Scholar Rock

Director

• Lead the drafting and negotiations of contracts customary to a biotech company in the process of launching its first product, with a primary focus on Development, Research, CMC/Technical Operations, and IT contracts.
• Manage and maintain contracts management system and associated contracting processes, including providing company-wide trainings.
• Provide legal support across the organization, including quickly and effectively identifying complex legal and compliance issues and providing advice in a manner that integrates legal risk management with the company’s business objectives.
• Ability to work in a fast-paced environment, prioritize tasks, and successfully manage multiple projects.
• Develop and maintain strong business relationships across the company and contribute to cross-functional or departmental projects and teams.
• Maintain a positive team culture.
• Manage and complete any additional projects or legal matters as needed, including general corporate matters.

Contracts Director

Accounting Manager

• Oversee and lead all accounting operations activities
• Help to build and scale accounting operations team
• Ensure strong internal control environment is maintained
• Assist in setting up policies related to travel and transparency reporting
• Position will also require partnership with various members of cross functional teams
• Assist in ad-hoc projects as needed

Director of Accounting Operations

Communications

• Develop and execute a comprehensive, global communications strategy that supports business priorities, enhances reputation, and drives stakeholder trust.
• Architect the corporate re-branding including mission, vision, values, and corporate narrative with the COO, CEO, and executive team.
• Evolve the company’s communications platform and messaging to align with the company’s strategic priorities and brand.
• Act as a strategic communications advisor to the COO, CEO and executive team and lead all matters of corporate narrative, media positioning, and communications risks.
• Serve as steward of the company’s voice, ensuring consistency, clarity, and mission-driven across channels and audiences.
• Partner with the COO, CEO and business leaders to craft impactful narratives that reinforce vision, performance, and values. Shape and oversee all executive messaging, visibility, and thought-leadership.
• Work with COO and CEO on internal and external communications, including speaking opportunities, internal employee forums, board communications, media, etc.
• Work in close partnership with Investor Relations, the CEO and executive team to shape and evolve the company’s investor narrative.
• Ensure alignment between financial performance, strategy articulation, and brand reputation.
• Support earnings call preparation, shareholder letters, and investor day communications, etc.
• Lead the coordination, development and execution of integrated external communications strategies aligned with corporate and business objectives.
• Elevate and drive social media strategy, content planning, and performance analytics across platforms.
• Draft and oversee press releases, executive communications, thought leadership content, media statements, and corporate messaging materials.
• Serve as primary media contact and cultivate relationships with industry, biotech/pharma, and business media.
• Lead and manage issues and crisis communications planning and response.
• Develop and maintain strong relationships with key journalists, industry influencers, and thought leaders.
• Guide and manage agencies to deliver high-quality work that reflects the company’s strategy, voice, business and goals.
• Lead communications for all events and congresses to ensure a positive experience and ROI for external customer-facing events. (R&D Day, CureSMA, JPM, etc.)
• Work in partnership with key leaders on their event plans and objectives. Partner cross-functionally with Medical Affairs, Patient Advocacy, Marketing, Regulatory, Compliance et al to ensure messaging alignment and compliance.
• Oversee the successful execution of external events, from budgeting, negotiating contracts, planning to on-site management.
• Inspire and inform a global workforce through strategic internal communications aligned with culture, change, and business priorities.
• Support executive visibility and alignment through town halls, company intranet, and other leadership cascade tools.
• Elevate internal communications using modern and new methods to increase understanding of company priorities, reinforce strategy and values, invite participation, and improve employee engagement.
• Partner with the CBO and Brand leader to ensure alignment between brand strategy and communications narratives across paid, owned, and earned channels.
• Partner with Global Commercialization and Marketing teams to launch products/solutions through storytelling, press releases, media outreach, and high-impact earned channels.
• Lead enterprise response to reputational issues, crisis events, and sensitive situations with strategic thought, clear guidance, and control.
• Ensure the organization is prepared through robust crisis communication planning, risk monitoring, and stakeholder alignment.
• Design, build and lead a high-performing, global communications team.
• Lead with strategy, and guide team on priorities that will make the highest impact.
• Operate as a collaborative enterprise leader, modeling partnership and influence across functions and geographies.

Vice President, Global Head of Communications

• 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

Director, National Accounts – Northeast

Compliance

• Serve as a thought leader on regulatory affairs, defining global regulatory strategy and plan to maximize regulatory success.
• Serve as the global regulatory lead, providing strategic and operational input on assigned clinical and/or pipeline programs, such as the subcutaneous (IV to SC) and OPAL (<2 years old) program teams to achieve program objectives while ensuring compliance with applicable regulatory requirements in the region.
• Be responsible for leading the global supplemental/type 2 variation filing lead for OPAL (<2 years old)
• Develop regulatory roadmap to inform and guide agency engagement strategy; partner with key stakeholders to develop and implement a comprehensive regulatory engagement plan
• Lead and managing regulatory interactions on assigned programs, building trusted relationships with regulatory authorities
• Lead cross-functional effort to ensure timely submission of key regulatory documents (e.g., Module 1, briefing documents)
• Ensure program team members and cross-functional stakeholders are informed of internal and external events that may impact regulatory success
• Identify regulatory risks and opportunities and work with key stakeholders to develop solutions
• Partner with global market access and medical affairs colleagues to support interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable
• Partner with Global and local Marketing/ Commercial as needed to align Regulatory Plan and Marketing/Commercial plan
• Ensure strong representation of regulatory voice at key governance bodies and teams (e.g., DRC, program teams, clinical development teams, study teams)
• Maintain currency of regulatory requirements and approvals to inform regulatory strategies and drive proactive plans to ensure compliance
• Monitor and analyze global and country specific regulatory landscape to assess potential impact on the program; collaborate with teams to ensure compliance
• Provide support to local regulatory experts
• Provide regulatory support for cross-functional activities (e.g., SOPs, business development, clinical labeling, disclosure) as needed

Director/Sr. Director, Regulatory Strategy

Medical Director

• Deliver clinical development plan for pipeline products from Proof-of-Concept through marketing approval and lifecycle management
• Provide medical leadership for clinical development activities of assigned pipeline products
• Collaborate with other members of the development and preclinical research teams to contribute to building a collaborative culture and improving effectiveness of the development team
• Engage with external scientific and clinical trial experts, health authorities, and consultants, to develop scientifically robust development plans
• Provide strategic guidance and support to the late-stage development team, including hands-on authoring, of clinical development plans, study protocols, investigator brochures, regulatory documents, publications, etc.
• Provide medical leadership and input in cross-functional team activities, including business development activities, non-clinical development, quality assurance, clinical operations, biostatistics, regulatory affairs and drug safety
• Responsible for medical oversight of clinical trials, including medical monitoring of studies, adverse event reporting, and patient safety for all clinical trials across a development program.
• Provide medical and scientific leadership in data analysis and interpretation, maintaining integrity, scientific rigor, and transparency
• Work within compliance to all applicable GCP/ ICH regulations

Medical Director – Senior Director, Clinical Research

• Lead the company’s global QC function across a fully outsourced model, with end-to-end oversight of external QC laboratories, CMOs, and contract partners supporting clinical and commercial programs.
• Define and execute the global QC strategy, serving as the internal QC subject matter expert across analytical control strategy, compendial compliance, specification lifecycle management, and stability.
• Provide strategic oversight of stability programs, including protocol design, pull schedule governance, data review and trending, shelf-life support, comparability assessments, and post-approval stability commitments.
• Oversee post-approval specification management, including revision strategy, change assessment, comparability impacts, commitment tracking, and implementation through external partners.
• Ensure effective method qualification, validation, transfer, verification, and lifecycle management across outsourced laboratories, including technical troubleshooting and issue escalation.
• Partner with Analytical Development and CMC teams to support method readiness, control strategy development, and phase-appropriate analytical plans for new programs, process changes, and commercialization activities.
• Provide QC leadership for investigations involving OOS, OOT, non-conforming results.
• Establish and monitor quality and operational performance expectations for external testing partners through governance forums, metrics, trend reviews, and business process oversight.
• Author, review, and approve QC-related controlled documents, including specifications, protocols, reports, SOPs, method transfer plans, stability documents, and technical assessments as applicable.
• Build fit-for-purpose QC systems, governance, and internal capabilities appropriate for a virtual biotech environment, with a focus on compliance, technical rigor, and scalability.
• 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).

Senior Director, Global Quality Control

QA Engineer

• Lead the US Quality Assurance function for external GxP biologics operations, including oversight of CMOs, contract laboratories, and other critical service providers.
• Provide QA oversight for external manufacturing, testing, release support, deviations, investigations, CAPAs, change controls, product impact assessments, and disposition-related decisions.
• Design and maintain a robust, scalable product disposition program for clinical trial material as well as commercial products across multiple markets.
• Ensure continuous inspection readiness across outsourced operations and support health authority inspections, partner inspections, and due diligence activities.
• Monitor partner quality performance through defined metrics, scorecards, and governance forums; identify trends and proactively escalate compliance or execution risks.
• Partner cross-functionally to assess quality risk associated with process changes, deviations, investigations, comparability activities, tech transfer, and supply continuity issues.
• Provide strategic guidance on quality requirements for product lifecycle activities, including clinical supply, commercial readiness, distribution, complaints, and post-approval changes.
• Build and develop internal QA capabilities, processes, and team structure appropriate for a virtual biotech operating model.
• Drive a culture of quality, accountability, and proactive issue identification across internal stakeholders and external partners.
• 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).

Senior Director, US Quality Assurance

• Lead process development projects
• Collaborate with cross-functional teams
• Oversee upstream manufacturing operations
• Drive continuous improvement initiatives

Director, Upstream MSAT – Process Development

• Develop and execute manufacturing strategies to support drug product manufacturing needs.
• Lead end-to-end management of external drug product manufacturing, including planning, production, and delivery as well as execution of new projects.
• Interface closely with each drug product CMO as the Scholar Rock primary contact, providing direction to and partnering with the CMO program manager, site leadership and business lead as appropriate.
• Ensure CMOs meet production timelines, cost targets, and regulatory and quality standards.
• Establish and manage partnerships with CMOs to ensure capacity, capability, and compliance with company standards (e.g., FDA, EMA, ICH guidelines).
• Coordinate and manage CMO governance meetings, in partnership with CMO program manager and/or business lead.
• Maintain financial responsibility for CMO spend, managing the budget allocation, negotiating work statements, ensuring purchase requisitions are raised, and PO’s are reconciled.
• Establish alignment of objectives and priorities in close coordination with CMC team, supply chain, quality, regulatory CMC, and other functions as needed, representing the CMO(s) in strategic decisions.
• Drive continuous improvement initiatives across external manufacturing operations to optimize efficiency and cost-effectiveness.
• Partner with quality teams to address deviations, CAPAs, and other quality-related issues.
• Oversee CMO due diligence during new CMO selection to vet capabilities, risks and investments required.
• Engage, as needed, in contract negotiation and review. After execution of a contract, act as contract monitor, ensuring both Scholar Rock and the CMO comply with commitments.

Senior Director, Drug Product External Manufacturing

• Manage a timely closing process
• Compile month-end financial schedules for both internal and external audiences
• Manage accounts payable team
• Manage Concur platform for expense reporting
• Establish and document accounting procedures
• Perform account analyses
• Assist with 10-Q, 10-K filings
• Support ad-hoc projects as needed

Senior Accounting Manager

Marketing

• Lead the development of the U.S. HCP brand strategy for apitegromab, grounded in deep understanding of the SMA landscape, unmet need, and clinical data.
• Own U.S. HCP launch planning, including positioning, messaging, segmentation, targeting, and channel strategy.
• Translate strategy into high-quality, compliant HCP promotional tactics across personal and non-personal channels.
• Partner with Sales leadership to ensure strong integration between HCP marketing strategy and field execution.
• Oversee agency partners and vendors to deliver best-in-class creative and execution.
• Serve as a core member of the U.S. Marketing Team, collaborating closely with Medical Affairs, Market Access, Patient Services, Regulatory, Legal, and Compliance.
• Ensure HCP strategy is aligned with scientific narrative, access considerations, and patient support offerings.
• Provide strategic input into competitive readiness and scenario planning for current and future competitors as well as pipeline considerations.
• Leverage market research, customer insights, and performance data to inform strategy and optimize execution.
• Define key performance indicators and support development of dashboards to track launch performance and drive continuous improvement.
• Partner with ex-U.S. colleagues to share U.S. HCP strategy, learnings, and best practices.

Senior Director, HCP Marketing

• Lead the development of the U.S. patient and caregiver brand strategy for apitegromab, grounded in a deep understanding of the SMA community, patient journey, and unmet needs.
• Own U.S. patient launch planning, including strategy, messaging, channel mix, and executional roadmap.
• Translate strategy into high-quality, compliant patient-facing tactics across digital, community, advocacy-aligned, and experiential channels.
• Ensure consistency and excellence across all patient touchpoints while maintaining a strong, authentic patient-centric lens.
• Build and maintain strong, trusted relationships within the SMA patient and caregiver community.
• Lead the patient ambassador and engagement programs, including long-term retention and stewardship strategies.
• Own the U.S. patient conference and event strategy, elevating Scholar Rock’s presence and impact at key national, regional, and local meetings.
• Champion innovation in patient engagement, continuously evolving approaches to improve the patient experience across the journey.
• Serve as a core member of the U.S. Marketing Team, partnering closely with Patient Services, Medical Affairs, Advocacy, Market Access, Regulatory, Legal, and Compliance.
• Ensure strong alignment between patient marketing initiatives and patient support programs, including development of branded patient materials.

Senior Director, Patient Marketing

• Develop and own the U.S. KOL engagement strategy and annual engagement plan, aligned with brand strategy, medical priorities, and launch objectives.
• Identify, segment, and prioritize KOLs across key specialties and practice settings relevant to SMA.
• Establish clear objectives, success metrics, and engagement principles to guide compliant, meaningful KOL interactions.
• Lead the planning and execution of KOL engagement tactics, including peer-to-peer programming, advisory boards, congress engagement, and innovative engagement formats.
• Ensure excellence in program design, execution, and follow-up, with a strong focus on insight capture and learning.
• Partner closely with Medical Affairs to ensure alignment on scientific exchange, insight generation, and appropriate roles and responsibilities.
• Collaborate with Marketing and Sales to align KOL engagement with brand strategy and field needs, while maintaining clear compliance boundaries.
• Work with Field teams to support coordinated, high-quality KOL interactions at the regional and local level.
• Capture, synthesize, and share insights from KOL engagements to inform brand strategy, launch readiness, and ongoing optimization.
• Ensure all KOL engagement activities are conducted in full alignment with regulatory, legal, and compliance requirements.