Director, Clinical Program Management
About The Position
Provide strategic and operational leadership for 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 a focus on high-quality, patient-centric execution. The position follows Alkermes’ hybrid workplace model: work is completed onsite at the Waltham, Massachusetts office at least three days per week, with approximately 60% of time in the office and 40% from home. It is not eligible for fully remote work. 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.
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 responsibility for timelines, budgets, key deliverables, and contributions to overall clinical strategy.
- Participate on Clinical Teams as the operational representative, partnering with Clinical Science, Biostatistics, Regulatory, Medical Affairs, Translational Medicine, and other functions to shape and execute the integrated clinical development plan.
- Manage project budget and resource planning, re-forecasting, milestone, payment, 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 in developing clinical plans, protocols, statistical analysis plans (SAPs), consent forms, and other program- or study-related documents.
- Work with clinical outsourcing, legal, and finance in selecting CROs and vendors, and participate in contract and budget negotiations.
- Manage relationships and establish partnerships with CROs, vendors, investigators, and other external partners to ensure high-quality, timely outcomes.
- Partner with the Study Start-Up team on clinical start-up activities, including 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 work, in collaboration 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.
Benefits
- Annual performance pay bonus eligibility.
- Competitive benefits package.
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What This Job Offers
Job Type
Full-time
Career Level
Director
