Associate Director, Clinical Operations
$170,000–$215,000 year
Hybrid · Needham, Massachusetts, United States
Job Summary
Associate Director, Clinical Operations to lead end-to-end execution of global oncology studies (Phase 2/3) with strategic oversight, cross-functional collaboration, and budget/operational accountability. Responsibilities include planning and executing studies, coordinating startups through database lock and closeout, overseeing CROs/vendors, monitoring progress and risks, contributing to study protocol and manuals, inspection readiness, budgeting and accrual forecasting, SOP development, and mentoring junior team members. Requires a scientific/medical degree, ~8+ years of clinical operations experience in biotech/pharma, strong ICH-GCP knowledge, experience with CROs, and leadership in a fast-paced biotech environment. Hybrid work arrangement in Greater Boston area with periodic travel to Needham, MA office.
Required Qualifications
- Bachelor’s degree in a scientific, medical, or healthcare-related discipline required; advanced degree preferred
- 8+ years of progressive experience in clinical trial operations
- Experience independently managing complex Phase 2 and Phase 3 oncology clinical trials
- Strong understanding of ICH-GCP guidelines and global regulatory requirements governing clinical research
- Experience overseeing CROs, external vendors, and global study execution in a biotech or pharmaceutical environment
- Proven ability to manage operational complexity while remaining hands-on and solutions-oriented
- High emotional intelligence, strong collaboration skills, and a humble, team-first mindset
- Bachelor’s degree required; advanced degree preferred
Desired Qualifications
- Bachelor’s degree in a scientific, medical, or healthcare-related discipline required; advanced degree preferred
- 8+ years of progressive experience in clinical trial operations
- Experience managing Phase 2 and Phase 3 oncology trials
- Strong understanding of ICH-GCP and global regulatory requirements
- Experience overseeing CROs and external vendors in biotech/pharma
- Mentoring/junior team development
- Operational planning and budget management
- Regulatory inspections and inspection readiness
- Cross-functional leadership and effective communication skills
- Site activation, enrollment tracking, monitoring oversight, and issue escalation
- SOP development and process optimization
- Hands-on, solutions-oriented leadership in fast-paced biotech environments
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