Mission
Lead the development and execution of non-clinical safety strategies throughout drug discovery, ensuring regulatory compliance and managing preclinical projects.
Oversee toxicology studies, collaborate with cross-functional teams and external partners to integrate toxicology data into project goals, and drive informed decision-making.
Mentor junior scientists, conduct risk assessments, and implement initiatives to improve efficiency and quality.
This role requires strong leadership, strategic thinking, and expertise in toxicology.
Tasks and Responsibilities Toxicology Strategy: Lead development of safety strategies from research to marketing, providing expert guidance. Toxicology Management: Manage preclinical projects, ensuring regulatory compliance and best practices. Cross-functional Collaboration: Work with teams and external partners to integrate toxicology data into project goals. Study Oversight: Oversee GLP and non-GLP toxicology studies by external labs and CROs, ensuring high quality, budget adherence, and timelines. Data Analysis & Reporting: Analyze data from studies, prepare reports, and communicate findings clearly. Target Safety Assessment: Lead safety assessments focusing on primary and off-target effects, reviewing biological functions and species variations. Risk Assessment: Evaluate potential side effects, conduct risk-benefit analyses, and balance risks with therapeutic benefits. Regulatory Compliance: Ensure adherence to global regulatory standards (e.g., FDA, EMA). Vendor Management: Select and evaluate external labs and CROs to ensure timely, high-quality study delivery. Mentoring: Guide junior scientists, fostering professional growth and a collaborative environment. External Asset Evaluation: Assess external non-clinical safety data and provide constructive feedback to improve safety profiles. Innovation & Initiatives: Lead projects to enhance group efficiency and quality, fostering continuous improvement. Education Graduate Degree: A graduate degree in Toxicology, Pharmacology, Chemistry, or Life Sciences is required. Doctorate: A PhD in Toxicology or a related discipline is highly desirable. Specialized Knowledge: In-depth knowledge of toxicology or a related field is essential. Regulatory Expertise: Comprehensive understanding of relevant regulatory guidelines and standards is crucial. Skills & Specific Knowledge This role requires a strategic thinker with strong leadership skills, a deep understanding of toxicology, and the ability to work collaboratively across various teams and disciplines.
Science-Driven and Independent: Demonstrates a strong scientific foundation and the ability to work independently, adapting effectively to changing environments. Proactive and Solution-Oriented: Exhibits a proactive approach, focusing on solutions and driven by performance.
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