Senior Principal Scientist – Project Toxicologist

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🔥 0 minutes ago

🇧🇪 Belgium – Remote

⏰ Full Time

🟠 Senior

🧬 Research Scientist

👻 Ghost score 10%

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Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Support development of client compounds from lead optimization through marketing submission and beyond • Design nonclinical safety strategies with key stakeholders and present concepts and results to project teams and senior management • Interact and collaborate effectively with external CRO partners • Monitor nonclinical safety studies directly or with study monitors and operational specialists • Author and review regulatory documents • Provide strategic guidance on nonclinical safety screening and testing strategies • Contribute scientific expertise to PharmTox discussions, program reviews, and study designs across multiple modalities • Follow outsourced activities and collaborate with partner-company experts • Design nonclinical safety packages supporting clinical programs and advise on Health Authority interactions • Advise study monitors and toxicology teams on strategy implementation and study execution and closeout • Ensure compliant study execution and coordinate sponsor-discipline contributions including CMC, Bioanalytics, and Pharmacokinetics • Interpret study outcomes and present findings to multidisciplinary project teams and management forums • Contribute to development strategy and present PharmTox responsibilities and deliverables in project and clinical team meetings • Collaborate with medical writing and regulatory affairs teams on regulatory dossiers and investigator brochures • Ensure nonclinical safety content is correct and comprehensive • Support financial and project planning with the program manager • Oversee timely commissioning of studies to CROs and participate in vendor alliance governance meetings

🎯 Requirements

• Ph.D degree in toxicology or equivalent by experience • At least 10 years of industry experience in a relevant position • 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 • Working language is English

🏖️ Benefits

• Full-time benefits • Opportunity to work in a client-dedicated role supporting an innovative and rapidly growing biotechnology organization • Opportunity to play an integral role in nonclinical development programs and work 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

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