Director, Clinical Operations Compliance

Scholar Rock; Cambridge (MA); Hybrid; USD 175,000 - 240,000; Full time

Job summary

Scholar Rock is seeking an Associate Director/Director, Clinical Operations Compliance to build and oversee clinical operations compliance, ensuring programs are inspection ready and aligned with SOPs. Reporting to the Head of Clinical Operations, this role coordinates with Regulatory, Quality, and other cross-functional teams to sustain high standards and effective issue management.

The candidate will supervise and educate teams, develop TMF standards, and support governance through CAPA and

Qualifications

• Bachelor’s Degree (scientific discipline preferred); advanced degree preferred.
• Minimum 8 years in biotech/pharmaceutical/CRO setting; minimum 6 years of clinical operations; minimum 3 years supervisory.
• Proven record of success supporting complex drug development trials, including inspection readiness.
• Demonstration of effective leadership through vision for her/his team, coaching and mentoring.
• Excellent knowledge and experience with federal regulatory requirements and guidelines for Good Clinical Practice (GCP).
• Outstanding oral and written communication skills including authoring and driving SOPs and trial documents.

Responsibilities

• Ensure consistency in clinical project plan implementation with reviews and template development/refinement.
• Lead initiatives, create processes/standards, and ensure cross-functional alignment for SOPs and work instructions.
• Collaborate with Regulatory, Quality, Data Sciences, Clinical Research, Pharmacovigilance, and other groups to meet compliance objectives.
• Develop TMF standards and oversight to support inspection readiness; create/refine SOPs and vendor processes.
• Support outsourcing partnerships via issue escalation, CAPA mediation, and governance documentation.
• Provide compliance oversight of trial management, site monitoring, vendor management, TMF, data operations, and closeout activities.

Skills

Leadership

Compliance

Training oversight

Vendor management

Regulatory knowledge

Education

Bachelor's Degree in science

Advanced degree preferred

Job description

Scholar Rock is seeking an Associate Director/Director, Clinical Operations Compliance to build and oversee clinical operations compliance, ensuring programs are inspection ready and aligned with SOPs. Reporting to the Head of Clinical Operations, this role coordinates with Regulatory, Quality, and other cross-functional teams to sustain high standards and effective issue management.

The candidate will supervise and educate teams, develop TMF standards, and support governance through CAPA and