The Role
The Director of Clinical Trials leads clinical operations, providing strategic direction, overseeing trial design, ensuring compliance, and mentoring staff. They drive collaboration with leadership, manage CRO strategies, and influence organizational goals in clinical development.
Summary Generated by Built In
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.”
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.”
Role Overview
The Director, Clinical Trials serves as a senior organizational leader and expert in clinical trial design, coordination, and execution across the company’s clinical development portfolio. This role drives the strategic direction of clinical operations at the program and enterprise level, integrating expertise across multiple disciplines to ensure the highest standards of quality, compliance, and efficiency. The Director shapes organizational objectives and serves as a recognized internal and external thought leader, influencing clinical operations strategy and capability across the organization.
Key Responsibilities
Key Responsibilities
- Provide executive-level strategic direction and oversight for clinical operations across multiple development programs and therapeutic areas.
- Serve as a principal advisor and subject matter expert on all aspects of clinical trial design, execution, compliance, cost, and quality.
- Define and lead the organizational vision for clinical trial management practices, including SOP development and optimizations, vendor strategies, and operational standards.
- Partner with senior leadership across Clinical, Regulatory, Medical Affairs, and other functions to align clinical operations strategy with company objectives.
- Lead the design and evaluation of clinical development programs, applying advanced knowledge of statistical principles and clinical data standards.
- Drive enterprise-level CRO strategy, including selection, governance frameworks, and performance management systems.
- Oversee portfolio-level site management, monitoring strategies, and investigator network development.
- Provide expert guidance on clinical trial registration, disclosure strategy, and regulatory filing contributions.
- Establish and maintain senior KOL and institutional relationships to support program success.
- Lead portfolio-level risk identification, escalation, and mitigation strategy.
- Drive the design and implementation of company-wide clinical operational excellence initiatives.
- Lead, develop, and mentor clinical operations leadership and staff; shape functional organizational structure and culture.
- Serve as a spokesperson for clinical operations in external settings including regulatory interactions, industry forums, and partnership discussions.
- Perform other duties as required to support company goals and clinical program success.
Experience & Skills and Work Environment
Experience & Skills
- Bachelor’s degree required; advanced degree (MS, PhD, PharmD) highly preferred.
- 12+ years of progressive experience in clinical research in pharma/biotech, with demonstrated leadership across multiple programs and therapeutic areas.
- Prior experience serving as a key leader supporting organizational decision-making and strategic planning required.
- Experience with regulatory filings (NDA, BLA, MAA) and regulatory authority inspections required.
- Expert understanding of drug development from pre-IND through regulatory filing and commercialization.
- Demonstrated ability to lead enterprise-level initiatives and influence at the executive level.
- Experience designing and implementing monitoring and operational standards for global programs required.
- Experience in gene therapy, rare/orphan disease, or multiple specialized therapeutic areas highly desirable.
- Willing and able to travel domestically and internationally.
- Proficiency in Microsoft Office suite and clinical systems.
Work Environment
- Primarily desk-based, generally in an office or home office setting.
- Involves extended periods of sitting and computer use.
- Occasional travel may be required.
- Possibility of working outside of normal scheduled hours.
Life at Kriya
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.
Rewards & Benefits
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.
Rewards & Benefits
- Time Off & Work-Life Balance: Flexible Time Off ∙ Paid Parental & Medical Leave ∙ Paid Company Holidays
- Health & Wellness: Fertility & Family Building Benefits ∙ Medical, Dental, and Vision Insurance ∙ Employee Assistance Program (EAP) ∙ Life Insurance ∙ Short- and Long-Term Disability Coverage
- Financial Security: Equity ∙ 401(k) with Company Match ∙ Identity Theft Protection
- And More!
About
won't let me leave this section blank
Skills Required
- Bachelor's degree required; advanced degree (MS, PhD, PharmD) highly preferred
- 12+ years of progressive experience in clinical research in pharma/biotech
- Prior experience serving as a key leader supporting organizational decision-making and strategic planning
- Experience with regulatory filings (NDA, BLA, MAA)
- Expert understanding of drug development from pre-IND through regulatory filing and commercialization
- Experience designing and implementing monitoring and operational standards for global programs
- Experience in gene therapy, rare/orphan disease, or multiple specialized therapeutic areas
- Willing and able to travel domestically and internationally
- Proficiency in Microsoft Office suite and clinical systems
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
Kriya Therapeutics is a biopharmaceutical company dedicated to developing and manufacturing transformative, one-time gene therapies to address chronic diseases affecting millions of people worldwide. With operations in Research Triangle Park, North Carolina, and Silicon Valley, California, Kriya leverages an innovative platform for research, development, and manufacturing to revolutionize medicine and eliminate the burden of disease, aiming to make life-changing therapies accessible to all in need.
