Scholar Rock jobs - 20 jobs

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 Medical Director, reporting to the VP, Clinical Research, will be a member of the early development team, accountable for driving clinical development activities for product candidates from IND through Proof-of-Concept. The successful candidate will be responsible for providing medical leadership for clinical development activities of follow-on indication(s) for apitegromab as well as new product candidates, in alignment with corporate strategy. This position requires a highly motivated physician scientist with hands-on expertise in advancing product candidates to deliver life-changing medicines.Position Responsibilities: Deliver clinical development plan for assigned pipeline products from IND through Proof-of-Concept Provide medical leadership for clinical development activities of pipeline product candidates, including new indication assessment 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 Drive scientifically robust evaluation of new opportunities, including disease area assessment, landscape analysis, evaluation of development and regulatory pathways, and development of study concepts Provide strategic guidance and support to the early development team, including hands-on authoring, for the development 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 Candidate Requirements: MD, MD/PhD, or equivalent, based in greater Boston Strong critical thinking skills, with ability to synthesize complex information, and exceptional communication skills, both verbal and written 5+ years of experience in the biopharmaceutical clinical development function, with 3+ years of clinical development leadership experience; neuromuscular or rare disease experience preferred but not required Highly organized, outcome-oriented, self-motivated team player with strong interpersonal skills and effective conflict management skills Experience in innovative clinical study design, analysis of clinical data, publications, and working knowledge of biostatistics and pharmacokinetics/pharmacodynamics Understanding of the drug development process from pre-IND through BLA Experience interacting with health authorities in the US and EU In-depth knowledge of ICH-GCP and other application regulatory guidelines Ability to travel domestically and internationally (~15%) Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

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: Scholar Rock is seeking a Program Leader, Next Wave to serve as a Program Leader (PL) for our emerging portfolio of programs to address rare, neuromuscular diseases. This individual will act as the key point of contact for early-stage or "next wave" assets and drive these programs through critical developmental transition points. This utility player must possess an entrepreneurial spirit and an enterprise mindset, capable of bridging the gap between scientific discovery, clinical reality, and commercial landscape. You will lead cross-functional teams, define the integrated development strategy, and ensure the successful delivery of projects within scope, time, and budget. You will work in a fast-paced dynamic environment with a sense of urgency, acting as a primary driver of value creation for the company's future.This position reports to the Head of Program Leadership and Management. Position Responsibilities: Strategic Program Leadership Serve as the Program Leader (PL) for assigned pipeline assets, holding accountability for the development and execution of the Integrated Development Plan (IDP), consisting of overall project timeline to regulatory approval Drive assets through major inflection points (e.g., advancing program to development, IND enablement, Clinical Phase 1 to 2 transitions). Lead the cross-functional Program Team (PT), facilitating high-quality decision-making and ensuring alignment across cross-functional partners and integrating across Research & Development Lead the definition and maintenance of the Target Product Profile (TPP), in collaboration with cross-functional partners End-to-End Process & Risk Management Apply a strong understanding of end-to-end drug development, process management, and organizational interdependencies to anticipate challenges before they become critical path blockers and partner with the team to develop mitigation strategies Proactively identify, articulate, escalate, and manage program risks; collaborate with key stakeholders to recommend constructive solutions rather than just reporting on status. Communication & Enterprise Leadership Act as the central communication hub, ensuring effective and timely communication to team members and senior leadership regarding program status, key milestones, and strategic pivots. Foster a culture of collaboration and accountability, resolving conflicts within the team and ensuring all functions are moving in lockstep. Candidate Requirements: Advanced degree preferred (e.g., PhD, PharmD, or MBA); real-world experience in life sciences is required The ideal candidate will have prior experience working on pre-clinical or clinical stage programs in either neurology or neuromuscular diseases. The ideal candidate will have direct, hands-on experience on drug development in a clinical stage program across either clinical research, biostatistics, or regulatory affairs Proven track record of moving a clinical-stage molecule through a major inflection point or interface (e.g., Research to Development, Clinical Phase 1 to 2, or Clinical to Commercial) Skills & Capabilities: Utility Player: Demonstrated ability to flex between high-level strategy and hands-on execution with an entrepreneurial spirit. End-to-End Fluency: Strong understanding of the drug development lifecycle, from discovery target validation through to commercial launch. Leadership: Exceptional communication and interpersonal skills with the ability to lead without authority and influence stakeholders across the organization. Operational Excellence: Extremely well-organized with the ability to manage multiple programs and drive clarity in complex, ambiguous situations Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

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: Scholar Rock is seeking a motivated, energetic, and outstanding individual with experience in clinical pharmacology and pharmacometrics to join our team in developing novel biologic therapies that target protein growth factors in the disease microenvironment. The Director/Senior Director of Clinical Pharmacology, reporting to the Head of Clinical Pharmacology, will have strong quantitative clinical pharmacology skills and hands-on modeling and simulation experience. This individual will be responsible for the analysis and interpretation of PK, PD, and efficacy data to guide the development of biologics including monoclonal antibodies. The ideal candidate will have significant experience in subcutaneous drug development. Position Responsibilities: Lead clinical pharmacology strategies across multiple programs at various stages of clinical development Execute modeling and simulation plans including PK/PD, population PK, and exposure-response analyses to guide clinical trial design, dose selection and optimization Develop clinical pharmacology plans to bridge IV to SC dosing Provide pediatric clinical pharmacology expertise and co-lead workstreams related to formulation development and sub-cutaneous route of administration Apply model-based drug development principles to answer key development questions enabling efficient drug development Contribute to preparation of regulatory documents and participate in discussions with Regulatory Agencies, with a focus on Model-informed Drug Development (MIDD). Contribute to clinical protocol design, study execution, data analysis, and writing clinical study reports Collaborate and mentor bioanalytical and translational team to develop comprehensive preclinical and clinical PK/PD strategy Candidate Requirements: PhD in pharmacokinetics or pharmacology 7-10 years of experience in pharma/biotech industry, with proven track record of using clinical pharmacology to guide clinical trial/dosing decision Proficient knowledge and hands-on experience in all aspects of clinical pharmacology, including modeling and simulation of pharmacokinetic, pharmacodynamic, and efficacy relationships, including expertise with population modeling Ability to interpret and integrate complex data sets across multiple disciplines including pharmacology, DMPK, toxicology assessing the clinical relevance Experience in subcutaneous drug development and IV to SC bridging is highly desired Strong interpersonal skills to work effectively in a team setting/matrix-type organization Understands the drug development process from pre-IND through BLA Highly organized, outcome-oriented, self-motivated performer Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

Job Description 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: Scholar Rock is entering a transformative phase with its first global commercial launch underway and a pipeline of biologics advancing through clinical development. We are seeking a strategic, execution-oriented Head of Global GxP Quality to lead our Quality organization across both commercial and clinical operations. Reporting to the Chief Technical & Quality Officer (CTO/CQO), this role will be accountable for building and leading a global, integrated GxP Quality function, spanning GMP, GDP, GCP, GLP, Quality Systems, Quality Control, EU Quality, and post-market surveillance. This is a mission-critical leadership role responsible for ensuring regulatory compliance, global inspection readiness, and operational excellence across the product lifecycle. Scholar Rock is advancing life-changing therapies rooted in biologics and deep science. With our first commercial product approaching launch and a pipeline of promising assets, we are building for the long term. This role offers a rare opportunity to lead and shape a global Quality function at one of the most critical and exciting moments in our growth trajectory.Position Responsibilities: Strategic Leadership: Develop and execute Scholar Rock's global GxP Quality strategy across clinical and commercial programs, ensuring alignment with global regulatory expectations (FDA, EMA, ICH). Serve as the executive Quality representative for regulatory inspections (e.g., FDA PAI, EMA MAA) and major health authority interactions. Collaborate cross-functionally with Manufacturing, Supply Chain, Regulatory, and Clinical leaders to embed Quality into end-to-end business processes. Quality Functional Oversight: GMP Quality Assurance: Oversee DS, DP, and finished goods quality across internal operations and external CDMOs; ensure compliant batch disposition and vendor oversight. R&D Quality (GCP/GLP): Lead quality oversight across Scholar Rock's clinical and nonclinical development programs. This includes GCP compliance, CRO/vendor qualification, clinical site audits, TMF management, inspection readiness, and GLP oversight for IND-enabling studies. EU Quality & QP Oversight: Ensure compliance with EU GDP/importation requirements and maintain oversight of QP batch certification and market release processes. Quality Control (QC): Provide strategic oversight for release and stability testing, method validation/transfer, reference standards, and specification lifecycle management. Quality Management Systems (QMS): Own and evolve the global QMS, including deviation/CAPA management, change control, documentation, training, and internal/external audit programs. Post-Market Surveillance: Establish and oversee global processes for product quality complaints, field alert reporting, investigation closure, and compliance with post-market reporting requirements. Team Leadership & Governance: Build and lead a high-performing global Quality organization, ensuring technical excellence, regulatory compliance, and a culture of accountability and transparency. Define and monitor Quality performance metrics, implement continuous improvement initiatives, and ensure systems readiness for global scale. Represent Quality in executive governance forums, regulatory planning, and launch readiness reviews. Candidate Requirements: 15+ years of progressive leadership in biopharmaceutical Quality, including experience supporting global commercial launches and late-stage clinical development. Deep expertise across GMP, GCP, GLP, GDP, and Quality Systems, with a track record of successfully leading organizations through regulatory inspections (FDA, EMA, etc.). Demonstrated success managing external partners (CDMOs, CROs, testing labs) in a virtual or hybrid operating model. Strong understanding of regulatory expectations for global post-market quality systems, including complaint management and field alert reporting. Proven ability to scale Quality organizations and systems to support commercial expansion and global operations. Excellent communication, leadership presence, and cross-functional collaboration skills. Bachelor's degree in life sciences or related field required; advanced degree preferred. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

We are seeking a dynamic and strategic Associate Director, Regulatory Affairs to join our Regulatory Affairs team. The Associate Director of Regulatory Affairs leads the development and execution of global regulatory strategies to support the approval and lifecycle management of pharmaceutical products. This role partners cross-functionally with R&D, Clinical, Quality, and Commercial teams to ensure regulatory alignment with business objectives and compliance with global health authority requirements. The Associate Director provides expert guidance on regulatory pathways, risk assessment, and submission strategies. Key Responsibilities Regulatory Strategy (50%) Develop regulatory strategies for clinical development programs (which may range from FIH through post-marketing stage. Provide solid regulatory solutions and guidance to the cross-functional teams and senior management. Provide tactical support and operational expertise with “hands on” support as needed. Project Management (25%) Assess project plans and timelines. Work collaboratively to ensure all projects are appropriately prioritized and key goals are met on time. Regulatory Compliance (25%) Ensure compliance of regulatory strategies and submissions. Oversee preparation and review of regulatory submissions and responses. Monitor regulatory trends and ensure proactive strategy adjustments. Other duties and responsibilities as assigned. Qualifications Required Qualifications B.S/M.S. and 10+ years of work experience in pharmaceutical regulatory affairs 5+ years of regulatory experience working with global development and submission plans Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to oncology drug development in the US and EU Must have experience filing INDs and NDAs and engagement with FDA and other regulatory bodies Preferred Experience Capable of strategic thinking and proposing innovative solutions to regulatory problems Demonstrates excellent verbal and written communication skills Experience managing a regulatory team member Additional Information Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $162,200 - $223,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location. Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable) Benefits: Competitive salary and annual bonus. Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. Generous parental leave and family planning benefits. Outstanding culture and opportunities for personal and professional growth. Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team! EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis. EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

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: In this role, you will be responsible for a wide variety of projects across the Commercial organization to include, but not limited to, functioning as the business lead for sales sizing and alignment, field incentive compensation design and implementation, field analytics and reporting, implementation of commercial systems, collaboration with brand marketing/e-marketing initiatives and supporting KPIs for overall performance. Additionally, you will identify critical business issues and opportunities for growth, collaborate with cross-functional teams, and work to embed an external market point-of-view into the strategic direction of the company.Position Responsibilities: Strategic Leadership & Operational Excellence Define and implement a structured framework of goals and tactics to build a best-in-class Field and Sales Operations organization. Establish and maintain robust analytics and operational processes that effectively support the General Managers and Sales organization. Data Governance & Systems Integration Serve on a cross-functional data governance team to define business rules and processes that ensure data integrity and consistency. Partner with Sales and IT to design, deploy and maintain Veeva both in the US and ROW Provide Field Operation Support for ROW Ensure organizational compliance with CRM data standards and quality protocols. Sales Enablement & Field Optimization Train the commercial field sales team on systems, tools, and processes to maximize efficiency and adoption. Develop and refine field sizing and deployment strategies to optimize sales force effectiveness and meet business objectives. Manage territory alignment and roster systems to ensure optimal resource utilization. Manages the field sales force credentialling program Performance Management & Incentives Lead the development and execution of incentive compensation programs aligned with strategic goals, including plan design, governance, goal setting, reporting, and payout processing. Monitor departmental performance against KPIs and collaborate with commercial leadership to drive continuous improvement. Cross-Functional Collaboration & Commercial Readiness Oversee and execute a broad range of commercial initiatives to ensure organizational readiness for product launches. Collaborate across the Commercial team to align operational strategies with key business objectives and priorities. Candidate Requirements: Bachelor's degree in business, science or related field. A master's degree (MBA) strongly preferred. 8-10 years of experience working in the pharmaceutical or biotech industry with five plus years supporting field sales teams. Extensive experience supporting technical design of commercial systems. Implementation experience a must. Extensive experience with Veeva CRM, data management and incentive compensation Experience with Symphony, IQVIA. CROSSIX and related pharmaceutical sales data Experience working with field sales teams, field reporting and incentive compensation Strong analytical skills with the capability to appropriately define issues, questions and data; to comprehend quantitative methods and analytical techniques; to perform accurate analysis (correctly calculated numbers, accurate graphs); to cross-check data and assumptions; to document and establish data trails; and to think creatively about different ways to analyze data and information Excellent quantitative background that supports the analysis of data to better understand market dynamics and provide insights into product performance and marketing strategy. Strong interpersonal skills with demonstrated ability to drive toward consensus. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

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 Chief Information Officer (CIO)/VP of IT will lead Scholar Rock's global IT function through a period of rapid growth, modernization, and strategic transformation. This executive will ensure workplace enablement and IT service reliability today, while defining and executing a forward-looking technology vision that enables global commercialization, compliant operations, and digital innovation. A proven builder and scaler of IT organizations and systems, the CIO/VP IT will establish the people, processes, and platforms needed to support Scholar Rock's growth from a development-stage biotech to a fully integrated global commercial company. The CIO/VP IT will also be a visible leader with regular engagement at the Executive Team and Board level, providing updates on IT performance, cybersecurity, compliance, and digital strategy.Position Responsibilities: Workplace Enablement & Operational Excellence: 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. Strategic IT & Technology Enablement: 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. GxP, Commercial & G&A Systems: 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 to integrate patient services, market access, sales, and medical data. 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, reporting, and global operations. HRIS/HCM platforms to support workforce growth, talent management, and global mobility. Procurement, contracts, and compliance tools for a public company environment. Cybersecurity & Global Infrastructure: 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. IT Organization Build & Resourcing: 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. Candidate Qualifications: 15+ years of IT leadership, including senior executive experience in biotech, pharma, or life sciences. Required: Demonstrated success building and scaling IT organizations and enterprise systems to support global business growth. Proven track record in stabilizing IT operations while delivering long-term digital strategy. Deep knowledge of GxP IT systems, validation, and global regulatory requirements. Experience implementing and managing commercial IT platforms (CRM, data hub, analytics, field force tools). Experience leading Finance (ERP) and HRIS/HCM systems implementation and optimization in a public company context. Strong background in data strategy, digital innovation, and technology enablement. Excellent leadership, vendor management, and change management skills. Strong boardroom presence, with experience preparing and delivering executive and board-level updates. Personal Attributes: Visionary leader who can inspire through technology enablement while solving immediate operational challenges. Pragmatic and hands-on, with a strong bias for action and accountability. Collaborative, enterprise-minded, and skilled at influencing across a global matrix. Confident communicator with the executive presence to engage regularly with the Board and senior leadership. Excited by the challenge of building technology capabilities that empower employees and accelerate global impact. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

Job Description 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: Scholar Rock is seeking a highly experienced and technically strong Senior Director of Drug Product Development to lead formulation and drug product development efforts across our portfolio of biologics, including monoclonal antibodies, fusion proteins, and bispecifics. This role will be responsible for driving drug product strategy and execution across modalities and presentations-from intravenous (IV) to subcutaneous (SubQ), including high-concentration formulations, prefilled syringes (PFS), and autoinjectors (AI). The ideal candidate brings extensive experience in setting strategic direction and hands-on leadership of formulation development, process development, tech transfer, and commercial readiness for biologic combination products. This position requires a deep understanding of technical and regulatory aspects of combination product development, including drug product formulation and fill/finish process, primary container development, stability.Position Responsibilities: Lead end-to-end drug product development for Scholar Rock's biologic assets across all phases-from preclinical development through commercialization. Define and execute robust formulation strategies to support both IV and SubQ presentations, including development of high-concentration (≥200 mg/mL), stable formulations. Lead the development and optimization of vial and of the target combination product presentation (pre-filled syringe / autoinjector). Collaborate with internal and external resources to achieve a combination product presentation suitable for patient use. Provide scientific leadership in evaluating excipients, container closure compatibility, viscosity, and stability to support target product profiles and patient-centric delivery. Drive selection and integration of drug delivery devices (e.g., PFS/AI) in collaboration with commercial, clinical, and regulatory functions. Establish phase-appropriate formulation control strategies and support setting and justification of specifications in coordination with Analytical Development. Direct process development activities including fill-finish process design, container closure system evaluation, and scale-up for clinical and commercial manufacturing. Lead technical due diligence, selection, and oversight of CDMOs and technical support for drug product manufacturing. Ensure successful tech transfers, manufacturing readiness, and PPQ strategy development in collaboration with Manufacturing and Quality. Apply Quality by Design (QbD) principles to develop and optimize robust drug product formulations and processes. Partner closely with Analytical Development to define and maintain specifications and support real-time release strategies. Act as the technical lead for DP-related CMC sections of regulatory submissions (INDs, BLAs, IMPDs), including response to health authority questions and engage with regulatory agencies (FDA, EMA, PMDA) to support development, inspection readiness and support. Represent Drug Product function on cross-functional CMC and program teams. Foster a culture of scientific rigor, innovation, collaboration, and continuous improvement. Candidate Requirements: Ph.D. in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, or related field with 12+ years (or M.S. with 15+ years) of experience in biologics drug product development with emphasis on high concentration biologic formulation for combination product development, particularly with pre-filled syringes and autoinjectors. Deep expertise in formulation development for monoclonal antibodies and other complex biologics, including high-concentration SubQ products. Proven track record in advancing injectable drug products from early development through commercialization including demonstrated success in managing late-stage process validation studies. Experience leading workstreams for PFS/AI combination products, including primary container evaluation, combination product platform technology evaluation, design control process, design verification studies and validation, human factors engineering, and regulatory expectations. Strong technical leadership, project management, and cross-functional collaboration skills. Familiarity with regulatory expectations for DP development and CMC submissions in US and EU. Preferred Experience: Experience with combination products, device development, and cold-chain distribution. Prior leadership of external CDMO partnerships. Experience with QbD-based development and global CMC strategy implementation. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

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: Scholar Rock is entering a transformative phase with its first global commercial launch underway and a pipeline of biologics advancing through clinical development. We are seeking a strategic, execution-oriented Head of Global GxP Quality to lead our Quality organization across both commercial and clinical operations. Reporting to the Chief Technical & Quality Officer (CTO/CQO), this role will be accountable for building and leading a global, integrated GxP Quality function, spanning GMP, GDP, GCP, GLP, Quality Systems, Quality Control, EU Quality, and post-market surveillance. This is a mission-critical leadership role responsible for ensuring regulatory compliance, global inspection readiness, and operational excellence across the product lifecycle. Scholar Rock is advancing life-changing therapies rooted in biologics and deep science. With our first commercial product approaching launch and a pipeline of promising assets, we are building for the long term. This role offers a rare opportunity to lead and shape a global Quality function at one of the most critical and exciting moments in our growth trajectory.Position Responsibilities: Strategic Leadership: Develop and execute Scholar Rock's global GxP Quality strategy across clinical and commercial programs, ensuring alignment with global regulatory expectations (FDA, EMA, ICH). Serve as the executive Quality representative for regulatory inspections (e.g., FDA PAI, EMA MAA) and major health authority interactions. Collaborate cross-functionally with Manufacturing, Supply Chain, Regulatory, and Clinical leaders to embed Quality into end-to-end business processes. Quality Functional Oversight: GMP Quality Assurance: Oversee DS, DP, and finished goods quality across internal operations and external CDMOs; ensure compliant batch disposition and vendor oversight. R&D Quality (GCP/GLP): Lead quality oversight across Scholar Rock's clinical and nonclinical development programs. This includes GCP compliance, CRO/vendor qualification, clinical site audits, TMF management, inspection readiness, and GLP oversight for IND-enabling studies. EU Quality & QP Oversight: Ensure compliance with EU GDP/importation requirements and maintain oversight of QP batch certification and market release processes. Quality Control (QC): Provide strategic oversight for release and stability testing, method validation/transfer, reference standards, and specification lifecycle management. Quality Management Systems (QMS): Own and evolve the global QMS, including deviation/CAPA management, change control, documentation, training, and internal/external audit programs. Post-Market Surveillance: Establish and oversee global processes for product quality complaints, field alert reporting, investigation closure, and compliance with post-market reporting requirements. Team Leadership & Governance: Build and lead a high-performing global Quality organization, ensuring technical excellence, regulatory compliance, and a culture of accountability and transparency. Define and monitor Quality performance metrics, implement continuous improvement initiatives, and ensure systems readiness for global scale. Represent Quality in executive governance forums, regulatory planning, and launch readiness reviews. Candidate Requirements: 15+ years of progressive leadership in biopharmaceutical Quality, including experience supporting global commercial launches and late-stage clinical development. Deep expertise across GMP, GCP, GLP, GDP, and Quality Systems, with a track record of successfully leading organizations through regulatory inspections (FDA, EMA, etc.). Demonstrated success managing external partners (CDMOs, CROs, testing labs) in a virtual or hybrid operating model. Strong understanding of regulatory expectations for global post-market quality systems, including complaint management and field alert reporting. Proven ability to scale Quality organizations and systems to support commercial expansion and global operations. Excellent communication, leadership presence, and cross-functional collaboration skills. Bachelor's degree in life sciences or related field required; advanced degree preferred. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

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: Scholar Rock is seeking a highly experienced and organized leader to provide global CMC leadership across our portfolio of biologics, including monoclonal antibodies, fusion proteins, and bispecifics. As the Director, CMC Management, you will be accountable for CMC project and portfolio management activities for our products working closely with CMC technical leads and cross-functional CMC teams. This role will require attention to detail, proficiency in forward planning and organizational skills and effective stakeholder management to ensure seamless development of CMC plans for clinical and commercial programs.Position Responsibilities: Provide leadership to develop and maintain integrated CMC development plans across our candidate programs and pro-actively identify critical path activities for key program milestones to allow for a focused and successful CMC workflow for all programs Collaborate cross-functionally to effectively monitor progress and drive CMC activities and ensure alignment with overall program goals and timelines Track program risks, proactively identifying and resolving issues, and working cross-functionally to develop contingency plans to ensure program success Support development and refinement of processes, tools, and systems to deliver high quality project management for the CMC programs Develop and maintain dashboards and organize and maintain documentation for CMC plans for each program Support Regulatory CMC with submission timelines e.g. reviews, approvals within CMC functional areas Champion a winning culture, fostering teamwork and commitment to excellence through transparent communication, engagement and collaboration Develop global CMC strategy in collaboration with CMC leads and functional teams; Proactively identify issues and drive resolution; anticipating key future events and adjusting team priorities/plans accordingly to deliver high quality results on time. Candidate Requirements: Bachelor's Degree in Science or related field, or equivalent with 12 years of related work experience, or advanced degree and a minimum of 8 years of work experience 8+ years of experience with biologics CMC early-stage, late-stage, and lifecycle management projects Experience in achieving CMC objectives through an outsourced CDMO model Excellent communication and interpersonal skills with the ability to influence and gain consensus across multiple functions, manage a diverse set of stakeholders, and work closely with team leaders Strong analytical, problem solving and critical thinking skills; highly organized. Proven track record of successful project management of complex drug development programs in a fast-paced environment Project and portfolio management certificate or expertise; expertise with project management tools (e.g. Smartsheet, MS Project, dashboards) Ability to manage multiple workstreams simultaneously and prioritize effectively in a fast-paced environment Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

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: Scholar Rock is seeking a strategic and accomplished scientific leader to serve as Head of Biomarker Development. This individual will be responsible for shaping and executing the biomarker strategy across Scholar Rock's pipeline to enable translation from discovery through clinical development in neuromuscular and rare diseases. Reporting to the Vice President, Head of Preclinical Sciences, this leader will design and implement fit-for-purpose biomarker approaches, oversee assay development and data generation, and serve as a key contributor to regulatory submissions, clinical protocols, and program strategy. This individual will be a member of the research leadership team. The successful candidate will integrate discovery, translational, and clinical perspectives to ensure biomarker strategies inform patient selection, target engagement, pharmacodynamics, and disease progression across stages of development. Position Responsibilities:Strategic Leadership & Vision Define and drive the biomarker development strategy across preclinical and clinical programs, ensuring alignment with overall portfolio goals. Serve as a translational science thought leader, integrating biomarker approaches into program strategy, clinical development plans, and indication expansion activities. Represent Biomarker Development in cross-functional governance and portfolio planning forums. Functional & Scientific Oversight Lead the design, development, and qualification of fit-for-purpose biomarker assays (fluid, tissue, imaging, molecular, and cellular). Oversee biomarker implementation in preclinical models and clinical studies, ensuring robust data generation and interpretation. Manage CROs and external collaborators/vendors to deliver high-quality biomarker data. Collaborate with discovery teams to translate preclinical biomarker hypotheses into clinically actionable endpoints. Provide expertise on novel technologies (e.g., immunoassays, LC-MS, SIMOA, RNA-seq, digital pathology, imaging biomarkers, multiparameter flow cytometry). Regulatory & Clinical Integration Contribute to the design of biomarker plans within clinical study protocols, informed consent forms, and statistical analysis plans. Author and review biomarker sections of INDs, CTAs, IBs, CSRs, and other regulatory filings. Present biomarker data and strategy to internal stakeholders, governance committees, external partners, and regulatory agencies. Candidate Requirements: PhD in biology, immunology, neuroscience, pharmacology, or related discipline. 10+ years of experience in biotech/pharma R&D with a strong track record in biomarker discovery and development, including translational application in clinical trials. Demonstrated leadership in developing and implementing biomarker strategies for rare diseases; experience in neuromuscular disorders strongly preferred. Proven expertise with a range of biomarker platforms (immunoassays, LC-MS, transcriptomics, imaging, flow cytometry, digital pathology, and molecular assays). Familiarity with bioanalytical and regulatory requirements for biomarker integration in IND-enabling studies and clinical development. Experience managing CROs, external consultants, and collaborative teams. Strong leadership, interpersonal, and communication skills, with the ability to influence across levels and functions. Passion for rare disease research and a commitment to improving patients' lives. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

Job Description 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 Medical Director, reporting to the VP, Clinical Research, will be a member of the early development team, accountable for driving clinical development activities for product candidates from IND through Proof-of-Concept. The successful candidate will be responsible for providing medical leadership for clinical development activities of follow-on indication(s) for apitegromab as well as new product candidates, in alignment with corporate strategy. This position requires a highly motivated physician scientist with hands-on expertise in advancing product candidates to deliver life-changing medicines.Position Responsibilities: Deliver clinical development plan for assigned pipeline products from IND through Proof-of-Concept Provide medical leadership for clinical development activities of pipeline product candidates, including new indication assessment 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 Drive scientifically robust evaluation of new opportunities, including disease area assessment, landscape analysis, evaluation of development and regulatory pathways, and development of study concepts Provide strategic guidance and support to the early development team, including hands-on authoring, for the development 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 Candidate Requirements: MD, MD/PhD, or equivalent, based in greater Boston Strong critical thinking skills, with ability to synthesize complex information, and exceptional communication skills, both verbal and written 5+ years of experience in the biopharmaceutical clinical development function, with 3+ years of clinical development leadership experience; neuromuscular or rare disease experience preferred but not required Highly organized, outcome-oriented, self-motivated team player with strong interpersonal skills and effective conflict management skills Experience in innovative clinical study design, analysis of clinical data, publications, and working knowledge of biostatistics and pharmacokinetics/pharmacodynamics Understanding of the drug development process from pre-IND through BLA Experience interacting with health authorities in the US and EU In-depth knowledge of ICH-GCP and other application regulatory guidelines Ability to travel domestically and internationally (~15%) Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

Job Description 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 Chief Information Officer (CIO)/VP of IT will lead Scholar Rock's global IT function through a period of rapid growth, modernization, and strategic transformation. This executive will ensure workplace enablement and IT service reliability today, while defining and executing a forward-looking technology vision that enables global commercialization, compliant operations, and digital innovation. A proven builder and scaler of IT organizations and systems, the CIO/VP IT will establish the people, processes, and platforms needed to support Scholar Rock's growth from a development-stage biotech to a fully integrated global commercial company. The CIO/VP IT will also be a visible leader with regular engagement at the Executive Team and Board level, providing updates on IT performance, cybersecurity, compliance, and digital strategy.Position Responsibilities: Workplace Enablement & Operational Excellence: 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. Strategic IT & Technology Enablement: 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. GxP, Commercial & G&A Systems: 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 to integrate patient services, market access, sales, and medical data. 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, reporting, and global operations. HRIS/HCM platforms to support workforce growth, talent management, and global mobility. Procurement, contracts, and compliance tools for a public company environment. Cybersecurity & Global Infrastructure: 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. IT Organization Build & Resourcing: 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. Candidate Qualifications: 15+ years of IT leadership, including senior executive experience in biotech, pharma, or life sciences. Required: Demonstrated success building and scaling IT organizations and enterprise systems to support global business growth. Proven track record in stabilizing IT operations while delivering long-term digital strategy. Deep knowledge of GxP IT systems, validation, and global regulatory requirements. Experience implementing and managing commercial IT platforms (CRM, data hub, analytics, field force tools). Experience leading Finance (ERP) and HRIS/HCM systems implementation and optimization in a public company context. Strong background in data strategy, digital innovation, and technology enablement. Excellent leadership, vendor management, and change management skills. Strong boardroom presence, with experience preparing and delivering executive and board-level updates. Personal Attributes: Visionary leader who can inspire through technology enablement while solving immediate operational challenges. Pragmatic and hands-on, with a strong bias for action and accountability. Collaborative, enterprise-minded, and skilled at influencing across a global matrix. Confident communicator with the executive presence to engage regularly with the Board and senior leadership. Excited by the challenge of building technology capabilities that empower employees and accelerate global impact. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

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: Scholar Rock is seeking an experienced and motivated Director/Senior Director of Pharmacoepidemiology. Reporting to the Head of Drug Safety & Pharmacovigilance, the incumbent will serve as the key subject matter expert within safety and on cross-functional Development and Submission Teams involving epidemiologic analyses. The individual will be the primary point of accountability for the development and oversight of post-authorization studies to fulfill Regulatory Commitments e.g., PMRs, PASS and PAES involving observational study data. Position Responsibilities: Designs, produces and oversees protocols for observational studies using secondary data or primary data collection, including Company-sponsored or other data sources Oversee timely and appropriate development of epidemiological sections of regulatory documents for agencies worldwide (e.g., Risk Management Plan, orphan or breakthrough designations, Pediatric Investigation Plan, query responses, advisory committee briefing documents Contributes to Risk Management Plans (RMP, PV Plans etc) for products throughout lifecycle Performs systematic epidemiologic literature reviews and summaries for relevant safety topics Performs signal detection analyses of safety reporting system databases (AERS, Vigibase) using data mining software Actively participates including making presentations at meetings including product safety team and Global Patient Safety staff meetings May supervise 3rd parties e.g., vendors or contract/other staff Supports PV System implementation and maintenance and other Departmental goals and objectives Candidate Requirements: Doctoral degree e.g., PhD or Master's degree in Epidemiology from an accredited institution Minimum of 10 years relevant work experience, preferentially in the Pharmaceutical/Biotechnology industry with a primary focus on epidemiology evidence generation, especially for clinical development support, regulatory submissions and safety Solid knowledge of study methodology in general medicine and clinical practice, evidenced by experience in designing/conducting epidemiology studies, including Registries Strong knowledge and experience in Global Pharmacovigilance guidelines, Risk Management and regulations; knowledge of international PV regulations is a plus Experience with data mining software and applications Demonstrated ability to function with a high level of autonomy and develop productive cross-functional collaborations. Ability to manage priorities, resources, and performance targets, in a changing environment. Ability to communicate proactively with others across functions to ensure shared purpose and clear accountability for future decisions. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

Job Description 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: Scholar Rock is seeking a highly experienced and organized leader to provide global CMC leadership across our portfolio of biologics, including monoclonal antibodies, fusion proteins, and bispecifics. As the Director, CMC Management, you will be accountable for CMC project and portfolio management activities for our products working closely with CMC technical leads and cross-functional CMC teams. This role will require attention to detail, proficiency in forward planning and organizational skills and effective stakeholder management to ensure seamless development of CMC plans for clinical and commercial programs.Position Responsibilities: Provide leadership to develop and maintain integrated CMC development plans across our candidate programs and pro-actively identify critical path activities for key program milestones to allow for a focused and successful CMC workflow for all programs Collaborate cross-functionally to effectively monitor progress and drive CMC activities and ensure alignment with overall program goals and timelines Track program risks, proactively identifying and resolving issues, and working cross-functionally to develop contingency plans to ensure program success Support development and refinement of processes, tools, and systems to deliver high quality project management for the CMC programs Develop and maintain dashboards and organize and maintain documentation for CMC plans for each program Support Regulatory CMC with submission timelines e.g. reviews, approvals within CMC functional areas Champion a winning culture, fostering teamwork and commitment to excellence through transparent communication, engagement and collaboration Develop global CMC strategy in collaboration with CMC leads and functional teams; Proactively identify issues and drive resolution; anticipating key future events and adjusting team priorities/plans accordingly to deliver high quality results on time. Candidate Requirements: Bachelor's Degree in Science or related field, or equivalent with 12 years of related work experience, or advanced degree and a minimum of 8 years of work experience 8+ years of experience with biologics CMC early-stage, late-stage, and lifecycle management projects Experience in achieving CMC objectives through an outsourced CDMO model Excellent communication and interpersonal skills with the ability to influence and gain consensus across multiple functions, manage a diverse set of stakeholders, and work closely with team leaders Strong analytical, problem solving and critical thinking skills; highly organized. Proven track record of successful project management of complex drug development programs in a fast-paced environment Project and portfolio management certificate or expertise; expertise with project management tools (e.g. Smartsheet, MS Project, dashboards) Ability to manage multiple workstreams simultaneously and prioritize effectively in a fast-paced environment Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

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: Scholar Rock is seeking a highly experienced and technically strong Senior Director of Drug Product Development to lead formulation and drug product development efforts across our portfolio of biologics, including monoclonal antibodies, fusion proteins, and bispecifics. This role will be responsible for driving drug product strategy and execution across modalities and presentations-from intravenous (IV) to subcutaneous (SubQ), including high-concentration formulations, prefilled syringes (PFS), and autoinjectors (AI). The ideal candidate brings extensive experience in setting strategic direction and hands-on leadership of formulation development, process development, tech transfer, and commercial readiness for biologic combination products. This position requires a deep understanding of technical and regulatory aspects of combination product development, including drug product formulation and fill/finish process, primary container development, stability.Position Responsibilities: Lead end-to-end drug product development for Scholar Rock's biologic assets across all phases-from preclinical development through commercialization. Define and execute robust formulation strategies to support both IV and SubQ presentations, including development of high-concentration (≥200 mg/mL), stable formulations. Lead the development and optimization of vial and of the target combination product presentation (pre-filled syringe / autoinjector). Collaborate with internal and external resources to achieve a combination product presentation suitable for patient use. Provide scientific leadership in evaluating excipients, container closure compatibility, viscosity, and stability to support target product profiles and patient-centric delivery. Drive selection and integration of drug delivery devices (e.g., PFS/AI) in collaboration with commercial, clinical, and regulatory functions. Establish phase-appropriate formulation control strategies and support setting and justification of specifications in coordination with Analytical Development. Direct process development activities including fill-finish process design, container closure system evaluation, and scale-up for clinical and commercial manufacturing. Lead technical due diligence, selection, and oversight of CDMOs and technical support for drug product manufacturing. Ensure successful tech transfers, manufacturing readiness, and PPQ strategy development in collaboration with Manufacturing and Quality. Apply Quality by Design (QbD) principles to develop and optimize robust drug product formulations and processes. Partner closely with Analytical Development to define and maintain specifications and support real-time release strategies. Act as the technical lead for DP-related CMC sections of regulatory submissions (INDs, BLAs, IMPDs), including response to health authority questions and engage with regulatory agencies (FDA, EMA, PMDA) to support development, inspection readiness and support. Represent Drug Product function on cross-functional CMC and program teams. Foster a culture of scientific rigor, innovation, collaboration, and continuous improvement. Candidate Requirements: Ph.D. in Pharmaceutics, Chemistry, Chemical/Biochemical Engineering, or related field with 12+ years (or M.S. with 15+ years) of experience in biologics drug product development with emphasis on high concentration biologic formulation for combination product development, particularly with pre-filled syringes and autoinjectors. Deep expertise in formulation development for monoclonal antibodies and other complex biologics, including high-concentration SubQ products. Proven track record in advancing injectable drug products from early development through commercialization including demonstrated success in managing late-stage process validation studies. Experience leading workstreams for PFS/AI combination products, including primary container evaluation, combination product platform technology evaluation, design control process, design verification studies and validation, human factors engineering, and regulatory expectations. Strong technical leadership, project management, and cross-functional collaboration skills. Familiarity with regulatory expectations for DP development and CMC submissions in US and EU. Preferred Experience: Experience with combination products, device development, and cold-chain distribution. Prior leadership of external CDMO partnerships. Experience with QbD-based development and global CMC strategy implementation. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

Job Description We are seeking a dynamic and strategic Associate Director, Regulatory Affairs to join our Regulatory Affairs team. The Associate Director of Regulatory Affairs leads the development and execution of global regulatory strategies to support the approval and lifecycle management of pharmaceutical products. This role partners cross-functionally with R&D, Clinical, Quality, and Commercial teams to ensure regulatory alignment with business objectives and compliance with global health authority requirements. The Associate Director provides expert guidance on regulatory pathways, risk assessment, and submission strategies. Key Responsibilities Regulatory Strategy (50%) Develop regulatory strategies for clinical development programs (which may range from FIH through post-marketing stage. Provide solid regulatory solutions and guidance to the cross-functional teams and senior management. Provide tactical support and operational expertise with “hands on” support as needed. Project Management (25%) Assess project plans and timelines. Work collaboratively to ensure all projects are appropriately prioritized and key goals are met on time. Regulatory Compliance (25%) Ensure compliance of regulatory strategies and submissions. Oversee preparation and review of regulatory submissions and responses. Monitor regulatory trends and ensure proactive strategy adjustments. Other duties and responsibilities as assigned. Qualifications Required Qualifications B.S/M.S. and 10+ years of work experience in pharmaceutical regulatory affairs 5+ years of regulatory experience working with global development and submission plans Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to oncology drug development in the US and EU Must have experience filing INDs and NDAs and engagement with FDA and other regulatory bodies Preferred Experience Capable of strategic thinking and proposing innovative solutions to regulatory problems Demonstrates excellent verbal and written communication skills Experience managing a regulatory team member Additional Information Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $162,200 - $223,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location. Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable) Benefits: Competitive salary and annual bonus. Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more. Generous parental leave and family planning benefits. Outstanding culture and opportunities for personal and professional growth. Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team! EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis. EQUAL EMPLOYMENT OPPORTUNITY INFORMATION Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

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: We are seeking an experienced and strategic Senior Director of CMC Process Development to lead our biologics process development function across early-stage, late-stage, and commercial programs. This role will drive the design, scale-up, and technology transfer of drug substance processes-both internally and through a global network of CDMOs. Expertise with drug substance process development for high-concentration biologics is essential.The ideal candidate combines deep technical knowledge, strong organizational leadership, and proven experience managing external collaborations and in-house teams. This role is critical to ensuring robust, scalable, processes that support clinical and commercial success. Key Responsibilities: Strategic & Functional Leadership Lead the CMC process development strategy for biologics (mAbs, fusion proteins, or similar), including upstream and downstream development. Serve as the enterprise thought leader for biologics manufacturing platforms, innovation, and process robustness. Partner with stakeholders across R&D, Regulatory, Manufacturing, and Quality to ensure alignment from development to commercial readiness. Technical Program Oversight Design and oversee process development programs across all stages (early/IND-enabling through BLA/commercial lifecycle). Guide scale-up, technology transfer, and validation activities across external manufacturing sites. Enable robust process ownership and technical oversight for clinical and commercial manufacturing. External CDMO Management Manage and oversee relationships with CDMOs for drug substance development, ensuring scientific rigor, quality, and timelines. Serve as the technical lead for external development and manufacturing partnerships, including CDMO selection and oversight of SOWs, budgets, and technical deliverables. Organizational Development Build and lead a high-performing CMC process development team, including technical experts and project leaders. Foster a culture of scientific excellence, cross-functional collaboration, and accountability. Regulatory Support Author and/or review CMC sections of regulatory submissions (IND, IMPD, BLA/MAA), including process descriptions, validation strategies, and control strategies. Support regulatory agency interactions, inspections, and responses to information requests. Qualifications: Required: Ph.D. or M.S. in Chemical Engineering, Biochemistry, or related field. 12+ years of relevant experience in biopharmaceutical process development, with at least 5 years in a leadership role. Proven experience developing biologics processes from early-stage through commercial launch, including PPQ and lifecycle management. Demonstrated expertise in drug substance process development of high-concentration biologics to mitigate drug product development challenges. Strong background in tech transfer, scale-up, and working with external CDMOs. Experience with process ownership and technical oversight for clinical and commercial manufacturing. Experience supporting global regulatory submissions (e.g., FDA, EMA). Preferred: Experience in a lean, entrepreneurial biotech environment. Familiarity with integrated CMC program leadership or technical operations governance frameworks Competencies: Strategic and enterprise mindset Deep technical expertise with strong decision-making capability Effective communicator with cross-functional and external partners Proactive, solution-oriented leadership style High standards of scientific rigor and compliance Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .

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 Associate Director, Field Reimbursement will support patients and caregivers by enhancing access to a potentially novel treatment option for individuals living with Spinal Muscular Atrophy (SMA). Acting as a trusted partner to healthcare providers and institutions (including C-suite, hospital administration and Pharmacy Directors), you will address reimbursement and access barriers through strategic account management, resource utilization and education. This role offers a unique opportunity to make a significant impact on the lives of individuals living with a rare neuromuscular disease by ensuring access, support, and continuity of care throughout their treatment journey. The Associate Director, Field Reimbursement will be a critical member of the broader Patient Access and Experience Team.Position Responsibilities: 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. Candidate Requirements: Bachelor's degree required; advanced degree preferred. Minimum of 3 years of relevant experience in reimbursement roles within the pharmaceutical or biotech space; prior account management, HUB/patient services and/or market access experience preferred. Experience in rare disease, buy & bill/specialty pharmacy, and understanding of complex provider and hospital reimbursement processes is required; prior launch experience preferred, to include knowledge of miscellaneous j-code reimbursement requirements. Experience with specialty or high-cost therapies in chronic or acute care settings is required, with a strong preference for those experienced in launching new therapies into infusion sites. Exceptional ability to develop and execute account-based strategies in a highly matrixed environment to ensure access and operational efficiencies. Adept at anticipating challenges and educating HPCs (and other critical stakeholders) to overcome patient access and affordability barriers. Ability to analyze complex data sets and derive actionable insights to prioritize activity and facilitate broad access opportunities within a geography or account. Strong understanding of the evolving patient access landscape to include payer, PBM, and SP interdependencies. Excellent written and verbal communication skills. Strong interpersonal skills, patient-centricity and flexibility to meet evolving customer and organizational needs Expertise in account management, relationship development (internal and external), and issue resolution. Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees .