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 ResponsibilitiesToxicology 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.EducationGraduate 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 KnowledgeThis 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.#J-18808-Ljbffr