintain high level of technical and scientific expertise leveraging scientific literature, conferences, internal meetings and training opportunities
- Breadth and depth of experience in clinical biomarker assay validation and implementation in immune-oncology and/or cell therapy early clinical development
- Strong expertise in either regulated clinical flow cytometry or sequencing-based assay design, development and validation; experience with both is a plus
- Experience working closely with a CRO to validate biomarker assays at the GCLP and/or CAP/CLIA level
- Application of GLP/GCLP regulatory guidance and industry white papers relevant to clinical biomarker assay validation and implementation
- Expertise in the use of relevant data analysis software (FloJo, Prism, Excel, Spotfire etc.)
- BSc in immunology, cell biology or related field with a minimum of 11 years' experience within the area of focus OR
- MSc in immunology, cell biology or related field with a minimum of 9 years' experience within the area of focus
- Ability to work independently as well as on interdisciplinary teams to achieve translational science objectives
- Written and oral communications skills to function efficiently and effectively in a highly collaborative environment including both internal and external stakeholders
- Ability to take initiative, leverage multiple sources of knowledge and expertise to make decisions and meet complex technical and operational challenges
- Ability to work efficiently, prioritize workflow, meet deadlines, balance competing priorities and adapt to change
At Lyell, we believe that 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.