Scholar Rock

Director

• Leverage prior in-market, launch, and pipeline experience to support the commercial team in building and executing a robust Global market insights and analytics plan
• Lead compliant primary market research initiatives to generate insights for global commercial and brand strategies
• Manage external competitive intelligence vendors and oversee market landscapes, global congress monitoring, and clinical-stage intelligence
• Identify competitive threats, opportunities, and emerging market dynamics
• Partner with commercial stakeholders on annual brand planning deliverables, including Situational Assessment, Global Market Outlook, and Market Map
• Build relationships with affiliate and cross-functional experts
• Define problems, design research, and synthesize insights to support commercial decision-making
• Communicate insights clearly and crisply to stakeholders
• Synthesize insights into frameworks supporting alignment on launch optimization strategies
• Serve as an organizational and strategic thought partner for data-driven, evidence-based decision-making
• Generate competitive intelligence and market insights for a newly launched neuromuscular treatment and potential new indications

Director, Market Insights

Clinical Research

• Implement clinical project plans in accordance with key study documents, corporate objectives, and regulatory objectives
• Facilitate internal project team meetings
• Drive all aspects of study start-up, including CRO selection
• Serve as point of contact for sites, vendors, and CROs
• Monitor CRO and vendor adherence to scope of work
• Manage investigator and investigative site interactions in accordance with regulatory requirements
• Identify, resolve, and escalate issues jeopardizing timely clinical study completion
• Develop and manage clinical trial budgets and facilitate contract review
• Participate in vendor, site, and CRO audits as appropriate
• Participate in site monitoring visits as necessary
• Plan and present at Investigator Meetings, company meetings, and other meetings
• Develop internal tracking and reporting tools for Leadership study-status reporting
• Adhere to department SOPs, GCP/ICH guidelines, and QC/QA procedures
• Travel internationally and domestically up to 20% as required
• Perform other duties and responsibilities as required

Associate Director – Senior Clinical Trial Manager II

Medical Director

• Provide medical leadership for clinical development activities of assigned pipeline products, including leading efforts to define clinical development strategy and plan
• Collaborate with development and research teams to build a collaborative culture and improve development-team effectiveness
• Lead scientifically robust evaluation of development strategy and plans, including literature review, disease-area assessment, development-landscape analysis, and development/regulatory-pathway evaluation
• Engage external scientific and clinical-trial experts and consultants to develop scientifically robust clinical-study designs
• Author clinical and regulatory documents, including study concepts, protocols, investigator brochures, regulatory documents, and publications
• Lead author clinical responses to regulatory authorities regarding protocols, INDs, BLA/MAA/JNDA, and other regulatory filings
• Provide medical leadership and input across business development, non-clinical development, quality assurance, clinical operations, biostatistics, regulatory affairs, and drug safety
• Provide medical oversight of clinical trials, including medical monitoring, adverse-event reporting, and patient safety
• Provide medical and scientific leadership in data analysis and interpretation while maintaining integrity, rigor, and transparency
• Work within applicable GCP/ICH regulations

Medical Director – Senior Director, Clinical Research

Manager

• Provide statistical leadership for one or multiple clinical studies from Phase 1 through Phase 3
• Provide statistical support for clinical trial design, including healthy volunteer trials, dose-finding studies, efficacy trials, safety trials, and clinical and pre-clinical pharmacokinetic studies
• Conduct statistical analysis and modeling across development stages, including comparing study designs and implementing pre-specified or ad-hoc analyses
• Develop or review Statistical Analysis Plans, mock TFL displays, and programming specifications for analysis datasets
• Ensure high-quality statistical deliverables and lead data interpretation
• Represent biostatistics in study team and clinical development team meetings and lead statistical discussions
• Contribute to randomization schedules and supply management algorithms
• Author statistical sections and contribute to regulatory documents, including clinical protocols, study reports, Investigator Brochures, INDs, briefing documents, and integrated summaries
• Support regulatory interactions with agencies
• Provide oversight of statistical activities outsourced to external vendors
• Contribute to publications and scientific presentations
• Participate in biostatistics activities throughout clinical development, from clinical design to regulatory submission
• Perform day-to-day clinical statistician activities, clinical trial design, statistical analysis development, modeling, simulation, and analysis, and lead statistical deliverables

Senior Manager – Biostatistics

Software Engineer

• Serve as Scholar Rock’s technical lead and subject matter expert for combination products and drug delivery devices.
• Provide hands-on technical leadership across development programs.
• Lead device engineering activities for prefilled syringe, needle safety system, and autoinjector development programs.
• Lead drug-device integration, including primary container/device interfaces, syringe functionality, injection performance, dose delivery, and other critical device performance attributes.
• Define and maintain device user requirements, design inputs, design outputs, traceability matrices, verification/validation plans, and acceptance criteria.
• Develop and maintain design history files, EU technical documentation files, design control documentation, risk assessments, and supporting technical documentation.
• Lead formative and summative human factors engineering and usability studies.
• Partner with Regulatory Affairs and Regulatory CMC on U.S. combination product requirements and EU device requirements, including EU MDR Article 117 and Notified Body Opinion activities.
• Provide technical leadership for device platform evaluation, selection, and lifecycle management.
• Partner with and oversee external consultants, human factors vendors, device development partners, and contract test laboratories.
• Develop scopes of work, manage budgets, and ensure outsourced device-related activities are executed successfully.
• Support device-related investigations, change controls, commercial readiness, and post-approval lifecycle management.
• Establish device engineering processes and best practices as the combination product portfolio grows.
• Collaborate with Drug Product Development, Drug Product External Manufacturing, Regulatory CMC, Quality Control, and Quality Assurance.
• Foster scientific rigor, innovation, collaboration, and continuous improvement.

Senior Director, Device Engineering

Operations

• Own gross-to-net (GTN) actuals-to-forecast reconciliation, including variance investigation and root-cause analysis
• Build reporting and analytics tools with automated validations across GTN, GP, and commercial and government rebates
• Coordinate business process outsourcing (BPO) partners and serve as the first-line escalation point
• Build contract analytics capabilities to support contract performance monitoring and decision-making
• Monitor IRA implementation, CMS rule-making, and other policy changes; assess and communicate business impact to the Pricing Committee
• Manage BPO state price transparency reporting across applicable jurisdictions and monitor the evolving state regulatory landscape
• Maintain the ex-US list/net price reference database supporting international reference pricing analysis and global price corridor monitoring
• Maintain the global price master and price change-control process; ensure price changes are approved, documented, and accurately reflected in downstream systems
• Oversee revenue-leakage mitigation across contracting and compliance, including chargeback and duplicate-discount mitigation, rebate non-compliance, and price-calculation risk
• Manage rebate and chargeback processing and dispute resolution
• Partner with Finance/FP&A and Accounting on quarterly GTN accruals and forecast assumptions
• Strengthen SOX-aligned controls and documentation across contracting and pricing operations
• Prepare deal models and policy impact analyses for Market Access and the Pricing Committee
• Own and optimize pricing and contracting data for analysis
• Evaluate, gain approval for, and implement a duplicate discount vendor solution
• Help build the evidence-based case for Phase 2 hiring and scaling of the function
• Lead and mentor analysts as the team scales, establishing best practices and a center-of-excellence approach

Director, Market Insights

Associate Director – Senior Clinical Trial Manager II

Medical Director – Senior Director, Clinical Research

Senior Manager – Biostatistics

Senior Director, Device Engineering

Director, Pricing & Contracting Operations