Director, Clinical Operations

Socket.dev; Waltham (MA); Hybrid; USD 219,000 - 235,000; Full time

Job summary

Alkermes is seeking a Director of Clinical Operations to lead Phase 1 studies in healthy volunteers and ensure compliance with GCP, FDA regulations, ICH guidelines, and company SOPs.

The role partners with Clinical Pharmacology, Translational Medicine, Medical, Biostatistics, Regulatory Affairs, and CROs to deliver studies on time and within budget while maintaining inspection readiness and eTMF quality. Hybrid work requires onsite presence in Waltham, MA at least 3 days/week.

Qualifications

• Experience leading Phase 1 studies in healthy volunteers.
• Strong budgeting, forecasting and resource-planning skills.
• Proven ability to manage CROs, vendors, and study sites.
• Deep knowledge of FDA, ICH-GCP and regulatory requirements.

Responsibilities

• Lead planning, execution, and delivery of Phase 1 studies (FIH, SAD/MAD, BA/BE, DDI, etc.).
• Develop study timelines, budgets, forecasts and resource plans.
• Provide operational input into protocol development and risk mitigation.
• Oversee CROs, Phase 1 units, labs, and vendors for quality and timelines.
• Ensure FDA/ICH-GCP compliance and SOP adherence across studies.
• Collaborate with Clinical Pharmacology, Regulatory Affairs, Biostatistics, Medical, Safety, and Clinical Supply.
• Maintain inspection readiness and oversee eTMF integrity and filing.
• Monitor study progress, enrollment, safety, data quality, and KPIs.
• Support IND submissions, amendments, inspections, and CSR activities.
• Lead SOP development, process mapping, and team mentoring.

Skills

Phase 1 studies

Budgeting & forecasting

Vendor management

Regulatory compliance

Education

B.S., M.S. or Ph.D. in basic sciences

Tools

eTMF system

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.

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.

Qualifications

Basic Qualifications:

• 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

Preferred Qualifications:

• Prior people management experience preferred.

• Expertise in Subject Matter and competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance)

The annual base salary for this position ranges from $219,000 to $235,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here

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Why join Team Alkermes?

Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult‑to‑treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.

We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.