Senior Clinical Project Manager

Company name: ONA Therapeutics

Job location: Barcelona, Catalonia, Spain (On site)

Company Description

Ona Therapeutics is a clinical stage 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 for advanced cancer patients, to provide effective new treatments for patients with no remaining alternatives.

We are looking for:

We are seeking an experienced Senior Clinical Project Manager with a strong background in early-phase oncology and biological compounds, such as monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs). The ideal candidate will have significant experience in a biotech setting, demonstrating the ability to operate within small and agile teams.

Key responsibilities:

• Lead clinical CRO and vendor selection processes
• Responsible for initiation, execution, oversight and closure of ONA clinical trials within budget and timelines
• Manage CROs and other vendors to ensure adherence to trial protocols, including PK/PD, data management, statistics, medical writing, regulatory affairs, clinical supplies, pharmacovigilance.
• Primary contact for CROs, other vendors and clinical sites for operational execution of the trials and leading the contract negotiations with these external parties
• Oversee clinical trial site selection and initiation
• Participate in the development of clinical trial protocols, case report forms, and informed consent documents.
• Monitor and optimize clinical supply availabilities and patient recruitment
• Monitor clinical trial budget and ensure financial compliance.
• Ensure compliance with ICH, SOPs, local regulations, and applicable guidelines.
• Support CRO in conducting site monitoring visits to ensure data quality and integrity.
• Participate in risk management and contingency planning.
• Support the CMO in preparing scientific materials related to the company’s product portfolio.
• Collaborate in the development and documentation of Standard Operating Procedures (SOPs)

Candidate requirements:

Must have:

• Master’s or PhD degree in oncology setting
• Master’s degree in clinical trial management highly valued
• >8 years of experience in clinical operations, managing CROs and vendors
• Experience in working on the sponsor, ideally for a small company.
• Strong clinical operations background.
• Extensive knowledge of GCP and clinical trial processes.
• Ability to work in a high-pressure, deadline-driven environment.
• Excellent communication and reporting capabilities.
• Strong project management skills with methodical, organized, and meticulous practices.
• Strong cooperative team player, ability to be flexible
• Fluency in English and Spanish.

What we offer:

• A work environment, culture and passionate team focusing on unravel novel biology to design biopharmaceuticals attacking advanced cancer organization.
• A unique opportunity to work in an innovative and dynamic environment.
• A competitive salary package matching with the qualifications and experience of the candidate

To apply, please click on the following link: I want to apply for this position.

We look forward to reviewing your application and discovering how your skills and experience align with our company’s needs.