Senior Director, Clinical Trial Liaison

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

The Senior Director, Clinical Research Liaison is responsible for sponsor oversight of outsourcing and delivery of the site management and data monitoring function across the clinical development programs. This role will work collaboratively and strategically with cross-functional teams and external partners to ensure that all data monitoring activities are conducted to the highest Good Clinical Practice (GCP) and quality standards, in accordance with established contractual agreements and budgets. 

How You Contribute

• Accountable to oversee and manage clinical site management & monitoring oversight for outsourced clinical trials and global development programs in accordance with industry clinical data standards
• Assists in the identification, hiring, training, and onboarding of appropriate clinical monitoring liaison/oversight function resources to support multiple development programs in accordance with plans, strategies, data deliverables, budgets, and timelines
• Accountable to lead and manage team of oversight liaisons to provide study teams with high-level insight into site-level issues and trends across programs; to assist in proactive development of protocol-specific risk-mitigation plans/strategies 
• Assist and contribute to clinical site management & monitoring/vendor identification during bid defense discussions
• In consultation with cross-functional partners and cross-functional leadership, assist in the development of clinical site management & monitoring related key performance indicators (KPIs) and key quality indicators (KQIs) to build into contractual agreements and create internal plans and processes 
• Establish and foster supportive sponsor/site/CRO relationships with the goal of enhanced quality and a proactive approach to risk-mitigation, resolution of issues, and for increased quality and compliance 
• Align internal initiatives and requirements with review and annotation of CRO clinical monitoring related documentation including clinical protocols, monitoring plans, oversight plans, safety plans, risk-based critical data identification, protocol deviation plans, etc.
• Accountable for oversight of feasibility and investigator/site identification/selection activities, including development of quality and performance standards to support data-driven decision-making, start-up activities, screening/recruitment projections, and recruitment/retention management, as well as ensuring ongoing site management/monitoring and follow-up activities throughout the startup process
• Accountable to oversee and/or manage performance of external vendors (at the site level) and establish communication pathways with relevant cross-functional partners for appropriate remediation and corrective action 
• Responsible for clinical monitoring deliverables (e.g., monitoring resource identification/selection, on-site/remote monitoring, centralized monitoring, data collection, entry, cleaning, investigator/site compliance and issue management etc.); to ensure quality completion of all clinical monitoring related deliverables and planned milestones
• Lead portfolio-level clinical site management & monitoring oversight related risk identification, management, and mitigation efforts and report progress to senior leadership per appropriate escalation pathways
• In partnership with Medical Affairs, if/when applicable, assist in the creation and planning/administration of training and reinforcement of key messages around the operational aspects of the study/administration of the investigational product, and assist in the development of site-specific operational strategies 
• Hiring, managing, and resourcing of oversight liaison staff (internal and externally outsourced) 
• Make recommendations and contributions to Quality Assuran