Sr Director, Clinical Data Management

Kriya Therapeutics Inc•Morrisville, NC

53d

About The Position

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. 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.

Requirements

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 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.

Nice To Haves

Experience in gene therapy, rare/orphan disease highly desirable
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

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