Director, Clinical Data Management

Role Overview

• Set the vision, direction, and strategy for Data Management (DM) across clinical development portfolio
• Oversee the planning, execution and quality assurance of clinical data management activities
• Collaborate within the function and cross-functionally to resolve data management issues
• Proactively identify and manage risks for the DM function
• Serve as internal DM expert for outsourcing strategy
• Ensure data quality/integrity and regulatory compliance for DM processes
• Drive SAP and programming timelines to meet deliverables
• Represent function in external professional initiatives to identify best practices

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, including 6+ years of leadership experience managing clinical data management teams and/or vendors
• Advanced knowledge and experience working on Global clinical trials (Phase I-IV) and diverse and relevant regulatory requirements within the biopharmaceutical industry across multiple therapeutic areas, including multiple myeloma, lymphoma, CAR-T Therapy
• 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
• Experience designing, standardizing and implementing data management strategies and standards for global development programs is required
• Experience in the management/oversight of CROs and other third-party vendors performing monitoring and DM activities is required
• 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, 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
• Advanced skills in continuous improvement, project management, change management, and risk management.

Tech Stack

• Google Cloud Platform

Benefits

• Flexible Time Off
• Health insurance
• Commuter benefits
• Free parking
• State-of-the-art gym
• Food hall