Senior Director, Preclinical Development – Biologics Pipeline

The Senior Director, Preclinical Development will take full ownership of the preclinical development of multiple large-molecule programs, including the design, execution, and integration of pharmacology, translational biology, toxicology, and IND-enabling studies. This role will be a key member of the R&D organization and will work closely with internal teams, external partners, CROs, and global collaborators to advance programs into clinical development.

• Lead the overall preclinical development strategy for multiple biologics programs, ensuring scientific rigor, development efficiency, and alignment with clinical and regulatory objectives.
• Oversee non-clinical study planning and execution, including pharmacology, efficacy, mechanism-of-action studies, PK/PD, toxicology, safety pharmacology, and IND-enabling packages.
• Provide scientific and strategic leadership to support candidate selection, development planning, regulatory submissions, and clinical transition.
• Work cross-functionally with discovery biology, translational medicine, clinical development, CMC, regulatory affairs, and project management teams.
• Manage external CROs, academic collaborators, and international partners to ensure high-quality delivery of preclinical development activities.
• Contribute to regulatory strategy and preparation of key documents for IND/CTA submissions.
• Present development strategies, study results, risks, and recommendations to senior leadership and governance committees.
• Support the growth of an international R&D organization by promoting effective collaboration, scientific excellence, and clear communication across global teams.

• PhD degree in Neurobiology, Pharmacology, or a related life sciences discipline.
• Minimum of 10 years of relevant experience in the pharmaceutical or biotech industry.
• Deep expertise in large-molecule drug development, including antibodies, biologics, or related therapeutic modalities.
• Proven track record of leading large-molecule programs from preclinical development into clinical stage.
• Strong understanding of translational biology, pharmacology, toxicology, PK/PD, and regulatory requirements for biologics development.
• Experience working with CROs, external partners, and cross-functional development teams.
• Strong leadership skills with the ability to drive complex programs in a fast-paced biotech environment.
• Excellent verbal and written English communication skills.
• Demonstrated ability to work effectively in an international and multicultural team environment.

The ideal candidate is a scientifically strong and execution-oriented preclinical development leader with hands-on experience advancing biologics into the clinic. This person should be comfortable operating at both strategic and operational levels, capable of leading multiple programs simultaneously, and able to communicate effectively with senior management, technical teams, CROs, and global partners.