Sr. Director, Nonclinical Ophthalmology

Company Summary:

Kriya is a next generation gene therapy company focused on expanding the field to new frontiers. We have built a fully integrated, technology enabled platform for rational vector design, analytical characterization, and scalable manufacturing to design and develop gene therapies for diseases with well-understood underlying biology. We believe that rationally engineered gene therapies can transform the treatment of a broad universe of diseases – and we are prepared to lead this revolution in medicine.

Our team is made up of leading scientific experts who are passionate about improving patients’ lives and easing the burden of these life-changing disorders for patients. We are looking for teammates with the ambition, creativity, and energy to help us build a unique organization.

If you are looking to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, Kriya is the company for you.

Position Summary: 

The individual hired into this role will lead ophthalmology gene therapy development project teams from early discovery through IND submission.  The Sr. Director, Nonclinical Ophthalmology will coordinate and manage various research, proof-of-concept and formal nonclinical studies leading to filings of pre-IND packages, INDs and eventually BLAs for a broad array of projects. As a key member of various project teams, the Sr. Director, Nonclinical Ophthalmology is expected to be a content specialist, with a keen understanding of ophthalmology pharmacology/kinetics and regulatory strategy to advance ophthalmic therapeutic targets through various stages of development.  He/She will have broad knowledge of ocular pharmacology, disease biology, and animal models that support the evaluation of Kriya’s pipeline of gene therapies.  They will work closely across functions within the company to support the translational development of Kriya’s gene therapy candidates.  Additionally, this individual will support data analysis and presentation of preclinical/nonclinical studies with internal and external stakeholders.  

 Primary Responsibilities:

• Strategic leadership and single point of accountability for the nonclinical development of an asset or portfolio of assets within R&D, from candidate selection through IND 
• Representing Nonclinical on ophthalmology focused project teams; directing project related nonclinical efforts to support the development path, identifying alternate indications and provide supporting proof of concept, definitive pharmacology, and safety data
• Makes clear evidence-based go / no go / accelerate decisions, based on whether the results fulfil the strategy set out for the medicine, and identify clear inflection points
• Representing Pharmacology/Target Biology for due diligence exercises; reviewing all nonclinical and bioanalytical documentation, identify issues/risks/gaps to development
• Providing nonclinical and early development expertise and consultancy contributing to regulatory submissions (BLAs, INDs, CTAs, IBs, etc.)
• Identifies and engages the external community appropriately in robust scientific dialogue that generates insight and advances scientific understanding for how to advance Kriya’s portfolio
• Coordinate project team goals and activities with other areas (product design, analytical, assays, etc.) to ensure efficient, timely and harmonious achievement of program goals.
• Provide oversight on material needs to execute planned studies, budgets, timelines, and resource needs to execute and deliver high quality data needed to make critical corporate decisions and drive strategy

Required Qualifications:

• Ph.D. with 10 years of industry experience in research and development within academia or pharmaceutical/biotech industry
• Core/Deep expertise in ophthalmologic in vivo methods  including optical coherence tomography (OCT), fundus imaging and ocular electrophysiology
• Successful/track record of regulatory submissions (e.g., IND, IMPD)
• Highly organized with attention to detail
• Strong communication and interpersonal skills 
• Strong track record of driving excellence within an organization
• 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

• Proven ability to manage multiple projects/tasks at one time
• Strong prior experience in study design and drafting of nonclinical pharmacology and/or toxicology studies outsourced to CROs preferred
• Deep understanding of GLP requirements 

• Broad knowledge of applied pharmacology and its related disciplines (e.g. DMPK, toxicology) as it relates to cell/gene therapy development (e.g. Manufacturing, Clinical, Regulatory)
• Knowledge of product development and life cycle management concepts and interdependencies within the overall development process
• Level will commiserate with experience

Working Conditions:

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

We celebrate diversity and are committed to creating an inclusive environment for all employees.