Scholar Rock

Chief Technology Officer

• Ensure reliable IT operations and service delivery for employees, labs, and field teams.
• Build a customer-focused IT culture with clear governance, metrics, and accountability.
• Modernize collaboration and productivity platforms to improve hybrid work and global connectivity.
• Define and execute a visionary IT strategy aligned with Scholar Rock’s scientific, operational, and commercial goals.
• Enable data-driven decision-making through modern data platforms, analytics, and integration across R&D, clinical, supply chain, G&A, and commercial functions.
• Explore and implement emerging technologies (cloud, AI/ML, digital engagement) to create competitive advantage.
• Serve as a thought partner to the Executive Team and the business on technology investments and digital transformation.
• Provide frequent updates to the Executive Team and Board on IT performance, risk management, and progress toward strategic objectives.
• Oversee implementation and compliance of GxP systems across manufacturing, quality, supply chain, and pharmacovigilance.
• Deliver validated enterprise applications (ERP, QMS, LIMS, serialization, data platforms) that are scalable for commercial operations.
• Lead deployment of commercial IT systems: CRM platforms for field force effectiveness (e.g., Veeva, Salesforce); commercial data hub/data warehouse; field force enablement tools to support omnichannel engagement, analytics, and reporting.
• Build and optimize G&A systems including Finance/ERP systems to support SOX compliance and reporting; HRIS/HCM platforms; procurement, contracts, and compliance tools for a public company environment.
• Build a robust cybersecurity program to protect sensitive clinical, commercial, employee, and patient data.
• Ensure compliance with GDPR, HIPAA, SOX, and other global data regulations.
• Develop scalable IT infrastructure and networks to support Scholar Rock’s international expansion.
• Establish and scale a global IT organization with the right mix of internal talent and external partners.
• Define the operating model, including in-house IT leadership, managed service providers, and strategic vendors.
• Build an IT team capable of supporting 24/7 operations across regions, with clear roles in workplace support, GxP/commercial systems, cybersecurity, and enterprise applications.
• Develop succession planning, talent pipelines, and governance structures for long-term scalability.

Chief Information Officer / VP of Information Technology

Vice President

• Set the scientific and operational strategy for Preclinical Sciences, encompassing nonclinical safety, DMPK, and bioanalytical sciences.
• Serve as a senior leader within the Research organization, collaborating closely with Discovery, Clinical Development, Regulatory, and Quality to drive candidate advancement and risk mitigation.
• Provide thought leadership and decision-making support on IND readiness, dose/exposure rationale, and safety margins.
• Represent Preclinical Sciences in governance forums and cross-functional portfolio planning.
• Provide strategic leadership in selecting and managing third party vendors that meet industry standards.
• Oversee GLP and non-GLP toxicology studies in partnership with internal scientists and external CROs.
• Direct in vitro and in vivo DMPK studies, including pharmacokinetic studies to enable and inform clinical modeling and translational assessments.
• Lead integration of bioanalysis, toxicokinetics, and potentially biomarker strategy into nonclinical programs to inform clinical development and regulatory submissions.
• Drive the development of translational hypotheses and mechanistic understanding of safety, and PK/PD in relevant models.
• Provide key scientific input to cross-functional program teams on preclinical results, their implications for clinical/regulatory strategy, and risk mitigation plans.
• Lead and inspire a high-performing internal team spanning toxicology, DMPK, and bioanalytical development; foster a culture of scientific rigor, collaboration, and accountability.
• Own the strategy and preparation of preclinical sections of regulatory submissions (IND, CTA, IB, BLA, briefing packages, etc.), in collaboration with regulatory and clinical colleagues.
• Represent preclinical development in portfolio planning, due diligence, and external collaborations/partnerships.
• Participate in regulatory agency interactions as the scientific lead for nonclinical safety, DMPK, and PK/PD.
• Cultivate productive partnerships with CROs, and external consultants, to expand capabilities and ensure quality.

Vice President, Preclinical Sciences

Compliance

• Serve as the Quality Lead for Quality Systems and Compliance operations across the company and manage quality and compliance guidance to the quality function.
• Oversee and manage GxP Training, Document control, and QMS GxP operations—including change controls, deviations, CAPAs, complaints, audit records, and supplier management activities.
• Track and manage the lifecycle of quality system records to uphold the integrity and compliance of Scholar Rock’s Quality system.
• Ensure timely intake and triage of product complaints, accurate complaint documentation, timely escalation, and proper reconciliation with related systems and departments.
• Assign and manage GxP training via training system, monitor compliance, and generate training completion reports, as needed.
• Participate in validation efforts for new or updated GxP IT systems through review of documentation, execution of test scripts, and supporting change controls as needed.
• Compile and provide metrics related to Quality management system and suppliers for periodic Quality management review meetings.
• Implement and oversee Scholar Rock’s internal audit program.
• Facilitate continuous improvement initiatives to transform and maintain compliance, improving QMS business process efficiency.
• Support inspection readiness activities, as needed.
• Support regulatory submissions including but not limited to annual reports, IND/CTA updates, and/or marketing authorizations.
• Lead and manage the Quality Systems and Compliance team, including direct reports.
• Collaborate with the Head of Quality and site leadership to ensure alignment with corporate goals, customer expectations, and regulatory obligations (FDA, EU, and other global regulators).

Chief Information Officer / VP of Information Technology

Vice President, Preclinical Sciences

Director/Senior Director, Quality Systems and GxP Compliance