Director, Clinical Operations

Alkermes•Waltham, MA

14h•$219,000 - $235,000•Hybrid

About The Position

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.

Requirements

B.S, M.S or Ph.D in basic sciences with 12+ years of Clinical Operations experience at biotechnology or pharmaceutical company or CRO
Minimum of 5 yrs managing Phase 1 Studies in healthy volunteers

Nice To Haves

Prior people management experience preferred.
Expertise in Subject Matter and competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance)

Responsibilities

Lead planning, execution, and delivery of Phase 1 clinical studies, including FIH, SAD/MAD, food effect, BA/BE, HAP, TQT, DDI, and other studies in healthy volunteers.
Develop and manage study timelines, budgets, forecasts, and resource plans to ensure on-time and on-budget delivery.
Provide operational input into protocol development, study design, feasibility assessments, and risk mitigation strategies.
Oversee CROs, Phase 1 units, laboratories, and clinical vendors, ensuring quality, performance, and adherence to study objectives.
Ensure compliance with FDA regulations, ICH-GCP guidelines, company SOPs, and applicable global regulatory requirements.
Partner with Clinical Pharmacology, Translational Medicine, Regulatory Affairs, Biostatistics, Medical, Safety, and Clinical Supply teams to support study execution and development objectives.
Maintain inspection readiness and oversee eTMF quality, completeness, and timely document filing throughout the study lifecycle.
Monitor study progress, enrollment, safety, data quality, and operational metrics, proactively addressing risks and issues.
Support IND submissions, protocol amendments, regulatory inspections, audit readiness, study closeout, and CSR activities.
Participate in SOP development, process mapping, and other departmental activities.
Lead, mentor, and develop Clinical Operations staff while driving operational excellence, process improvements, and a culture of quality and accountability.