Senior Principal Scientist – Project Toxicologist

This is a fully remote position, open to applicants in Belgium.

📋 Description

• Assist in the development of client compounds from lead optimization through to marketing submission and beyond.

• Create nonclinical safety strategies in collaboration with key stakeholders and present concepts and results to project teams and senior management.

• Engage and collaborate effectively with external CRO partners.

• Oversee nonclinical safety studies directly or in conjunction with study monitors and operational specialists.

• Write and review regulatory documents.

• Provide strategic advice regarding nonclinical safety screening and testing approaches.

• Contribute scientific knowledge to PharmTox discussions, program evaluations, and study designs across various modalities.

• Monitor outsourced activities and work alongside partner-company experts.

• Design nonclinical safety packages to support clinical programs and provide guidance on interactions with Health Authorities.

• Advise study monitors and toxicology teams on the implementation of strategies and execution and closure of studies.

• Ensure compliant study execution and coordinate contributions from sponsor disciplines, including CMC, Bioanalytics, and Pharmacokinetics.

• Analyze study results and present findings to multidisciplinary project teams and management forums.

• Contribute to the development strategy and present PharmTox responsibilities and deliverables during project and clinical team meetings.

• Collaborate with medical writing and regulatory affairs teams to prepare regulatory dossiers and investigator brochures.

• Ensure the nonclinical safety content is accurate and comprehensive.

• Assist with financial and project planning in collaboration with the program manager.

• Supervise the timely commissioning of studies to CROs and take part in vendor alliance governance meetings.

⛳️ Requirements

• Ph.D. in toxicology or equivalent experience.

• Minimum of 10 years of industry experience in a relevant role.

• Strong understanding of nonclinical development for peptide drugs and small molecules.

• Familiarity with the nonclinical development of biotherapeutics is advantageous.

• Thorough knowledge of GLP and ICH regulatory standards.

• Experience managing outsourced activities.

• Excellent interpersonal skills; enjoys working within multidisciplinary teams.

• Proactive and adaptable, capable of functioning in a dynamic environment of a rapidly growing biotech company.

• English is the working language.

🏝️ Benefits

• Full-time benefits.

• Opportunity to work in a client-focused role supporting a pioneering and fast-growing biotechnology organization.

• Chance to play a crucial role in nonclinical development programs and collaborate closely with multidisciplinary scientific teams.

• Highly collaborative environment with opportunities to contribute expertise, take ownership of key activities, and share in the success of development programs.