Associate Director/Director, Clinical Operations Compliance

Job overview

The Associate Director/Director, Clinical Operations Compliance is an onsite role in Cambridge, MA, with flexibility to support in-office days. Compensation is $175,000–$240,000 per year. Scholar Rock develops treatment approaches for spinal muscular atrophy and other rare neuromuscular diseases. The role builds and oversees clinical operations compliance, helping clinical programs follow procedures and remain inspection-ready. It establishes and refines processes, partners with cross-functional teams and vendors, and supports issue resolution, training, and regulatory submissions across the trial lifecycle.

What you'll do

• Review clinical project plans and support template development or refinement
• lead SOP and work-instruction processes, outsourcing, and compliance initiatives
• partner with Regulatory, Quality, Data Sciences, Clinical Research, and Pharmacovigilance
• develop and oversee Trial Master File standards
• support outsourcing issue escalation, resolution, and CAPA documentation
• oversee compliance across clinical trial activities
• review key documents
• manage training matrices and vendor training oversight
• contribute to global clinical and regulatory submissions
• assist with mock and site inspection readiness
• educate and engage stakeholders.

What we're looking for

Skills & competencies

clinical operations compliance

associate director

director

clinical trials

gcp

sops

inspection readiness

trial master file

vendor oversight

regulatory compliance

cambridge ma

scholar rock

$175k–$240k/year

Work arrangement

• Weekend coverage required

Why this role

Requires at least eight years in biotech, pharmaceutical, or CRO settings, including six years in clinical operations and three years in a supervisory role; may require domestic or international travel.

About the employer

Scholar Rock is hiring for this role. Industry: Offices of Physicians (except Mental Health Specialists). Sector: 62.