Scholar Rock is a biopharmaceutical company dedicated to discovering, developing, and delivering transformative treatments for individuals with serious diseases that lack effective therapies. As a global leader in the biology of the transforming growth factor beta (TGFβ) protein family—and named for the resemblance of scholar rocks to protein structures—the company focuses on pioneering therapies where protein growth factors are central to disease. Over the last ten years, Scholar Rock has built a robust pipeline aimed at improving treatment standards for neuromuscular disorders, cardiometabolic diseases, cancer, and other conditions where targeting growth factors can have a significant impact.

Scholar Rock is the only company to demonstrate clinical proof of concept for a muscle-directed therapy in spinal muscular atrophy (SMA). Its innovative approach is driven by a proprietary platform that creates highly selective monoclonal antibodies to modulate protein growth factors. By applying advanced science to areas traditionally underserved by conventional treatments, Scholar Rock is committed to opening new therapeutic possibilities for patients. Learn more at ScholarRock.com and follow the company on Twitter @ScholarRock and LinkedIn.

Summary of Position:
The Senior Clinical Trial Manager is responsible for overseeing the operational execution of clinical studies from initiation to final reporting, with guidance from Clinical Operations Leadership. Depending on the study’s scope, this role may involve coordinating internal team members (e.g., Clinical Research Associates, Data Managers) and managing external vendors or consultants. The Senior Clinical Trial Manager may also take on specialized roles in ongoing studies, such as Lead Clinical Research Associate or Trial Master File Specialist.

Position Responsibilities:

– Execute clinical project plans in alignment with study protocols, timelines, and regulatory/corporate goals
– Lead internal project team meetings
– Ensure the Trial Master File (TMF/eTMF) is properly established and maintained
– Oversee all aspects of study start-up, including CRO selection
– Serve as the main contact for clinical sites, vendors, and CROs
– Monitor vendor and CRO compliance with scope of work
– Manage relationships with investigators and sites to ensure regulatory compliance
– Identify and address issues that could delay study completion
– Prepare and manage clinical trial budgets and assist with contract reviews
– Participate in audits involving vendors, sites, and CROs
– Conduct site monitoring visits as needed
– Organize and present at Investigator Meetings and internal company meetings
– Create tools for tracking and reporting study progress to leadership
– Follow all departmental SOPs, GCP/ICH guidelines, and quality procedures
– Travel domestically and internationally up to 20% as required
– Perform other duties as assigned

Candidate Requirements:

– Bachelor’s degree in a scientific field; advanced degree preferred
– At least 5 years of experience in biotech, pharmaceutical, CRO, clinical research, or related healthcare settings
– Experience with multi-phase clinical programs or across different phases of drug development
– Highly organized, goal-oriented, and self-driven
– Comfortable working in a dynamic, fast-paced environment
– Strong interpersonal skills with the ability to build relationships across disciplines; skilled in conflict resolution and negotiation
– Capable of analyzing complex problems and developing practical solutions
– Solid understanding of the drug development process
– Familiarity with federal regulations and Good Clinical Practice guidelines
– Excellent written and verbal communication skills

Scholar Rock is an Equal Opportunity Employer. We value diversity and are committed to fostering an inclusive workplace for all employees.