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 Assurance audits and/or regulatory authority inspections; ensure adequate and timely follow-up/feedback, response, and completion is communicated to internal study teams
• Accountable for overall clinical monitoring performance of regulated clinical trials including inspection readiness; responsible for implementation of regular quality checks and results reporting to study teams
• Review and contribute to the development, review, and improvement of outsourced Standard Operating Procedures (SOPs), processes, systems, tools, and plans
  
  

What You Bring to the Team

Education & Experience

• Bachelor’s degree required, advanced degree highly desirable
• 12 years’ clinical research or equivalent healthcare experience with progressive management experience in clinical monitoring space (minimum 4 years of direct clinical monitoring oversight experience)
  
  

Competencies

• Experience in gene therapy, rare/orphan disease highly desirable
• Experience with designing, standardizing and implementing monitoring strategies and standards for global development programs is required
• Experience in the management/oversight of CROs performing monitoring activities is required; experience with establishing FSP is desired
• Experience with all aspects of clinical trial conduct (startup through close-out) is required
• Experience overseeing Investigator Initiated Trials/external sponsored research collaborations highly desirable
• Prior demonstrated experience serving as a key leader to support organizational decision making and strategic planning required
• Understanding of drug development and program management from pre-IND through regulatory filing
• Demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required.
• Experience in regulatory filings (e.g., NDA, BLA, MAA) highly desired
• Previous involvement in the oversight and management of GCP regulatory inspections desired
• Ability and willingness to travel, as needed, (domestic and international)
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  
  

Working Conditions

• Primarily desk-based, generally in an office or home office setting.
• Involves extended periods of sitting and computer use.
  
  

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.