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Scholar Rock

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Senior Manager, GxP Applications & Data

Cambridge, MAOn-siteFull-time

AI Summary

The Senior Manager, GxP Applications & Data serves as the technology lead for enterprise applications and data supporting Quality, Clinical, Regulatory, and Safety organizations, leading solution delivery and platform operations for GxP solutions.

About this role

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:

The Senior Manager, GxP Applications & Data serves as the technology lead for enterprise applications and data supporting Scholar Rock’s Quality, Clinical, Regulatory, and Safety organizations. Scholar Rock has established a strong foundation of GxP applications and technology capabilities, with Veeva serving as a core strategic platform. This role will help mature, scale, and operationalize that foundation as the company advances through late-stage development, commercialization readiness, and global growth.

Reporting to the Senior Director, Commercial & Data, the Senior Manager partners closely with business stakeholders, Quality and Validation, Cybersecurity, Data & Analytics, Infrastructure & Cloud, and external technology partners to translate business priorities into scalable, secure, compliant, and sustainable technology solutions.

The role combines strong technical expertise with application ownership and delivery leadership. The Senior Manager leads solution delivery from requirements and design through implementation and ongoing support, maintains sufficient hands-on expertise to independently assess, configure, and troubleshoot complex Veeva solutions, and ensures internal and external delivery teams provide reliable, high-quality services.

The successful candidate will be comfortable moving between business conversations and technical decisions - understanding stakeholder priorities, shaping solutions, managing delivery and operational outcomes, and engaging directly with the technology when deeper expertise is required.

Position Responsibilities

Business Partnership & Solution Delivery

  • Serve as a trusted technology partner to Quality, Clinical, Regulatory, and Safety stakeholders, developing a strong understanding of business priorities, processes, and evolving technology needs.
  • Translate business and regulatory requirements into solution options, technical requirements, delivery plans, and measurable outcomes.
  • Partner with the Senior Manager, Commercial Application and Data to execute the platform roadmap and align demand, priorities, dependencies, and delivery sequencing.
  • Lead implementations, enhancements, integrations, releases, and continuous improvement initiatives across the GxP application portfolio.
  • Communicate solution recommendations, delivery status, risks, dependencies, and tradeoffs clearly to business and technology stakeholders.
  • Partner with business stakeholders to improve data quality, data stewardship, reporting enablement, and the effective use of application data supporting GxP business processes.
  • Operate with a high degree of independence and judgment, making day-to-day application, technical, delivery, and operational decisions within established platform strategy and governance.

    • Application & Technical Leadership

  • Provide technical leadership for Veeva and related GxP applications across solution design, configuration, integration, security, and lifecycle management.
  • Design and configure complex Veeva Vault solutions when needed and maintain the technical depth required to troubleshoot issues, assess alternatives, and independently validate partner recommendations.
  • Establish scalable configuration, integration, security, and release practices that improve consistency, maintainability, and supportability.
  • Lead technical design for integrations between Veeva and adjacent applications, data platforms, identity services, middleware, APIs, and other regulated technologies.
  • Partner with Cybersecurity, Data & Analytics, Infrastructure & Cloud, Quality, and Validation to ensure solutions align with enterprise standards and regulatory requirements.

    • Application Lifecycle & Operational Excellence

  • Own the day-to-day health, performance, supportability, and service quality of assigned GxP applications.
  • Ensure applications remain reliable, secure, compliant, scalable, and aligned with changing business requirements.
  • Lead release planning, impact assessments, change execution, deployment readiness, and post-production support.
  • Establish and monitor application health, service, delivery, quality, and adoption measures and use them to drive continuous improvement.
  • Identify recurring issues, technical debt, lifecycle risks, and service gaps and drive appropriate remediation.
  • Ensure effective incident, problem, change, enhancement, and escalation management across applications within scope.

    • Vendor & Delivery Management

  • Lead managed service providers, systems integrators, consultants, and other external partners supporting the GxP application portfolio.
  • Establish clear service, delivery, technical, and quality expectations and hold partners accountable for outcomes.
  • Review and challenge vendor recommendations and technical solutions, ensuring decisions align with business requirements, architecture standards, and long-term application strategy.
  • Manage delivery priorities, dependencies, escalations, risks, and performance across internal and external resources.
  • Ensure effective documentation, knowledge transfer, operational readiness, and support transition for new and changed solutions.
  • Build internal application knowledge and capability while using external partners strategically for capacity and specialized expertise.

    • GxP, Validation & Compliance

  • Maintain the technical validated state of assigned applications and ensure changes remain appropriately controlled throughout the application lifecycle.
  • Partner with Quality and Validation on validation strategy, impact assessment, testing, technical documentation, and remediation.
  • Ensure solutions appropriately address applicable GxP requirements, electronic records and signatures, data integrity, access controls, audit trails, and regulated change requirements.
  • Support regulatory inspections and audits and coordinate technical response and remediation for application-related observations.
  • Promote practical, risk-based validation and compliance practices that support both regulatory expectations and sustainable technology delivery.

    • Knowledge & Skills

  • Strong hands-on knowledge of Veeva Vault architecture, configuration, integrations, security, and application lifecycle management.
  • Strong understanding of enterprise application delivery, operations, support, and service management.
  • Demonstrated ability to translate business requirements into practical technology solutions and successfully lead those solutions through implementation and operation.
  • Experience managing vendor-delivered technology services and providing technical oversight to systems integrators and managed service providers.
  • Strong working knowledge of regulated GxP technology environments, computerized system validation, data integrity, and inspection-readiness expectations.
  • Ability to independently assess complex business and technical issues, make sound decisions, resolve ambiguity, and engage specialized expertise when appropriate.
  • Strong stakeholder management, communication, prioritization, problem-solving, and decision-making skills.
  • Ability to balance business priorities, technical sustainability, regulatory requirements, operational risk, and delivery commitments.

    • Candidate Qualifications

    • Bachelor's degree or equivalent combination of education and relevant experience.
    • 8+ years of progressive experience in enterprise applications, technology delivery, application management, or related disciplines, preferably within pharmaceutical, biotechnology, or life sciences.
    • 4+ years of hands-on experience implementing, configuring, supporting, or delivering Veeva Vault solutions across Quality, Clinical, Regulatory, Safety, or related regulated functions.
    • Experience across Veeva Vault applications supporting Quality, Clinical, Regulatory, and Safety, such as QualityDocs, QMS, Training, Clinical Operations, RIM, and Safety.
    • Experience leading implementations, enhancements, integrations, releases, and operational support for enterprise applications in validated GxP environments.
    • Experience managing technology delivery involving managed service providers, systems integrators, consultants, or vendor-delivered solutions.
    • Experience serving as a platform owner, technical lead, solution delivery lead, or comparable technology leadership role supporting regulated applications.
    • Experience establishing trusted relationships with business stakeholders and translating complex business and regulatory needs into technology outcomes.
    • Demonstrated ability to independently assess complex business and technical issues, make sound decisions, resolve ambiguity, and drive solutions through implementation and ongoing operation.
    • Working knowledge of pharmaceutical regulatory requirements as applied to technology, including 21 CFR Part 11, computerized system validation, data integrity, and inspection readiness.
    • Veeva Vault certification or advanced experience across multiple Veeva applications.
    • Deep familiarity with the Veeva ecosystem (Vault, Network) and its data integration patterns.
    • Experience leading application delivery teams, platform teams.
    • Experience supporting data quality, data stewardship, reporting enablement, or data governance initiatives within regulated environments.
    • Experience applying CSA principles and risk-based validation approaches.
    • Experience integrating Veeva with ERP, data and analytics, middleware, identity, clinical, regulatory, or quality platforms; SAP experience is a plus.
    • Prior experience in rare disease, specialty pharma, or biotechnology supporting regulated R&D and Quality operations.
    • Experience supporting late-stage clinical development, commercialization readiness, and the growth of global regulated operations within a biotechnology or pharmaceutical organization.
    • ITIL, Product Management, Agile, Project Management, or related certifications preferred.

    • Skills

    21 CFR Part 11Computerized System ValidationCybersecurityData IntegrityGxPITILQuality Management SystemSAPVeeva VaultVega

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