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:
Playing a critical role within Scholar Rock, the Senior Director, GCP Quality Assurance will be relied upon as Subject Matter Expert in GCP Compliance with respect to planning, execution and close-out Clinical Studies. The Senior Director, GCP Quality Assurance coordinates GCP Compliance activities with Clinical Operations, Regulatory Affairs, Clinical Supply & Logistics, Sample Management and Pharmacovigilance as well as vendors supporting Scholar Rock sponsored Clinical Studies.
This is a high visibility role and will be directly involved in development and continuous improvement of GCP Quality and overall Quality Management Systems at Scholar Rock as we grow and mature organizationally. This individual will be responsible for coordinating with key stakeholders to develop/implement processes and systems governing GCP activities and will report into the Vice President of Quality Assurance.
Reporting to the Head of Quality Assurance, the Director/Sr. Director, Clinical Quality Assurance (CQA) is responsible for the development and implementation of processes and programs that provide quality and compliance oversight utilizing proactive end to end strategies for all clinical development programs, and pharmacovigilance activities. The incumbent is also responsible for the process and program that ensures appropriate computer system validation/assurance activities are completed for applicable clinical systems. The incumbent builds collaborative, supportive relationships and serves as the single point of accountability for Quality Assurance across all clinical development programs including Clinical Operations, Pharmacovigilance, Data Management, Biometrics and other relevant stakeholders. Supports and maintains a quality-focused culture and mindset across the organization.