Director, Phase 1 Clinical Operations (Hybrid)

Alkermes; Waltham (MA); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Alkermes is seeking a Director of Clinical Operations to lead Phase 1 healthy volunteer studies, partnering across Clinical Pharmacology, Translational Medicine, Medical and Biostatistics. The role ensures GCP/FDA/ICH compliance, budgets, forecasting, and vendor management across early development studies, with hybrid work requiring onsite presence in Waltham, MA at least 3 days per week.

The successful candidate will drive operational strategy, inspection readiness and continuous process

Qualifications

• Proven ability to lead Phase 1 healthy volunteer studies.
• Strong understanding of GCP, FDA regulations and ICH guidelines.
• Experience managing study budgets, forecasting and resource planning.
• Ability to drive inspection readiness and continuous process improvement.

Responsibilities

• Oversee study budgets, forecasting and resource planning.
• Define operational strategy and timeline adherence for early development trials.
• Ensure inspection readiness and eTMF oversight.
• Manage vendor relationships and CRO partnerships.
• Identify risks and implement proactive mitigations to ensure on-time delivery.

Skills

Leadership

Budgeting

Forecasting

Vendor management

Regulatory compliance

Study management

Tools

eTMF

Job description

Alkermes is seeking a Director of Clinical Operations to lead Phase 1 healthy volunteer studies, partnering across Clinical Pharmacology, Translational Medicine, Medical and Biostatistics. The role ensures GCP/FDA/ICH compliance, budgets, forecasting, and vendor management across early development studies, with hybrid work requiring onsite presence in Waltham, MA at least 3 days per week.

The successful candidate will drive operational strategy, inspection readiness and continuous process