Principal Toxicologist

Mission

Identify a drug with an acceptable safety profile in humans that is appropriate for the intended population (e.g. therapeutic indication).

How -

• Guide Drug Discovery on selection of the best targets and compounds regarding safety up to candidate nomination
• Guide Drug Development on the safe progression of a drug up and through clinical testing and into routine clinical practice

Tasks and Responsibilities

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.

Key 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.
• Excellent Communication and Analytical Skills: Possesses outstanding communication abilities and strong analytical skills to interpret complex data.
• Strong Planning and Organizational Skills: Highly skilled in planning and organizing tasks to ensure efficient project management.
• Networking Capability: Capable of building and maintaining professional networks to support collaborative efforts.
• Multi-Disciplinary Experience: Proven track record of working successfully in complex, multi-disciplinary settings.
• High Proficiency in English: Fluent in both oral and written English, essential for effective communication and documentation.

Experience

• General Experience: At least 10 years of experience in toxicology, pharmacology, or a related field within the pharmaceutical or biotechnology industries.
• Leadership and Collaboration: Significant experience leading preclinical projects and working in cross-functional teams. 
• Regulatory and Analytical Skills: Extensive experience with regulatory submissions, data analysis, and risk assessments.
• Mentorship and Innovation: Proven track record of mentoring junior scientists and driving process improvements.

Values

• Care: We listen and empathize. We value diverse perspectives and backgrounds. We help each other succeed.
• Courage: We challenge the status quo. We take full ownership. We learn from our successes and failures. 
• Innovation: We put the patient and customer at the center. We create novel solutions. We empower entrepreneurial mindsets.
• Simplicity: We act decisively and avoid over-analysis. We understand why before we act. We are agile and keep things simple.