Scholar Rock
Associate Director/Director, Clinical Operations Compliance
Cambridge, MA · Director
Sponsorship not specified$175k-$240kDetected 15 days ago
GCPVendor ManagementClinical TrialsClinical ResearchFDA RegulatoryPharmacovigilanceResearchCommunication
About the role
- 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.
- Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
- We celebrate diversity and are committed to creating an inclusive environment for all employees.
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.
- Support outsourcing partnerships through issue escalation, resolution, and CAPA mediation and documentation as a support to governance oversight.
- Review key documents in conjunction with other functional area leads (e.g. protocols, SOPs, project plans, and inspection requests, etc.).
Compensation
- $175k-$240k
Benefits
- Ensure consistent implementation of training and learning, including responsibility for managing functional training matrices and adherence by personnel, as well as oversight of vendor training and learning processes.
- Flexible to support in-office days.
Company info
- 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.
- 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.
Equal opportunity
- Scholar Rock is an Equal Opportunity Employer.
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This listing is sourced directly from Scholar Rock's careers page and normalized into a canonical job model.