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Gubra is seeking a Senior Director or VP, Clinical Operations to lead the design, execution, and oversight of its growing early-to-mid-stage clinical trial portfolio. This role is a senior leadership appointment within the Development leadership team and reporting into the Chief Medical and Development Officer. You will own clinical operations strategy and delivery across Gubra's internal development programmes across multiple therapeutic areas, with responsibility for building and leading the clinical operations function from the ground up.
Job Responsibility
Build and lead the clinical operations function, including hiring, structuring, and developing an internal team as the pipeline grows across Phase I and II clinical trials
Own end-to-end operational delivery of Gubra's clinical trial portfolio, including GUB-UCN2 and future internal candidates, from study start-up through to close-out
Define and execute clinical operations strategy in close cross-functional partnership
Select, manage, and oversee performance of CROs and other external vendors, ensuring quality, timeline, and budget delivery across all studies
Establish robust clinical trial management systems, including vendor oversight, SOPs, and quality frameworks appropriate for a scaling, GCP-compliant clinical organisation
Manage clinical operations budgets and resourcing plans, providing regular progress and risk reporting to the executive team
Ensure inspection-readiness and compliance with ICH-GCP, EU Clinical Trials Regulation, and other applicable regulatory frameworks across all studies
Support investor and board-facing communications on clinical progress in partnership with the CDMO, CEO and Investor Relations
Requirements
10+ years' experience in clinical operations within biotech or pharma, including significant senior leadership experience (Director/VP level)
Proven track record of building or scaling a clinical operations function, ideally within a growing or transitioning biotech organisation
Direct experience managing early-phase (Phase 1/2) clinical trials, including first-in-human studies
Strong working knowledge of ICH-GCP, EU Clinical Trials Regulation, and clinical trial application processes in Europe and the USA
Fluent English required
Willingness to be based in the greater Copenhagen area or Basel area, and/or ability to travel to Gubra offices in Denmark on a regular basis
Experience working with or alongside large pharma partners on co-developed or licensed clinical programmes is highly advantageous
Background in metabolic disease, obesity, or peptide therapeutics is a strong plus, though not essential
Demonstrated ability to operate at both strategic and hands-on operational levels in a lean, fast-scaling organisation
Nice to have
Experience working with or alongside large pharma partners on co-developed or licensed clinical programmes
Background in metabolic disease, obesity, or peptide therapeutics
Demonstrated ability to operate at both strategic and hands-on operational levels in a lean, fast-scaling organisation
What we offer
A senior leadership role at a high-growth, NASDAQ-listed techbio with strong financial backing and a differentiated clinical pipeline
The opportunity to build a function from the ground up during a defining period of Gubra's expansion into clinical-stage development
Direct exposure to pharma and biotech partnerships and a fast-advancing portfolio within metabolic diseases and beyond
Competitive compensation
Equity participation
Hybrid working model based in Hørsholm, Denmark or Basel, Switzerland