Principal Toxicologist

Almirall Hermal GmbH; Madrid; Presencial; EUR 70.000 - 100.000; Jornada completa

Descripción de la vacante

A leading company in the pharmaceutical industry is seeking a Toxicology Lead to drive non-clinical safety strategies and manage preclinical projects. The ideal candidate will possess a graduate degree in Toxicology and extensive experience in regulatory compliance and project management. This role emphasizes leadership, strategic thinking, and collaboration across teams to ensure high-quality outcomes in drug discovery.

Formación

• At least 10 years of experience in toxicology or related field.
• Significant experience leading preclinical projects.
• Extensive experience with regulatory submissions and data analysis.

Responsabilidades

• Lead development and execution of non-clinical safety strategies.
• Oversee toxicology studies and manage preclinical projects.
• Mentor junior scientists and conduct risk assessments.

Conocimientos

Leadership

Analytical Skills

Communication

Planning and Organization

Networking

Proactive Problem-Solving

Multi-Disciplinary Experience

Educación

Graduate Degree in Toxicology, Pharmacology, Chemistry, or Life Sciences

PhD in Toxicology or related discipline

Descripción del empleo

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Mission 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.

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