Job DescriptionProvide 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.
Qualifications- Bachelor'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.
PhysicalDemandsandWorkEnvironment:- 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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