Director Preclinical & Regulatory Development

Director Preclinical & Regulatory Development

Company name: ONA Therapeutics

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 governance materials for leadership teams.
• Contribute scientific, regulatory, and quality expertise to due diligence and partnering activities (in-licensing, out-licensing, business development).

Preclinical Development Management

• Define the non-clinical strategy (toxicology, pharmacokinetics, modelling, biomarkers) required to support candidate nomination and IND/CTA-enabling packages.
• Coordinate outsourced toxicology, pharmacokinetics, modelling, biomarker, and other non-clinical studies.
• Oversee day-to-day CRO and consultant relationships, study execution, timelines, budgets, and deliverables.
• Ensure study plans, reports, and data support regulatory requirements and development objectives.
• Track critical path activities leading to IND/CTA-enabling packages.
• Support interpretation and integration of non-clinical data into regulatory documentation.

CMC and Development Interface

• Partner closely with CMC leads, CDMOs, and external experts to ensure alignment between non-clinical, regulatory, quality, and manufacturing strategies.
• Ensure that CMC-related inputs required for regulatory submissions are appropriately integrated into IND/CTA packages, IMPD documentation, and health authority briefing materials.
• Support risk assessment of manufacturing, release testing, analytical methods, stability, comparability, supply readiness, and other CMC-related issues that may impact preclinical or early clinical development timelines.
• Contribute to cross-functional decision-making on development risks that may affect IND/CTA readiness or early clinical execution.

External Partnerships & Contract Management

• Build and maintain an optimized network of external development partners (CROs, consultants, laboratories, CDMOs) aligned with program needs, quality standards, and budget.
• Lead negotiation of contracts, statements of work, and change orders with CROs and consultants across tox, PK, regulatory, and quality activities.
• Ensure all outsourced work is covered by an appropriate signed agreement (CDA, MSA, SOW) before initiation; maintain oversight of contract status across the partner network.

Regulatory Affairs Strategy

• Define and drive the global regulatory strategy for ADC programs, from candidate nomination through IND/CTA filing and early clinical development.
• Coordinate preparation and submission of regulatory documentation, including Investigator's Brochure, IMPD, INDs, CTAs, briefing packages, annual reports, and responses to health authority questions.
• Manage day-to-day relationships with external regulatory consultants and ensure timely delivery of regulatory documents and submission components.
• Support interactions with regulatory authorities and preparation for scientific advice meetings.
• Monitor evolving regulatory requirements and assess potential impact on development programs.

Quality Management System

• Define the quality strategy and risk-based QMS framework appropriate for a development-stage biotech company; act as internal QMS owner.
• Promote a culture of quality throughout the organization.
• Support implementation and maintenance of SOPs, training records, document control, and vendor qualification processes.
• Coordinate audits and ensure quality oversight of outsourced activities performed by CROs, CDMOs, laboratories, and consultants.
• Support inspection readiness and regulatory compliance activities.
• Collaborate with external quality consultants to maintain GxP compliance.

Clinical Transition Support

• Collaborate closely with Clinical Operations and Chief Medical Officer to ensure a smooth transition from preclinical development into clinical execution.
• Support operational readiness for first-in-human studies.
• Coordinate transfer of regulatory, quality, and non-clinical documentation to clinical teams.
• Support activities through early clinical proof of concept.

Qualifications and Skills Requirements

• PhD in Pharmacology, Toxicology, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline.
• Minimum of 5 years of experience in the biotechnology or pharmaceutical industry, with responsibility for preclinical development and/or regulatory affairs.
• Demonstrated experience supporting development programs from candidate nomination through first-in-human studies and early clinical proof of concept.
• Experience negotiating contracts and managing budgets with CROs, CDMOs, and external consultants.
• Working knowledge of global regulatory requirements, including IND/CTA submissions and non-clinical regulatory expectations.
• Familiarity with GxP regulations (GLP, GCP, GMP) and quality management systems within a development-stage biotech environment.
• Experience in project management of cross-functional drug development programs in oncology is strongly preferred.

Skills & Competencies

• Strong project and program management skills with the ability to manage multiple priorities simultaneously.
• Solid understanding of non-clinical drug development, toxicology, pharmacokinetics, regulatory affairs, and quality systems.
• Excellent organizational skills with strong attention to detail and the ability to manage complex timelines.
• Ability to identify risks proactively and implement practical mitigation strategies.
• Strong analytical and problem-solving capabilities.
• Excellent written and verbal communication skills, including preparation of scientific and regulatory documentation.
• Proven ability to work effectively in cross-functional, multidisciplinary teams and manage external partners, including contract negotiation.
• Business acumen, with experience contributing to due diligence or partnering activities considered a plus.
• Comfortable operating in a fast-paced, entrepreneurial biotech environment with changing priorities.
• High level of ownership, accountability, and initiative.
• Strong interpersonal and stakeholder management skills.
• Fluent in English, Spanish a plus

What we offer

• A work environment, culture and passionate team in the oncology sector.
• A unique opportunity to work in an innovative and dynamic environment.
• Internal benefits such as flexible remuneration, flexible working hours, events along the year...