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In this position, you will play a central role in driving cross-functional project execution across Gubra’s development projects. You will work closely together with colleagues across the Drug Development area to ensure clear project plans, strong coordination, clear ownership and efficient decision-making from pre-clinical development through clinical activities. You will also support seamless project transitions across Gubra´s internal pipeline, in collaboration with colleagues from Drug Discovery, supporting with a broad understanding of drug development in a growing and ambitious organization. You will join the Project Management team within the development area and report directly to the VP, Head of Project Management, Stine Jørgensen.
Job Responsibility
Management of Gubra’s drug development projects, ensuring alignment between project strategy, execution plans, timelines, budget and organizational priorities
Drive cross-functional project team activities, ensuring clear ownership, effective decision-making and timely progress across drug development disciplines
Translate project strategy into integrated development plans, timelines and governance material for both internal and external stakeholders
Identify, assess and manage project risks, dependencies and critical path activities, ensuring proactive mitigations and timely escalation when needed
Support governance processes by facilitating alignment across stakeholders, drive decision readiness and maintain an overview of decisions and actions
Ensure that project activities are conducted in alignment with applicable GxP requirements, internal procedures, and regulatory expectations, in close collaboration with QA and functional experts
Oversee external consultants, vendors, and service providers, including selection, scope definition, agreements, task delegation, performance follow-up, and integration into project execution
Requirements
MSc and PhD or equivalent degree in natural, health, pharmaceutical, or life sciences
10+ years of relevant experience in Drug Development, including hands-on project leadership
Extensive experience with project management, leading projects through early clinical phases (up to Phase 2a)
Experience in managing key project deliverables, including preparing and driving a development plan and managing budgets as well as the ability to coordinate cross-functional teams and define critical project milestones
Background in biotech, pharma or similar environments requiring broad, hands-on project leadership
Excellent communication and presentation skills, when engaging with both scientific and non-scientific stakeholders, including senior management and external partners (CROs and CMOs)
Experience with CTA/IND-enabling activities, as well as an understanding of regulatory milestones is a strong advantage
Experience beyond Phase 2a is considered an advantage
Excellent people skills and a proven ability to lead successful project teams via informal leadership in matrix organizations
Strong communication skills, with the ability to translate complexity into clear and actionable guidance on project strategy
Structure and strong organizational skills, to ensure adherence to processes and governance
An adaptable, collaborative mindset suited to a growing biotech environment and comfortable working in an environment where priorities may evolve
Nice to have
Experience with CTA/IND-enabling activities, as well as an understanding of regulatory milestones is a strong advantage
Experience beyond Phase 2a is considered an advantage