Director, Clinical Trials

Kriya Therapeutics•Morrisville, NC

1d•Hybrid

About The Position

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.

Requirements

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.
Proficiency in Microsoft Office suite and clinical systems.

Nice To Haves

Experience in gene therapy, rare/orphan disease, or multiple specialized therapeutic areas highly desirable.

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.