Sr Principal Scientist (Project Toxicologist) - Client-dedicated

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting, Office Job Description 12-month fixed-term Job Opporutnity Fully Remote Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our clients to make the world healthier, safer, and cleaner. Within our Analytical Services team, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. We are seeking an experienced Sr Principal Scientist (Project Toxicologist) with expertise in the nonclinical development of multiple drug modalities, particularly pharmacologically active peptides and small molecules. Experience with large-molecule development is a plus. Ten or more years of relevant experience working within cross-functional project teams is preferred. This is a client-dedicated position, offering the opportunity to work closely with an innovative, rapidly growing biotechnology company while being part of Thermo Fisher Scientific's PPD clinical research business. Role Overview As a Sr Principal Scientist (Project Toxicologist) , you will support the development of the client's compounds from an early stage (lead optimization) through submission for marketing and beyond. Sr Principal Scientists (Project Toxicologists) are core members of early development teams and ad hoc members of asset teams. You will design nonclinical safety strategies in alignment with key stakeholders and present concepts and results to project teams and senior management. The client's studies are conducted in partnership with leading CROs, making effective interaction and collaboration with external partners a vital part of the role. Strong communication and stakeholder management skills are therefore essential. You may be supported by study monitors and operational specialists to ensure the smooth conduct of nonclinical safety studies or may monitor their own studies. You are also expected to contribute significantly to the authoring and review of regulatory documents. The client's PharmTox team is a functional expert group within the Development organization, with expertise in nonclinical safety testing and the operations of regulated studies. The team works closely with colleagues in nonclinical and clinical bioanalytics, as well as across other functional areas, and participates in multidisciplinary teams supporting discovery and development. The client operates an outsourcing model in which scientific and quality oversight from the sponsor is an important part of the work. The working language is English. Collaboration and co-creation are central to the client's way of working. Ghent, Belgium is an important research hub where many members of the toxicology (PharmTox) team are located. Regular in-person interactions play an important role in collaboration and driving project success. While this role can be performed remotely, the successful candidate will be expected to attend face-to-face meetings whenever feasible based on their location. Responsibilities Provide strategic guidance on nonclinical safety screening and testing strategies of candidate compounds Contribute scientific expertise to PharmTox discussions on programs, reviews, and study designs across multiple modalities, including large molecules and emerging therapeutic platforms. Follow outsourced activities and collaborate with experts at partner companies. Design a nonclinical safety package that enables and supports the clinical program, be a key contributor in the ambitions of the project team, obtain buy-in of all stakeholders and advise on interactions with Health Authorities to secure timely feedback. Closely work with and advise the client's study monitor and toxicology team on implementation of strategy, and execution and close out of studies. Ensure compliant execution of studies by study monitoring either in-person or with support of the study monitor. Coordinate contributions of other sponsor disciplines (CMC, Bioanalytics, Pharmacokinetics). Collaborate with other scientific disciplines to interpret the study outcomes and present at internal multidisciplinary project teams and management forums Contribute to development strategy in internal multidisciplinary project and clinical team meetings, and present and discuss PharmTox responsibilities and deliverables. Collaborate with medical writing and regulatory affairs teams in development of regulatory dossiers and the investigator brochure. Ensure nonclinical safety -related content is correct and comprehensive. In collaboration with the program manager, ensure correct financial and project planning. Together with Sourcing and program manager, oversee the timely commission of studies to CROs. Participate in vendor alliance governance meetings as appropriate. Required Skills and Experience Ph.D degree in toxicology or equivalent by experience At least 10 years of industry experience in a relevant position A solid understanding of nonclinical development of peptide drugs, and small molecules. Understanding of the nonclinical development of biotherapeutics is a plus. Excellent understanding of GLP and ICH regulatory requirements Experience in managing outsourced activities Excellent interpersonal skills; enjoys working in multidisciplinary teams Proactive and flexible, able to operate in a dynamic surrounding of a fast-growing biotech company What We Offer The opportunity to work in a client-dedicated role supporting an innovative and rapidly growing biotechnology organization. The opportunity to play an integral role in nonclinical development programs and work closely with multidisciplinary scientific teams. A highly collaborative environment where you can contribute your expertise, take ownership of key activities and share in the success of development programs. Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference. Our 4i Values: Integrity – Innovation – Intensity – Involvement If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you! Apply today to help us deliver tomorrow’s breakthrough.