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

 

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.

 

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. 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. 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.