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

• Master's Degree (life sciences or molecular biology desired) and 5-7 years of applicable experience in program management is required.
• PMP or PMI certification beneficial but not required.
• Experience focused on clinical trials for rare diseases; with hands on experience in filing a BLA with the FDA, a plus.
• Experience in project management with the ability to develop clear action plans and execute.
• Experience managing multiple complex programs and demonstrated adeptness with dynamic prioritization of deliverables and resources.
• Knowledge of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical studies is beneficial.
• Ability to perform well under pressure and embrace a dynamic environment.
• Strong analytical and critical thinking skills required.

Summary