Drug Development Director

This is a full-time, indefinite contract position based between Barcelona and Tarragona, with flexible working hours and the possibility of remote work. The successful candidate will join a multidisciplinary team and play a key role in the development of SUCCIPRO’s biologic therapy. 

Job Responsibilities: 

• Prepare and lead the drug development process from lead candidate selection through to IND submission and early-phase clinical trials.
• Design and oversee preclinical development plans, including pharmacology, toxicology, and safety studies in compliance with regulatory standards.
• Coordinate and manage GLP-compliant safety and toxicology studies, ensuring data integrity and adherence to timelines.
• Develop and implement regulatory strategies aligned with EMA/FDA guidelines to support successful IND/CTA submissions.
• Prepare, review, and submit regulatory documentation including Investigator’s Brochures, IND/CTA dossiers, and responses to regulatory agencies.
• Collaborate with CROs and CDMOs to ensure quality and compliance in outsourced activities, including manufacturing and analytical development.
• Supervise the production of clinical trial material under GLP/GMP conditions, ensuring traceability and documentation.
• Maintain up-to-date knowledge of regulatory requirements and proactively assess their impact on development plans.
• Work cross-functionally with internal teams (R&D, QA, Clinical) to ensure alignment and integration of development activities.
• Contribute to the design of early clinical trials, including protocol development and regulatory submissions.
• Ensure proper documentation and archiving of all development activities in accordance with Good Documentation Practices (GDP)

Qualifications: 

• PhD in Biochemistry or a related discipline is required.
• Previous experience in preclinical regulatory drug development is essential (+3 years)
• Experience in supervising and managing CROs and CDMOs contracts is highly valued.
• Fluent professional English is required.
• Proficient computer skills (normal user level).

We Offer: 

• A dynamic and collaborative work environment.
• Opportunities for professional development.
• Flexible working hours Possibility to work from home.
• Salary to be discussed according to the profile of the candidate