Director/Senior Director Translational Science
Position Summary: Reporting to the Chief Technology Officer, the Director/Senior Director of Clinical and Translational Science is responsible for leading Artiva’s development and clinical application of product-related assays. Artiva is a start-up US-based biotechnology company developing a pipeline of novel allogeneic NK-cell therapy oncology products for application with monoclonal antibodies and/or engineered for specific tumor targeting. This position will responsible for the design, development and optimization of pharmacokinetic and pharmacodynamic analytical assays for implementation during clinical development. Assays will be developed via contract research organization (CRO) or in collaboration with our research partners. The successful candidate will have strong cell therapeutic development history with demonstrated leadership in immunological assay development and more specifically NK and/or T-cell immuno-oncology. A thorough understanding and application of flow cytometry and molecular/genomic techniques for studying immunological activity and therapeutic cell biodistribution and kinetics is a prerequisite for this position.
Role & Responsibilities
- Lead the development of highly sensitive and specific assays for the detection and tracking of human allogeneic NK-cells for the study of: Therapeutic cell persistence;Patient-donor chimerism;Tumor infiltration
- Lead the definition and development of immune activity assays for assessment of pharmacodynamic response to cell therapies, including immune cell activation and cytokine upregulation
- Select, contract and manage CRO-driven programs for assay development, optimization and clinical sample analytics.
- Collaborate with research and clinical staff and clinical-site partners for patient sample acquisition and testing procedures.
- Draft, optimize and implement SOPs supporting product and clinical sample analytics
- Draft relevant sections of CTDs to support IND filing, updates and maintenance
- Potential future responsibility for group-building and staff management
- Develop transparent relationships across the organization including GCLabCell and other partners and/or collaborators.
Experience, Education and Specialized Knowledge and Skills
- Ph.D. in immunology, biology, biochemistry or related discipline
- A minimum of 5 years’ direct experience leading the development of immunological, pharmacodynamic and pharmacokinetic assays for cell therapeutics within the biotechnology industry or hematopoietic transplant setting is a requirement.
- Demonstrated expert knowledge of cell therapeutics, particularly T-cells and Natural Killer cells
- Proven ability to manage CRO-driven research and development programs and operate without internal company laboratories
- Demonstrated experience in SOP development and regulatory document drafting
- Excellent communication skills, verbal and written.
- Ability to interact effectively across boundaries using influencing and relationship building skills.
- Strong problem solving capabilities with the ability to prioritize and make tradeoffs to achieve goals.
- Strong understanding of the drug development and regulatory process.