About this position
About Kriya
Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.
We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.
We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America’s Best Startup Employers of 2024,” and honored as one of BioSpace’s “2025 Best Places to Work.”
Who You Are
This individual leads one or more gene therapy development program teams and be responsible for advancement of target candidates from early discovery through BLA submission and approval. The Sr. Director, Regulatory Affairs is expected to be a content specialist, with a keen understanding of overall nonclinical and clinical drug development, pharmacology, kinetics, immunology, and regulatory strategies to advance targets through various stages of development.
How You Contribute
- Provide strategic leadership and act as the single point of accountability for the development of an asset (or portfolio of assets) from target identification, generation of proof-of-concept data, and candidate selection through IND, clinical development, BLA, and approval
- Coordinate program team goals and activities across scientific functions to support the development path, deliver an asset to defined program and regulatory milestones in accordance with agreed timelines and budgets, and support corporate goals
- Provide oversight on material needs to execute planned studies, budgets, timelines, and resource needs to deliver high-quality data needed to make critical corporate decisions and drive strategy
- Make clear, evidence-based decisions (go / no go / accelerate) for the program based on whether results fulfil the program strategy, identify clear inflection points, and identify alternative strategies and/or additional opportunities for the asset
- Effectively manage direct reports to enable achievement of both departmental and corporate goals
- Present program summaries and updates to internal and external stakeholders
- Support the development of a robust pipeline across multiple therapeutic areas
- Identify and engage the external scientific/medical community to generate insights promoting efficient and effective advancement of Kriya’s portfolio
What You Bring to the Team
Education & Experience
- Ph.D. or equivalent advanced degree in a relevant scientific field
- 10+ years of experience in pharmaceutical drug development, biomedical research, or other relevant field, with experience in gene therapy development preferred
Competencies
- Deep expertise in pharmaceutical development
- Highly organized with attention to detail
- Strong communication and interpersonal skills
- Proven track record in management
- 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
- Familiarity with GxP requirements
- Broad knowledge of cell/gene therapy development (e.g., manufacturing, nonclinical, clinical, regulatory)
- Knowledge of product development and life cycle management concepts and interdependencies within the overall development process
Working Conditions and Physical Demands
- Primarily desk-based, generally in an office or home office setting.
- Involves extended periods of sitting and computer use.
- Occasional travel
Discover True Collaborative Teamwork
We have an ambitious set of goals, but our confidence – and our inspiration – stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day. We’re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.
What We Offer
Medical, Dental and Vision ∙ 401(k) with Company Match ∙ Short and Long-term Disability Benefits ∙ Company Paid Holidays ∙ Flexible Time Off ∙ Cyber Safety protection ∙ EAP ∙ Life Insurance ∙ Equity ∙ and more!
Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
All job requirements in the job description provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.