Sr. Director, Head of Clinical Quality Assurance

Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the Company is named for the visual resemblance of a scholar rock to protein structures.

Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at  and follow @Scholar Rock on X and on Linked In.

Scholar Rock is seeking an experienced and motivated Senior Director, Head of Clinical Quality Assurance to provide strategic and operational leadership for Good Clinical Practice (GCP) quality across the company’s biologics clinical development portfolio. Reporting to the Head of Global Quality, this role will serve as the senior Clinical QA leader and trusted partner to Clinical Operations, Clinical Development, Regulatory Affairs, Pharmacovigilance, Biometrics, Data Management, and external clinical service providers.

The position is accountable for clinical quality strategy, GCP quality systems, clinical quality risk management, CRO and vendor oversight, audit strategy, inspection readiness, quality metrics, and the maturation of fit-for-purpose processes that embed quality by design across the clinical trial lifecycle.

• Lead the Clinical Quality Assurance function, providing strategic direction and operational oversight for GCP quality across Scholar Rock-sponsored clinical trials, with a focus on biologics development programs.
• Serve as the senior GCP Quality partner to Clinical Operations, Clinical Development, Regulatory Affairs, Pharmacovigilance, Biometrics, Data Management, and other cross-functional stakeholders.
• Define, implement, and continuously mature the clinical quality strategy, governance model, and GCP quality management processes aligned with global regulatory expectations and clinical development priorities.
• Provide quality oversight for global clinical trials, including protocol compliance, informed consent processes, investigator site oversight, trial master file quality, data integrity, safety reporting interfaces, and clinical study documentation.
• Establish and execute a risk-based GCP audit program, including audits of investigator sites, CROs, vendors, clinical systems, TMF processes, and key internal clinical trial activities.
• Lead GCP inspection readiness activities and support preparation, conduct, response development, and follow-up for FDA, EMA, PMDA, and other health authority inspections.
• Provide oversight of GCP deviations, serious breaches, audit observations, inspection findings, CAPAs, and quality issues to ensure timely investigation, appropriate root cause analysis, effective corrective actions, and sustainable remediation.
• Oversee CRO and clinical vendor quality governance, including qualification, risk assessment, quality agreements where applicable, performance metrics, issue escalation, and continuous improvement.
• Partner with clinical and regulatory teams to proactively identify and mitigate quality risks associated with study design, trial execution, vendor performance, data integrity, patient safety, protocol deviations, and submission readiness.
• Develop and monitor GCP quality metrics,…