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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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