Senior Director/Director in Nonclinical Development

• Collaborate with program teams to design and execute integrated nonclinical safety strategies
• Drive the design of in vivo and in vitro studies to identify and mitigate test item-related toxicities
• Be a core/asset team member and be responsible for the nonclinical subteam in development projects
• Establish and manage strategic partnerships with CROs and provide oversight of outsourced studies
• Manage finalization of nonclinical study reports and other sub-vendor reports
• Prepare toxicological risk assessments to support drug development and manufacturing
• Support regulatory submissions and interactions with various agencies
• Work independently and collaboratively in a fast-paced environment

• Master’s degree within relevant field of expertise e.g. toxicology, veterinary medicine, pharmacology
• 10+ years of experience in technical, scientific, and regulatory aspects of nonclinical safety/toxicology evaluation
• Experience in developing nonclinical safety/toxicology programs to support various modalities from early to late-stage drug development
• Experience interfacing with, and providing scientific guidance to CRO partners
• Ability to prepare relevant sections of regulatory filings such as INDs/CTAs
• Proven success in supporting cross-functional project teams

PhD and other certifications are highly preferred

• Make a meaningful difference for patients with serious and underserved conditions
• Work in a collaborative, trust-based culture with a strong scientific focus and team spirit
• Be part of a growing international biotech with high ambitions