The Senior Director, Data Management will lead the data management strategy, ensuring quality and governance across data systems, collaborating with internal and external partners, and overseeing compliance with regulatory expectations.
Who is BlueRock?
BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves.
What Are We Doing?
Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.
We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.
We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.
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.
Target Base Salary: $238,000 - $280,900
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BlueRock Therapeutics Company Culture Highlights
Winner of Boston Business Journal's Best Places to Work (Mid-size Company) 2023
Winner of Comparably's Award for Best Company for Diversity 2022
Winner of Comparably's Award for Best Company for Women 2022
Winner of Comparably's Award for Best CEO 2022
BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably.
Engineering Department is ranked in the top 5% of companies for Overall Culture on Comparably.
Check us out on Comparably: https://www.comparably.com/companies/bluerock-therapeutics
Follow us on Linkedin: https://www.linkedin.com/company/bluerocktx/
Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.
Top Skills
Cdisc Standards
BlueRock Therapeutics Cambridge, Massachusetts, USA Office
1 Broadway, , Cambridge, MA, United States
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