Primary Responsibilities:
- Provide strategic leadership and oversight of Data Management activities across the clinical development portfolio.
- Lead and develop the Data Management function (organizational design, resource planning, budgeting, hiring, performance management).
- Establish and evolve a scalable Data Management operating model using internal capabilities and outsourced vendor/FSP partnerships.
- Oversee vendor selection, governance, contract management, and performance.
- Develop and implement Data Management standards, processes, SOPs, and inspection-readiness practices.
- Ensure timely delivery of high-quality clinical databases/datasets for analysis, regulatory submissions, and health authority inspections.
- Provide strategic oversight of clinical data management systems, technologies, and data standards.
- Identify operational risks and lead process improvement initiatives.
- Serve as Data Management subject matter expert during audits/inspections and cross-functional governance.
- Other responsibilities as assigned.
Education/Experience/Skills:
- Bachelorβs degree in scientific/biological/statistical/computer science field (advanced degree strongly preferred).
- Target ~15 years pharma/biotech experience; ~10 years direct report or vendor management.
- Experience managing multiple direct reports/contingent workers/programs; resource planning for Data Management deliverables.
- Self-directed technical leader with strategic, prospective approach to DM processes and customer management.
- Experience in both in-house and outsourced Data Management operating models.
- Vendor evaluation/selection/governance/management experience (CRO/FSP and others).
- Experience leading organizational change and process improvements within DM.
- Strong understanding of clinical trials, pharmaceutical operations, regulatory compliance, FDA regulations, and ICH data integrity.
- Ability to manage timelines, incomplete information, and unexpected events while maintaining accuracy.
- Strong influencing/communication across all organizational levels.
- Willingness to travel domestically and internationally as needed.