Director of Immunology

Location
Redwood City, CA, United States
Posted
Mar 26, 2021
Ref
1849790762
Discipline
Science/R&D, Immunology
Hotbed
NextGen Bio
Required Education
Bachelors Degree
Position Type
Full time
SUMMARY:

The Director of Immunology will think creatively and critically to support the Kriya Immunology strategy from early research through clinical development. The individual hired into this role will support the immunological assessment of Kriya's gene therapy candidates under various stages of development. They will coordinate and manage various research, proof-of-concept, and IND enabling non-clinical and translational studies supporting pre-IND, INDs, and eventually BLA packages for a broad array of projects. As a key member of various project teams, the Director of Immunology is expected to be a content specialist in matters of Immunology and Immunogenicity with a keen understanding of their role in nonclinical and clinical development and associated regulatory strategy and requirements. Knowledge of cell/gene therapy development and life cycle management concepts and interdependencies with the overall development process preferred. The ideal individual for the role will be highly organized and adaptable with a passion for learning. They will work closely across functions within the company to support the translational development of Kriya's gene therapy candidates. This role will provide the individual the opportunity to grow and develop while advancing Kriya's pipeline of from research into clinical phase development.

PRIMARY RESPONSIBILITIES:

• Representing Immunology on project teams; directing project-related nonclinical and translational Immunology studies to support the development path, identifying alternate indications and provide supporting proof of concept data
• Support communications within the nonclinical, bioanalytical, clinical and regulatory functions, to ensure efficient communications between team members
• 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.)
• Responsible for identifying and liaising with CROs to define optimal in vitro and in vivo models that best support the translation to clinical development
• Presenting data in the form of poster and/or oral presentations at relevant scientific meetings; writing manuscripts for peer-reviewed literature based on study results
• Coordinate immunology goals and activities with other areas (product design, analytical, assays, etc.) to ensure efficient, timely and harmonious achievement of program goals.
• Supervise scientist and technicians as the company grows

REQUIREMENTS:

• Ph.D. with a minimum of 5 years of industry experience evaluating immune 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.

Apply at [email protected]