Associate Director, Clinical Operations - Study Lead

BioSpace; Waltham (MA); On-site; USD 165,000 - 200,000; Full time

Job summary

Dyne Therapeutics in Waltham, MA is seeking a Clinical Operations Study Lead to translate clinical strategies into operational plans and drive trials across phases, CROs and vendors.

The role ensures study conduct adheres to ICH GCP, local regulations and company SOPs, with responsibility for budgeting, timelines and quality.

Travel up to 20%, cross‑functional leadership, data monitoring oversight, investigator meetings and patient enrollment activities are part of the day‑to‑day.

Qualifications

• 8+ years of clinical trial management experience in Phase I-III global trials.
• Experience across sponsor and CRO oversight and collaboration.
• Neuromuscular or muscle disease experience preferred.
• Solid understanding of ICH/GCP and regulatory requirements.
• Ability to lead teams in a fast-paced, matrixed environment.
• Willingness to travel up to 20% (including international).
• Excellent communication and problem-solving skills.

Responsibilities

• Manage operational aspects from start-up to close-out of studies.
• Develop study-level operational strategy in support of CDP.
• Oversee budgeting, forecasting, and vendor performance.
• Coordinate CRO oversight and ensure compliance with regulations.
• Lead cross-functional study teams and sponsor oversight activities.
• Support investigator meetings and patient enrollment efforts.
• Ensure data quality, safety reviews, and TMF readiness.

Skills

Clinical trial management

Cross-functional leadership

Budget forecasting

Vendor management

ICH/GCP compliance

Travel readiness

Team leadership

Communication skills

Education

Undergraduate degree in science/health

Advanced degree desirable

Job description

Dyne Therapeutics in Waltham, MA is seeking a Clinical Operations Study Lead to translate clinical strategies into operational plans and drive trials across phases, CROs and vendors.

The role ensures study conduct adheres to ICH GCP, local regulations and company SOPs, with responsibility for budgeting, timelines and quality.

Travel up to 20%, cross‑functional leadership, data monitoring oversight, investigator meetings and patient enrollment activities are part of the day‑to‑day.