Director, Clinical Program Management

Alkermes

6d•Hybrid

About The Position

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.

Requirements

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.

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.
Participate 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 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.
Provide 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.