Company name: ONA Therapeutics

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Job location: Barcelona, Catalonia, Spain (On-site, hybrid, or remote)

Reporting line: C-level

Company Description

Ona Therapeutics is a biotech company located in Barcelona (Parc Científic de Barcelona, PCB), focused on developing first-in-class antibody drug conjugates (ADCs) for advanced cancer treatment. By partnering with leading academics and clinicians, we identify novel therapeutic targets from the unique biology of treatment refractory advanced cancer patients, to provide effective new treatments for patients with no remaining alternatives.

Scope

The Director Preclinical & Regulatory Development will be responsible for defining the strategy, planning, coordinating, and driving all toxicology, pharmacokinetics, regulatory, and quality-related activities required to advance ONA’s ADC development programs in oncology from candidate nomination through clinical proof of concept.

Role and Responsibilities





Program Leadership & Project Management
- Integrate the functional strategies for toxicology, pharmacokinetics, regulatory affairs, and quality into a single, coherent ADC development strategy, in collaboration with an internal/external team of subject matter experts.
- Lead cross-functional development plans from candidate nomination through first-in-human studies and early clinical development, enabling a robust and efficient transition from preclinical development to clinical execution.
- Define the IND/CTA-enabling strategy, including key studies, regulatory milestones, quality requirements, external vendor needs, timelines, budgets, and critical path risks.
- Coordinate activities across internal stakeholders and external partners to ensure alignment on program objectives.
- Identify development risks and proactively implement mitigation strategies.
- Prepare project updates, development reports, and

📌 Director Preclinical (Barcelona)
🏢 ONA Therapeutics
📍 Barcelona