We are seeking a highly skilled and experienced Senior Director, Data Management, to lead enterprise efforts to improve the quality, consistency, and governance of data across systems and the end-to-end data continuum. This strategic leader will define and drive the data management and standards strategy for Bluerock, establish company-wise data standards, processes, and enabling technologies, and collaborate closely with internal and external partners—including business, IT, and clinical data strategy/operations leaders—to ensure data is captured, structured, integrated, and leveraged effectively for operational excellence, product and platform development, and analytics.
This role will guide cross-functional teams in architecting and implementing data management capability and governance solutions, oversee standards governance and lifecycle management (including assessment of enhancements and deviations), and build strong partnerships with other stakeholders as well as Bayer and other key vendors to deliver high-quality, interoperable data. The Senior Director will also represent the organization in relevant industry standards forums and serve as a key resource in responding to data/standards questions from regulatory agencies.
Responsibilities:
- Lead company-wise data management strategy and operating model, positioning data as a strategic asset and enabling high-quality, trusted, and usable data across the end-to-end data continuum.
- Build data management capability, including governance, data quality, metadata/lineage, stewardship, and standards adoption.
- Partner with internal and external collaborators (business, IT, analytics/product teams, clinical operations/strategy, and vendors) to align priorities and deliver interoperable data solutions.
- Translate strategy into actionable roadmaps with milestones, KPIs, and clear ownership; monitor performance and service levels to ensure timely, high-quality delivery.
- Lead, mentor, develop high-performing teams and build strong relationships with business partner/vendors; conduct vendor qualifications and manage partner performance to meet quality and timeline expectations.
- Oversee standards governance and lifecycle management, including evaluation of enhancements, managing deviations, and driving continuous improvement through automation and process optimization.
- Ensure compliance with applicable regulatory expectations and internal SOPs; support inspection readiness and respond to regulator questions related to data and standards.
- Represent the organization in relevant industry standards forums and professional groups; communicate evolving guidance, standards, and best practices to internal stakeholders.
Minimum Requirements:
- Bachelor’s degree (or equivalent) in a scientific or healthcare-related discipline.
- 15+ years of clinical data management experience in pharma/biotech, including 5+ years in people leadership/management.
- Demonstrated ability to lead, coach, and develop teams.
- Strong analytical and problem-solving skills, with a proactive approach to identifying and resolving issues.
- Experience overseeing multiple vendors (e.g., CROs, ePRO, and EDC providers).
- Deep knowledge of data management processes and systems, including CDISC standards.
- Solid understanding of ICH, GCP, and global regulatory expectations related to data.
- Excellent organization, time management, and communication capabilities.
- Highly motivated and delivery-focused, with the ability to manage multiple priorities and projects.
- Strong collaboration, interpersonal, conflict-resolution, and problem-solving skills; late-phase trial and submission experience is preferred.
Top Skills
What We Do
BlueRock Therapeutics is a leading engineered cell therapy company with a mission to develop regenerative medicines for intractable diseases. BlueRock Therapeutics’ cell+gene platform harnesses the power of cells to create new medicines for neurology, cardiology, and immunology indications. BlueRock Therapeutics’ cell differentiation technology recapitulates the cell’s developmental biology to produce authentic cell therapies, which are further engineered for additional function. Utilizing these cell therapies to replace damaged or degenerated tissue brings the potential to restore or regenerate lost function. BlueRock’s culture is defined by scientific innovation, the highest ethical standards and an urgency to bring transformative treatments to all who would benefit. The company strives to be a top employer of scientific talent, empowering every member of the team to make meaningful and lasting contributions to the burgeoning field of regenerative medicine. Become a BlueRocker! We are expanding our BlueRock team at all locations. Contact us via LinkedIn or our website to learn about rewarding career opportunities.
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