Lead strategy and delivery of IT systems for R&D, CMC, Regulatory, and Safety. Define architecture, data/AI integration, and secure scientific computing (TREs). Drive Laboratory of the Future (AI, robotics, data science), vendor integrations, validation/GxP compliance, governance, and build a Development IT team to support global product lifecycle and inspection readiness.
Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the Company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
Summary of Position:
Scholar Rock is seeking a Director of Research and Development Technology to cultivate strong functional partnerships to develop strategic solutions to Scholar Rock’s growing research and development pipeline. This position, reporting to the Chief Information Officer, is a pivotal role in the IT organization as the company transitions to a global commercial operation. In this role, you will lead the strategy, delivery, and manage the lifecycle of IT systems across Research, Clinical Development, Regulatory, and Pharmacovigilance. In addition, the Director will develop and lead the Laboratory of the Future initiative to incubate the usage of Artificial Intelligence, Robotics, and Data Science.
This role requires a dynamic and passionate individual, combining strategic business partnership with hands-on support in conjunction with our managed service provider.
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
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
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Scholar Rock Cambridge, Massachusetts, USA Office
301 Binney St, , Cambridge, Massachusetts , United States, 02142
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