Director, Research & Development Technology

Position Responsibilities 

Strategic Development Business Partnership

• Serve as the lead IT partner across Clinical Operations, Data Management, and Biometrics
• Translate scientific, regulatory, CMC, and safety strategy into a multi-year development digital roadmap
• Partner with executive leaders across R&D, CMC, Regulatory, Safety, and Quality to identify opportunities where technology, data, and AI accelerate decision-making, improve compliance, and reduce cycle time
• Represent IT within Development leadership forums and influence enterprise strategy across the product lifecycle

Development Domain Architecture & Application Strategy

• Own the technical architecture across Scholar Rock’s Development digital ecosystem, including scientific research, translational sciences, preclinical, R&D operations, CMC, Regulatory, and Safety systems
• Ensure systems, data, and AI capabilities scale with Scholar Rock’s pipeline, regulatory expectations, and global operating footprint
• Lead lifecycle management of scientific, regulatory, safety, and CMC applications
• Define architectural standards, integration patterns, master data models, and interoperability across scientific, regulatory, safety, CMC, and enterprise systems
• Partner with Enterprise Applications, Cybersecurity, and Network Platform Engineering to ensure Development platforms are secure, reliable, and aligned with enterprise standards

R&D, Translational & Preclinical Enablement

• Provide architecture and delivery leadership for research, translational, preclinical, and R&D operations
• Support biomarker development, PK/PD workflows, in vivo studies, and translational analytics
• Support imaging, omics, and high-content workflows where applicable

CMC Technology Enablement

• Own technology capabilities supporting CMC development, process development, analytical development, and CMC operations
• Enable technology continuity across R&D → CMC transitions
• Partner with Quality and Manufacturing Technology on validated systems, data integrity, and lifecycle continuity

Regulatory & Safety Technology

• Own technology strategy and delivery for Regulatory Affairs, Safety, and Medical Writing platforms, including RIM, safety systems, submission platforms, and document management
• Ensure systems and data support inspection readiness, submission planning, safety case management, and lifecycle management
• Partner with Regulatory, Safety, and Quality to ensure global compliance and audit readiness

Data, AI & Scientific Computing

• Partner with Enterprise Data & AI to define data flows across R&D, CMC, Regulatory, and Safety into Scholar Rock’s enterprise data platform
• Enable structured data products for scientific, translational, regulatory, CMC, and safety domains
• Partner with Enterprise Data & AI to design and operationalize generative and agentic AI capabilities across development workflows
• Architect secure scientific computing environments and Trusted Research Environments (TREs) to support sensitive datasets and controlled access
• Enable responsible AI practices for development use cases

External R&D + CMC Ecosystem Enablement

• Partner with R&D Operations and CMC leaders to enable seamless collaboration with CROs, CDMOs, contract testing labs, and academic collaborators
• Define secure data exchange models, validated interfaces, and vendor connectivity patterns
• Support the operating model for external partner integrations, including data ingestion, workflow interoperability, and validated interfaces

Cross-Lifecycle Alignment

• Partner with Research, Development, CMC, Regulatory, Safety, and Quality to ensure digital capabilities support scientific and portfolio priorities across the product lifecycle
• Provide architecture guidance for cross-functional lifecycle data continuity across Discovery → Clinical → CMC → Regulatory → Safety
• Enable seamless data exchange, workflow interoperability, and validated interfaces across development-adjacent functions

Delivery, Governance & Operating Model

• Establish and mature the Development IT operating model, including product management, engineering, application support, vendor management, and validation
• Establish governance and standards for validation, GxP/GLP, data integrity, information security, and audit readiness
• Own delivery of Development IT initiatives, ensuring scope, quality, cost, timeline, and risk are actively managed
• Serve as the executive escalation point for R&D, CMC, Regulatory, and Safety technology issues and delivery risks

Cross-Functional Partnership

• Partner with Enterprise Data & AI, Enterprise Applications, Network Platform Engineering, Cybersecurity, Digital Workplace, and Quality/CSV to ensure Development platforms are integrated, secure, reliable, and compliant

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  Partner with Procurement, Finance, and Legal on vendor selection, contracts, and cost governance

Team & Talent Leadership

• Build and develop a high-performing Development IT team, including product management, business analysis, architecture, engineering, and application support
• Foster a culture of scientific curiosity, delivery excellence, compliance rigor, and pragmatic problem-solving
• Establish talent, growth, and capability development paths as the function scales

Candidate Requirements

• Bachelor’s degree in Computer Science, Engineering, Data Science, Life Sciences, or related field (or equivalent experience)
• 10+ years of progressive IT leadership supporting Development functions including R&D, CMC, Regulatory, or Safety in biotech or pharma
• Demonstrated architectural depth across scientific, CMC, regulatory, or safety systems
• Demonstrated business partnership with senior scientific, CMC, regulatory, safety, and quality leaders
• Strong understanding of GxP, GLP, CSV, data integrity, and regulated life sciences environments
• Experience integrating domain systems with enterprise data platforms (e.g., Snowflake, Databricks) in partnership with centralized teams
• Practical experience applying modern data engineering, generative AI, and agentic AI in life sciences environments
• Excellent executive communication and stakeholder-management skills