Director, Immunology Lab

SUMMARY:

This position will lead a research group focused on investigative Immunology and the development and method transfer and/or in house implementation of Immunological assays that support Kriya’s current and exploratory programs. This role will serve as a key scientific leader within the company by guiding the collection of key Immunology data enabling candidate selections and advancement of assets into clinical development. As the lab leader, this person will work closely with cross functional departments including Nonclinical, Bioanalytical, Early Development, and Analytical to evaluate the need for, design, and implement Immunologic and pharmacodynamic assays. Investigative Immunology work utilizing novel models and assays designed to evaluate Immunogenicity and potential reduction thereof will also be a focus. This individual will guide and develop laboratory scientists to uphold a level of excellence and scientific rigor that enable strong decision making for Kriya to build a world class pipeline of assets that have the potential to transform patients’ lives with our therapies.

RESPONSIBILITIES:

• Support design and buildout of new Immunology laboratory and then initiation of work and any required optimization of laboratory functionality required over time.
• Lead a group of scientists who execute the nonclinical/laboratory activities to support achievement of annual corporate goals and objectives
• Manages and supervises portfolio of nonclinical programs across the pipeline encompassing research phase assets through later stage development assets.
• Responsible for delivering data in support of pharmacology and translational studies to support program stage gate decision making.
• Manages group who develops novel assays to implement for in house implementation for study sample analysis and or methods transfer to CROs and management thereof.
• With Immunology Director, develops and manages novel immunogenicity assays supporting vector immunogenicity assessment
• Communicates regularly with functional and program heads as well as prepares documents to support data sharing and decision making to both senior management as well as within the functional groups
• Assists in budget planning and tracking to ensure appropriate corporate projections for spend are met
• Builds a culture of collaboration and flexibility to support Kriya’s corporate mission and adherence to corporate values
• Ensures appropriate documentation of experimental design and rational and data outputs from experiments conducted to support regulatory filings and intellectual property generation
• Representing Immunology for due diligence exercises; reviewing all immunology documentation, identify issues/risks/gaps with development
• Providing Immunology expertise and consultancy contributing to regulatory submissions (BLAs, INDs, CTAs, IBs, etc.)

REQUIREMENTS:

• Ph.D. with a minimum of 5 years of industry experience evaluating immune pharmacology and/or safety parameters.
• Must be highly organized with attention to detail and proven ability to manage multiple projects/tasks at one time
• Must have strong communication and interpersonal skills
• Highly adaptable to change
• Positive attitude with a solutions-based approach to challenges with a dedication to delivering quality results
• Being an integrity role model by visibly and consistently speaking and acting with superior moral values
• Demonstrated excellence in study design and implementation of nonclinical immunology, immunotoxicology, and immunogenicity studies outsourced to CROs. Experience designing and implementing translational and Phase 0 Immunology studies desired
• Good working knowledge of, and skill in applying, applicable nonclinical and clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Individuals with experience developing/applying gene therapies, especially in the treatment of Ophthalmology, Oncology, and/or orphan diseases highly preferred

WORKING CONDITIONS:

Must be willing to travel up to 15% (once COVID situation resolves)

This is an exciting time to participate in the field of gene therapy in general, and to become a part of Kriya Therapeutics’ fast-growing dedicated team. We offer an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.