Sr Director, Clinical Data Management

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.”

Role Overview

The Senior Director, Clinical Data Management sets the vision, direction, and strategy for Data Management across our clinical development portfolio. This role will oversee the planning, execution and quality assurance of clinical data management activities across the clinical development programs, ensuring regulatory compliance and data integrity throughout the product development lifecycle. 

The ideal candidate has comprehensive expertise in data management of regulations and GCP requirements for drug development, advanced knowledge of Electronic Data Capture/related applications and industry standards, and advanced skills partnering with CROs and other third-party vendors. Additionally, he/she will possess advanced knowledge of clinical operations and relevant regulatory requirements. The individual will have advanced experience working on Phase I-IV studies within the biopharmaceutical industry across multiple therapeutic areas and is capable of leading DM activities to support regulatory submissions and inspections. Finally, this position has advanced skills in continuous improvement, project management, change management, and risk management.
 

Key Responsibilities

•  Develop and implement comprehensive clinical data management strategies aligned with company objectives and regulatory requirements
• Provides strong leadership and inspiration to the Data Management function. Forecasts and manages Data Management resources needs, budget and timelines. Hires, develops, and retains talents. Responsible for the performance management of the Data Management function, including performance of outsourced data management activities.
• Establish and maintain data management standards, processes, and best practices across all clinical programs 
• Collaborates within the function and cross-functionally to resolve issues pertaining to data management in clinical trials and submissions work.
•  Proactively identifies and manages risks for the data management function and supports functional risk identification/management efforts globally.
•  Serves as the internal Data Management expert to provide strategic thinking for outsourcing strategy. As a member of the CRO governance committee, provides strategic leadership in Data Management related topics and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.
•  Serves as a Data Management expert accountable for robust RD data management processes (including but not limited to CRF/eCRF design, all steps from database development to database release, data review and cleaning, database lock), to ensure data quality/integrity and regulatory compliance
•  Ensures that Data Management Plans are consistent and regulatory compliant across studies and programs.
•  Serves as the Data Management leader representing RD during regulatory inspections and internal audits pertaining to RD activities and ensures inspection readiness of all data management activities conducted internally or outsourced
   

Experience & Skills:

• Advanced degree (MS/PhD) in Life Sciences, Statistics, Computer Science, or related field, or BS with equivalent experience 
• Minimum 12 years of clinical data management experience in pharmaceutical/biotech industry 
• 6 years of leadership experience managing clinical data management teams
• Deep expertise with EDC systems (Medidata Rave preferred) and clinical data standards (CDISC/SDTM/ADaM) 
• Strong knowledge of GCP, 21 CFR Part 11, and global regulatory requirements
• Previous experience working with global clinical trials and diverse regulatory environments
• Experience in gene therapy, rare/orphan disease highly desirable 
• Experience with designing, standardizing and implementing data management 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
• 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., IND, CTA, NDA, BLA) highly desired
• Previous involvement in the oversight and management of GCP regulatory inspections desired
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor

Work Environment

• Primarily desk-based, generally in an office or home office setting
• May involve extended periods of sitting and computer use
• Ability to stand for extended hours 
• Ability to climb ladders/steps

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

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.