About the role
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 ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
Summary of Position:**
Scholar Rock is looking for an associate or director-level subject matter expert to build clinical operations compliance while upholding our core values and staying true to our mission. Reporting to the Head of Clinical Operations, the Director, Clinical Operations Compliance will play a key role in oversight of adherence to standard procedures and support of issue management for the clinical programs, and ensuring programs are inspection ready.
Position Responsibilities
- Ensure consistency in the implementation of clinical project plans by providing reviews and support template development or refinement.
- Lead initiatives, create process/ standards, and ensure consistency, communication, and change management across Clinical Operations, specifically related to SOP and work instruction creation and management, outsourcing, and compliance.
- Partner with cross-functional team members within Regulatory, Quality, Data Sciences, Clinical Research, Pharmacovigilance, and other key cross-functional groups to support department compliance objectives.
- Develop TMF standards and oversight in support of inspection readiness Develop or refine Standard Operating Procedures (SOPs), vendor endorsement team process, and functional builds, e.g. TMF standards.