Director, Clinical Operations

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

The Director of Clinical Operations in the Discovery Medicine and Pharmaceutical Sciences plays a central role in the execution of Phase 1 clinical studies conducted in healthy volunteers at Alkermes. This role provides operational leadership for healthy volunteer studies across the clinical development lifecycle, ensuring studies are conducted in compliance with GCP, FDA regulations, ICH guidelines, company SOPs, and project timelines.

The Director will partner closely with Clinical Pharmacology, Translational Medicine, Medical, Biometrics, Regulatory Affairs, Clinical Supply, Quality Assurance, Pharmacovigilance, and CRO partners to ensure successful execution of first-in-human (FIH), SAD, MAD, food effect, relative bioavailability, DDI, QTc, and other early development studies in healthy volunteers.

The successful candidate will be responsible for study budgets, forecasting, resource planning, operational strategy, inspection readiness, eTMF oversight, vendor management, and continuous process improvement and proactive risk identification to ensure on-time delivery of quality trials that meet the highest level of compliance.

Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.