Director, Clinical Program Management

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

Basic 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

Preferred Qualifications:

• 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%)