Scholar Rock

Director

• Lead account planning, management, and engagement activities at assigned payers to achieve rapid and clinically appropriate access for patients.
• Support development of apitegromab’s value proposition and other supporting materials, including any account-specific needs
• Maintain a strong understanding of apitegromab Commercial objectives and how to help achieve these goals through assigned accounts
• Work across teams to ensure patient access objectives are met, including pull-through
• Ensure all programs are aligned to Scholar Rock values and remain compliant with regulations
• Lead presence with target accounts at access-related meetings, events and congresses (e.g., AMCP, PCMA, Asembia, Medicaid meetings, etc.)
• Collaborate with Insights and Analytics and Commercial Operations to derive account-level insights and actions; communicate access and coverage performance regularly to internal stakeholders
• Proactively identify and execute against opportunities to improve patient access to care, within and outside of Value & Access
• Be a content expert on relevant industry trends, market dynamics, policy and legislation and define implications and actions for Scholar Rock
• Be a collaborative, strategic market access presence throughout the Scholar Rock organization

Director, National Accounts

Clinical Research

• Implement clinical project plans in accordance with key study documents (e.g. protocols, project plans and timelines, etc.) as well as corporate and regulatory objectives
• Facilitate internal project team meetings
• Ensure trial master file (TMF/eTMF) is established, current, and maintained.
• Drive all aspects of study start-up, including CRO selection
• Point of contact for sites, vendors and CROs
• Monitor CRO and vendor adherence to scope of work
• Manage interactions with investigators and investigative sites to ensure activities are conducted in accordance with all regulatory requirements
• Proactively identify, resolve, and escalate issues that jeopardize timely clinical study completion
• Develop and manage clinical trial budget 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, and other meetings as necessary
• Develop internal tracking and reporting tools for reporting study status to Leadership
• Adhere to all department SOPs, GCP/ICH guidelines, and QC/QA procedures
• May require international and domestic travel (up to 20%)
• Other duties and responsibilities as required

Senior Clinical Trial Manager

Vice President

• Shape and lead value and access submission and negotiation planning, including optimal country launch sequence
• Ensure sustainable access in key European markets
• Work cross-functionally to influence long-term growth and patient impact, building a global multi-billion company serving patients suffering from rare neuro-muscular diseases
• Lead market access launch of apitegromab for spinal muscular atrophy (SMA) starting with Germany
• Adapt Global market access strategies and tactics for these markets, including drug distribution, value proposition, pricing, health technology assessment, and economic modeling
• Cultivate relationships with key payers and stakeholders who influence payers
• Compellingly communicate clinical and economic value of apitegromab to these stakeholders
• Lead payer negotiations at the national, regional, and local levels
• Manage relevant market access vendors, resources, and budget
• Represent EMEA Value & Access on apitegromab Global and Country teams
• Effectively communicate insights, strategies, voice of access customers, and implications to leadership

Vice President, Market Access, EMEA

• Serve as the EUR Responsible Scientific Officer
• Lead the development and execution of the EMEA medical affairs strategy in alignment with global objectives
• Provide medical insights to support business and regulatory decisions
• Collaborate with cross-functional teams (clinical development, clinical operations, regulatory affairs, commercial, and market access) to ensure scientific alignment and strategic focus.
• Collaborate to develop medical strategy and content as appropriate for congresses, symposia and advisory boards and facilitate and execute such activities in Europe
• Ensure the dissemination of accurate, balanced, and scientifically sound medical information
• Lead the development and approval of region-specific scientific publications, presentations, and other communication materials
• Delivers scientific presentations to diverse audiences (e.g. physicians, pharmacists, marketing/medical agencies, and other key stakeholders) in meetings, advisory and/or consulting settings
• Represent the company at key scientific and medical conferences and engage with external stakeholders
• Develop and maintain relationships with top regional KOLs, HCPs, and patient advocacy groups across Europe
• Engage in meaningful dialogue with external experts to gather insights, feedback, and strengthen partnerships
• Support the co-development and sign off of promotional materials and campaigns, in the prelaunch and the launch phase and set up appropriate medical review procedure to make such materials compliant in EUR
• Indirect leadership to country medical affairs leaders
• Provide medical support to clinical development and clinical research conducted in Europe such as the identification of medical centers of excellence and key investigators/sites in such programs, support operational tasks such as investigator meetings and targeted patient recruitment efforts
• Continuously maintain deep scientific and medical knowledge of Spinal Muscular Atrophy and a deep understanding of patient and physician interactions and clinical decision making and impact
• Assess medical education needs in Europe and develop internal and external educational strategy as needed
• Provide EU region medical monitoring support for all clinical programs where needed
• Coordinate investigator-initiated studies and foster collaboration with academic institutions
• Ensure that all medical affairs activities are conducted in compliance with regional regulatory requirements, ethical guidelines, and company policies
• Support regulatory submissions, product launches, and post-marketing surveillance activities
• Lead and mentor a team of medical affairs professionals across the region
• Foster a culture of continuous learning and development within the medical affairs team

Vice President, Medical Affairs – EMEA

Financial Planning and Analysis

• Serve as the primary finance partner for R&D leadership, Program Management, Clinical Development, Research and Regulatory
• Support for all FP&A activities including budgeting/forecasting, long-range planning, scenario modeling and financial analysis for strategic initiatives
• Coordinate with accounting on month-end and quarterly close tasks, procure-to-pay processes, preparation of quarterly schedules, and support of external reporting and related audit inquiries
• Develop timely analysis of monthly budget-to-actuals including variance analyses, generation and reporting of results
• Strive for continuous improvement of FP&A processes, with the goal of improving efficiency while maintaining flexibility to adapt to future business needs
• Develop and deliver training initiatives and provide support for change management activities to ensure adoption of new FP&A tools, systems and mindsets across the organization
• Support ad-hoc strategic initiatives including business development analyses, partner support, portfolio prioritization, and financing strategies
• Reporting to the Sr. Director, FP&A and supporting R&D and pipeline programs; act as strategic partner in framing, evaluating, and driving decision making to maximize value creation
• Help build cross-functional FP&A capability at a growing, multi-product candidate biotechnology company

Director, Financial Planning and Analysis – R&D

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

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).

Director/Senior Director, Quality Systems and GxP Compliance

• 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.