Requirements: English
Company: Almirall
Region: Sant Feliu de Llobregat , Catalunya
Mission
Identify a drug with an acceptable safety profile in humans that is appropriate for the intended population (e.g. therapeutic indication).
- 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.
- 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
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 challe