Director, Phase 1 Clinical Operations (Hybrid)

Alkermes; Massachusetts; Hybrid; USD 219,000 - 235,000; Full time

Job summary

The Director of Clinical Operations at Alkermes leads Phase 1 healthy volunteer studies, coordinating across Clinical Pharmacology, Translational Medicine, Medical, Biostatistics, Regulatory Affairs, and CRO partners to ensure on-time, compliant deliverables.

The role manages budgets, timelines, vendor relationships, eTMF oversight, and continuous process improvements, with a hybrid work arrangement requiring 3 days in Waltham, MA and 2 days remote.

Qualifications

• BS, MS, or PhD in basic sciences with 12+ years of Clinical Operations experience.
• Minimum of 5 years managing Phase 1 studies in healthy volunteers.

Responsibilities

• Lead planning, execution, and delivery of Phase 1 clinical studies in healthy volunteers.
• Develop and manage study timelines, budgets, forecasts, and resource plans.
• Provide operational input into protocol development and study design.
• Oversee CROs, Phase 1 units, laboratories, and clinical vendors.
• Ensure compliance with FDA regulations, ICH-GCP guidelines, and SOPs.
• Maintain inspection readiness and oversee eTMF quality.

Skills

12+ years Clinical Ops

Phase 1 studies management

Education

BS/MS/PhD in basic sciences

Job description

The Director of Clinical Operations at Alkermes leads Phase 1 healthy volunteer studies, coordinating across Clinical Pharmacology, Translational Medicine, Medical, Biostatistics, Regulatory Affairs, and CRO partners to ensure on-time, compliant deliverables.

The role manages budgets, timelines, vendor relationships, eTMF oversight, and continuous process improvements, with a hybrid work arrangement requiring 3 days in Waltham, MA and 2 days remote.