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Job Summary
As Senior Director of Portfolio Management at GEMMABio, you will lead the Program Management team in driving strategic execution across preclinical and clinical-stage gene therapy programs targeting rare diseases. This role is pivotal in aligning cross-functional efforts with GEMMABio’s portfolio objectives and ensuring timely, budget-conscious delivery of key milestones.
Key Responsibilities
- Strategic Leadership & Alignment
- Partner with the Executive and Management teams to shape and execute strategies for GEMMABio’s lead assets.
- Collaborate with the COO and leadership team to manage program prioritization and resource allocation.
- Lead and facilitate meetings across all organizational levels to ensure alignment with corporate strategy and execution of program plans.
- Ensure working group meetings are agenda-driven and focused on efficient decision-making.
- Program Oversight & Execution
- Develop and maintain integrated program development plans, including cross-functional timelines, milestones, dependencies, and critical paths through BLA/MAA filing.
- Collaborate with R&D (Preclinical, Clinical, Regulatory, QA, and CMC) teams to define and manage departmental deliverables and timelines.
- Oversee Supply Chain activities to support effective operational execution.
- Drive accountability across departments and facilitate risk mitigation strategies and contingency planning.
- Facilitate program budgeting by partnering with R&D departments and Finance to ensure accurate forecasting, alignment with strategic priorities, and adherence to budgetary constraints.
- Operational Excellence
- Lead strategic initiatives that impact program execution and portfolio success.
- Champion process improvements within R&D operations, working closely with R&D and CMC leadership to optimize meeting management and cross-functional workflows.
- External Collaboration & Alliance Management
- Serve as the primary point of contact for sponsored research agreements, ensuring alignment with sponsor and internal team expectations.
- Oversee delivery of sponsored programs within scope and timelines, and act as a key escalation point for project-related issues.
- May lead one or more external preclinical-stage sponsored research projects.
- Performance & Team Leadership
- Define and track Key Performance Indicators (KPIs) for the Portfolio Management department.
Supervise and mentor a team of 2–4 direct reports, fostering professional growth and operational excellence
Qualifications
- Master's Degree (life sciences or molecular biology desired) and 10 years of applicable experience in program management is required.
- PMP or PMI certification beneficial but not required.
- Strong leader with experience in developing and leading high-performance cross-functional teams to achieve desired outcomes with internal and external teams.
- 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.
- Experience focused on clinical assets with hands on experience in filing a BLA with the FDA is beneficial. Experience in the rare disease space is beneficial.
- 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 dynamic environment.
- Strong analytical and critical thinking skills required.
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