Associate Director, Program Management

GEMMABio is advancing a diverse portfolio of gene therapy programs across multiple therapeutic areas, including neuromuscular, cardiovascular, oncology, metabolic, and infectious diseases.

As the Associate Director, Program Management, you will report to the Executive Director, Project Management to guide teams in achieving GEMMABio’s goals for clinical stage gene therapy assets for rare diseases.

Key Responsibilities

• Collaborate with Clinical, Regulatory, and CMC Teams on the Clinical Development Plan to define cross-functional deliverables and timelines.
• Manage and control the cross-functional timeline for executing the Clinical Development Plan to BLA/MAA filing.
• Lead cross-functional teams to ensure alignment with corporate strategy, timely execution of plans, and budget adherence.
• Facilitate decision making and outline risk strategies.
• Engage with external preclinical and clinical Contract Research Organizations (CROs) as well as Contract Development and Manufacturing Organizations (CDMOs) to coordinate and facilitate meetings in collaboration with the Therapeutic, Clinical, Regulatory, or CMC leads. Document the outcomes, actions, and risks to ensure program deliverables are met.
• Work with line management and the Executive Director on improving processes impacting clinical programs.
• Escalate issues affecting project priorities to line management and the Executive Director.
• Align meeting management processes with R&D and CMC Leadership.
• Develop and track Key Performance Indicators (KPIs) with PM team leadership.

Qualifications