Global Clinical Operations Lead - Associate Director

Cogent Biosciences; Waltham (MA); On-site; USD 185,000 - 215,000; Full time

Benefits offered by this job

Premium health/dental/vision coverage

401(k) with immediate vesting

Job summary

Cogent Biosciences is a publicly traded biotech company focused on precision therapies. We are seeking an Associate Director, Clinical Operations to lead global clinical development programs, serving as both hands-on study leader and strategic clinical operations partner.

The role balances operational detail with program oversight, driving execution across early- and later-stage development, identifying risks, and scaling operational excellence within a growing organization.

Qualifications

• BS/BA degree in science or health-related field (preferred).
• 6-7+ years in clinical development.
• Experience with complex therapeutic platforms & multi-phase trials.
• Experience with trial/site startup, vendor selection and management.

Responsibilities

• Lead clinical operations for global studies ensuring on-time, on-budget delivery with CRO/vendor oversight.
• Develop study performance metrics and drive corrective actions; assess site trends and risks.
• Partner with external stakeholders; chair study team meetings and update cross-functional teams on milestones.
• Contribute to protocol reviews, study manuals, ICFs, CRFs, and training materials.
• Support preparation of study reports and Investigator Brochures; assist data cleaning and listings.
• Evaluate and negotiate contracts and budgets with CROs, sites, and vendors.
• Perform site monitoring activities, including onsite/remote monitoring and sponsor oversight.
• Maintain study documentation per regulations, SOPs, and ICH/GCP.

Skills

Clinical operations leadership

Study management

Vendor management

GCP/ICH/FDA knowledge

Cross-functional collaboration

Education

BS/BA in science or health-related field

Tools

Data management processes

SOP review & development

Job description

Cogent Biosciences is a publicly traded biotech company focused on precision therapies. We are seeking an Associate Director, Clinical Operations to lead global clinical development programs, serving as both hands-on study leader and strategic clinical operations partner.

The role balances operational detail with program oversight, driving execution across early- and later-stage development, identifying risks, and scaling operational excellence within a growing organization.