**Date**:5 Dec 2024

**Location**: SFEL - R&D SANT FELIU DE LLOBR, ES, ES - Spain

**Company**:Almirall

**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 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 befor