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
Skills Required
- 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 (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
- Experience with validated systems, submission platforms, and document management for Regulatory and Safety (inspection readiness)
- Excellent executive communication and stakeholder-management skills
What We Do
Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn. For additional information on our guidelines, please visit https://scholarrock.com/community-guidelines/ For more information on how Scholar Rock collects, uses, and shares personal information, please visit: https://scholarrock.com/privacy-policy
