Provide strategic and operational leadership for the planning, management, oversight, and execution of clinical programs in support of Alkermes’ R&D portfolio. This role is accountable for advancing programs across the development lifecycle, including lifecycle management (LCM) initiatives and supplemental NDA (sNDA) submissions, with a focus on high-quality, patient-centric execution.
Responsibilities• Responsible for planning, oversight and execution of assigned clinical programs: responsible for timelines, budget, and key deliverables as well as contributing to overall clinical strategy.
• Participates on Clinical Teams as operational representative, partnering closely with Clinical Science, Biostatistics, Regulatory, Medical Affairs, Translational Medicine, and other functions to shape and execute integrated clinical development plan
• Responsible for project budget/resource planning, re-forecasting, milestone, payment and variance tracking with Clinical Outsourcing & Finance, and Project Management.
• Establish and monitor program performance metrics, leveraging data and insights to continuously improve execution and inform leadership decision-making.
• Provides strategic input and oversight in development of clinical plans, protocols, SAPs, consent form development, and other program/study related documents.
• Works with clinical outsourcing, legal, and finance in the selection of CROs and vendors, and participates in contract and budget negotiations.
• Manages relationships and establishes strong partnerships with CROs, vendors, investigators and other external partners to ensure delivery of high-quality, timely outcomes.
• Partner with the Study Start-Up team on clinical start-up activities including feasibility, country selection/recommendation, budget & timeline planning, supply chain, and regulatory preparation.
• Provides oversight for project-related data integration/technology activities including IVRS, ePRO, central lab, etc along with data management department.
• Provides oversight and support to direct reports fostering talent development, performance management, and a culture aligned with Alkermes leadership expectations and values.
QualificationsBachelor’s Degree in life sciences or healthcare-related field; Master’s Degree preferred.
Minimum of 10 years of clinical development experience in a pharmaceutical/biotech or CRO setting.
Proven track record of leading global, complex clinical programs across multiple phases, with deep experience in Phase 4/LCM programs
Strong leadership presence with the ability to influence and drive alignment across cross-functional teams.
Excellent strategic thinking, organizational, and execution skills with the ability to manage competing priorities.
Strong knowledge and understanding of GCP/ICH Guidelines and regulatory requirements.
Physical Demands and Work Environment:
Ability to travel domestically and internationally (up to 20%)
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.
The annual base salary for this position ranges from $220,000 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.
Skills Required
- Bachelor's Degree in life sciences or healthcare-related field
- Master's Degree (preferred)
- Minimum of 10 years clinical development experience in pharmaceutical/biotech or CRO setting
- Proven track record leading global, complex clinical programs across multiple phases, with deep Phase 4/LCM experience
- Strong knowledge and understanding of GCP/ICH Guidelines and regulatory requirements
- Strong leadership presence with ability to influence and drive cross-functional alignment
- Excellent strategic thinking, organizational, and execution skills; ability to manage competing priorities
- Experience with project budget/resource planning, re-forecasting, milestone/payment/variance tracking
- Experience selecting and managing CROs/vendors, contract and budget negotiations
- Experience overseeing project-related data integration/technology activities (IVRS, ePRO, central lab) and working with data management
- Ability to travel domestically and internationally (up to 20%)
- Able to work hybrid: onsite in Waltham, MA at least 3 days per week (not eligible for fully remote)
- Experience managing and developing direct reports
What We Do
Alkermes focuses on the development of innovative medicines that seek to address unmet needs of people living with serious mental illness, addiction, and cancer. As a fully-integrated, global biopharmaceutical company, we apply our scientific expertise and proprietary technologies to develop products that are designed to make a meaningful difference in the way patients manage their disease. We are inspired by some of the most pressing public health challenges of our time to help advance innovation with the potential to improve treatment options and outcomes for patients. Beyond our important mission of developing medicines, we believe it is our responsibility to take a holistic approach as we seek to support patients, caregivers, and broader impacted communities. In this context we also work to help support and enhance the systems through which these complex diseases are treated. We are committed to patient engagement, disease education and awareness, and advocacy for important policies that support equitable access to quality treatment. Headquartered in Dublin, Ireland, we have an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. See our Community Guidelines: https://www.alkermes.com/social-community-guidelines
