Director, Clinical Program Management

Alkermes

3d•Hybrid

About The Position

Provide strategic and operational leadership for the planning, management, oversight, and execution of clinical programs supporting Alkermes’ R&D portfolio. The role is accountable for advancing programs across the development lifecycle, including lifecycle management (LCM) initiatives and supplemental NDA (sNDA) submissions, with an emphasis on high-quality, patient-centric execution. The position uses Alkermes’ hybrid workplace model. Work must be completed onsite at the Waltham, Massachusetts office at least three days per week, with the stated work arrangement of 60% in the office and 40% from home. Fully remote work is not available. Domestic and international travel of up to 20% is required.

Requirements

Bachelor’s degree in life sciences or a healthcare-related field.
At least 10 years of clinical development experience in a pharmaceutical, biotechnology, or CRO setting.
Ability to travel domestically and internationally up to 20%.

Nice To Haves

Master’s degree.
Proven track record of leading global, complex clinical programs across multiple phases, with deep experience in Phase 4 and lifecycle management programs.
Strong leadership presence and ability to influence and drive alignment across cross-functional teams.
Excellent strategic thinking, organizational, and execution skills, including the ability to manage competing priorities.
Strong knowledge and understanding of GCP/ICH Guidelines and regulatory requirements.

Responsibilities

Plan, oversee, and execute assigned clinical programs, including timelines, budgets, key deliverables, and contributions to overall clinical strategy.
Participate on Clinical Teams as the operational representative and partner with Clinical Science, Biostatistics, Regulatory, Medical Affairs, Translational Medicine, and other functions to shape and execute integrated clinical development plans.
Manage project budget and resource planning, re-forecasting, milestone and payment tracking, and variance tracking with Clinical Outsourcing, Finance, and Project Management.
Establish and monitor program performance metrics, using data and insights to improve execution and inform leadership decision-making.
Provide strategic input and oversight for clinical plans, protocols, statistical analysis plans (SAPs), consent forms, and other program- and study-related documents.
Work with clinical outsourcing, legal, and finance teams to select CROs and vendors and participate in contract and budget negotiations.
Manage relationships and build partnerships with CROs, vendors, investigators, and other external partners to support high-quality, timely outcomes.
Partner with the Study Start-Up team on feasibility, country selection and recommendations, budget and timeline planning, supply chain, and regulatory preparation.
Oversee project-related data integration and technology activities, including IVRS, ePRO, and central laboratory activities, in coordination with the data management department.
Provide oversight and support to direct reports, fostering talent development, performance management, and a culture aligned with Alkermes leadership expectations and values.