Senior Manager, GxP Applications & Data

Scholar Rock, Inc.; Cambridge, Northern (MA, KY); Hybrid; USD 170,000 - 210,000; Full time

Job summary

Scholar Rock, Inc. seeks a Senior Manager, Veeva Regulatory & Data to lead enterprise applications and data across Quality, Clinical, Regulatory, and Safety.

The role drives Veeva Vault strategy, platform roadmap, and secure, scalable solutions as the company advances late-stage development and commercialization readiness. The candidate partners with stakeholders, cybersecurity, data analytics, and external vendors to deliver compliant technology that supports fast, reliable regulatory processes

Responsibilities

• Serve as the technology lead for enterprise applications and data for Quality, Clinical, Regulatory, and Safety.
• Lead implementations, enhancements, integrations, releases, and continuous improvement across the GxP portfolio.
• Design and configure Veeva Vault solutions and troubleshoot complex issues.
• Collaborate with cybersecurity, data analytics, infrastructure, and external partners to ensure compliant, scalable solutions.
• Translate business priorities into scalable technology strategies and roadmaps.

Skills

Veeva Vault

GxP applications

Data governance

Stakeholder partnership

Technical leadership

Tools

Veeva Vault configuration

API integrations

Job description

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 Rockworks 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, Veeva Regulatory & 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, Veeva Commercial 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