Scholar Rock

Title: Director, Vendor Quality Management Location: Cambridge United States 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 Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Summary of Position: Scholar Rock is seeking an experienced and motivated Director of Vendor Quality Management. Reporting to the Senior Director, Global Quality Systems and Compliance, this position will oversee vendors and service providers that impact GxP activities. Position Responsibilities - Lead the implementation of a global, risk-based GxP vendor oversight program aligned with industry best practices and global regulatory expectations (e.g., ICH Q9, data integrity principles, and applicable GxP requirements), ensuring scalability to support commercial operations. - Establish and operationalize an end-to-end vendor lifecycle management framework, including vendor selection, qualification, onboarding, performance monitoring, issue and CAPA management, change management, periodic review, requalification, and vendor termination activities. - Develop and implement a tiered vendor segmentation and risk methodology, defining vendor criticality classifications, risk scoring criteria, oversight requirements, and triggers for enhanced monitoring and requalification activities. - Build and mature a right-sized audit and monitoring program proportional to vendor risk and criticality, including risk-based audit planning, remote and on-site audit strategies, audit execution standards, and integration of audit outcomes into CAPA and management review processes. - Define and implement vendor oversight governance mechanisms, including KPIs, dashboards, management review processes, escalation pathways, and periodic business reviews to enable proactive performance and compliance management. - Partner cross-functionally with Quality, Supply Chain, Manufacturing, Technical Operations, Regulatory, and IT teams to ensure alignment of vendor oversight activities with business objectives and regulatory expectations. - Lead technology enablement efforts supporting vendor oversight processes, including assessment and optimization of eQMS and related systems (e.g., Veeva Vault), definition of workflows, user requirements, reporting capabilities, and configuration enhancements to support scalable execution and visibility. - Provide strategic oversight of vendor-related quality risks and compliance issues, ensuring appropriate escalation, investigation, remediation, and continuous improvement activities. - Support inspection readiness and regulatory inspections related to vendor oversight activities, ensuring vendor management processes and records are inspection-ready and aligned with global regulatory expectations. Candidate Requirements - BS/MS degree in a scientific discipline. - 10-15 years of experience in the pharmaceutical/biotech industry, with 5+ years' experience overseeing Vendor Quality Management - Deep understanding of GxP and Quality System requirements (US and EU) for pharmaceutical/biotech manufacturing and development. - Demonstrated experience designing, optimizing, and scaling Quality Management Systems to support evolving organizational needs, including progression toward commercial manufacturing and distribution. - Experience with digital quality systems, including eQMS, Document Management Systems, and Learning Management Systems, with the ability to drive system effectiveness and scalability. - Hands-on experience with systems such as Veeva Vault is preferred. - Highly proactive, decisive, and capable of independently managing key initiatives. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

• Drive patient identification and market development for SMA by building and executing against a territory strategy, account and customer specific plans thereby achieving and exceeding sales goals. • Continuously assesses sales opportunities within markets and accounts to maintain and grow their business. • Able to effectively prioritize time, activities, and resources to optimize accounts with the most sales potential. • Educate and connect HCPs to Scholar Rock services. • Builds and maintains relationships with physicians by maximizing their time through pre-call planning, leveraging insights to tailor a call plan, and conducts post call analysis to continually refine and enhance their approach. • Proactively builds effective working relationships with internal/external stakeholders; can drive agreement/decisions from multiple stakeholders; can read people’s emotions and flex communication style. • Collaborate with stakeholders across commercial, compliance and patient care centers to ensure access at site of care and that logistics are in place to administer. • Can adjust their approach based on different stakeholder needs, concerns, or audience member to drive alignment and meet their work goals. • Collaborate with key accounts and physicians to build individual account plans on how to approach their customers, achieve sales goals, and maintain relationships in order to maximize sales results. • Collaborate with key accounts and physicians to drive patient identification through market development and physician education • Executes promotional programs, in-services, and lunch-and-learns for their territory. • Determines suitable travel schedule and call plan on a daily/weekly basis to ensure adequate coverage for all key accounts.

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn. Summary of Position: The MSL/Sr MSL role will represent the real time voice of KOL/HCP input related product development opportunities and scientific exchange on pipeline and commercial products; conduct clinical presentations to payer organizations. The ideal candidate will be a strong leader with a proven ability to leverage their high scientific acumen to engaged and educate on scientifically complex concepts and products. The preferred candidate will also have a proven strategic and innovative style combined with a flexible, hands-on nature that works with a high sense of urgency. Position Responsibilities - Become a SMA and apitegromab medical/clinical/scientific expert - Build and foster relationships with local, regional, and national KOLs and possibly Payers - Effectively deliver medical/clinical/scientific presentations to a diverse external audience - Support clinical development activities, investigator recruitment and education - Development and execution of their Territory Management Plan (TMP) that is aligned with the overall Medical Goals and Plan - Contribute to developing metrics, qualitative and quantitative MSL reports, SOPs/Business Practices for the MSL function - Responding to unsolicited medical information requests submitted by SRRK field teams (eg. Sales and Market Access) - Compliantly partner with Sales and Market Access on high-level regional engagement - Provide internal teams with insights from interactions and discussions with HCPs - Co-create and deliver the MSL training - Provide content development support for MSL materials, alongside the Director of Medical Communications - Contribute to the development of the Global and US Medical Plans for apitegromab in SMA - May be asked to participate in Advisory Board meeting, Advisory Group meetings, speaker trainings, etc. - Coordinate local and regional investigator-initiated research (IIR) - Compliantly manage IIR milestones and objectives - Report on scientific sessions and conduct scientific exchange to unsolicited questions at SRRK medical booths at congresses - May respond to and document unsolicited requests for scientific information - Conduct all activities and responsibilities in accordance with all relevant legal, regulatory and corporate regulations and guidelines, including the Scholar Rock Business Conduct & Ethics, policies and procedures Candidate Requirements - MD, PharmD, or PhD preferred. Advanced professional degree (NP, PT etc) may be considered for candidates with significant clinical neuromuscular disease experience - Neurology and/or rare disease experience with prior launch experience preferred - Demonstrated knowledge of regulatory, commercial and clinical issues affecting the pharmaceutical industry is critical - Excellent verbal and written communication, presentation, and interpersonal skills are essential - Demonstrated strategic planning, organizational and project management abilities are required - Ability to collaborate in a team environment and partner effectively across geographic areas and cross-functional groups is essential - Experience in at least one “start-up” biopharma company is desirable. - Must be passionate about making a difference with the highest integrity; committed to ethics and scientific standards - Demonstrated ability to work independently yet engage in collaborative decision making to complete tasks in a timely fashion, and function in a rapidly paced environment - Experience with customer relationship management programs a plus - This will be a remote position that will require extensive overnight travel (>50%). $175,000 - $250,000 a year Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

• Lead account planning, management, and engagement activities at assigned payers to achieve rapid and clinically appropriate access for patients. This includes establishing and further developing relationships with decision makers at key customers • 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

• Provide ongoing support through tailored, field-based education on reimbursement processes to HCPs and infusion site/institutional stakeholders. This includes hospitals, academic institutions, private group practices, specialty pharmacies, and alternate treatment sites. • Develop and execute strategic, patient-centric plans and account-specific initiatives to ensure access, affordability, and support for patients at various stages of their treatment journey. • Build and maintain collaborative, strategic relationships with healthcare organizations and aligned stakeholders (internal and external) that may impact patient access to therapy. • Analyze data and use customer insights to identify barriers to access, making data-driven decisions to prioritize activity and optimize access pathways. • Foster strong relationships and facilitate effective communication with cross-functional partners in market access, patient services, sales, and medical. • Provide education and support to internal teams, equipping colleagues with the knowledge and tools to address access and reimbursement challenges quickly and successfully. • Ensure compliance with all relevant regulations and standards in the delivery of patient support and handling of PHI. • Stay informed on healthcare policies, reimbursement trends, and regulatory requirements to address challenges and opportunities in the marketplace.