Senior Toxicologist M/FFamille de fonction : Développement clinique
Description du poste et des missions
Pierre Fabre Group is committed to Medical Care R&D to develop innovative therapeutics to serve unmet cancer patient needs.
The Department of Toxicology and Product Safety of Pierre Fabre Medicament is seeking a talented and highly motivated Senior Toxicologist to participate actively to drug discovery efforts and strategy, mainly in oncology.
In close collaboration with the research teams and project stakeholders you will de-risk and guide the selection and early development of candidate drugs from a toxicological perspective.
You have significant experience in evaluation of small molecules and biologics to support proactively candidate drug discovery from research to phase I clinical trials and to complete subsequent nonclinical development phases until registration.
The location of the position will be Toulouse, with high flexibility in terms of commuting from France/Europe and home office.
What you are expected to do:
1. Perform early target evaluations for toxicity prediction based on literature, analysis of pharmacological mode of action, transgenic animal models, already marketed molecules with similar mechanisms of action, translation in terms of toxicity and potential clinical adverse events.
2. As the non-clinical safety expert in the project core team, you propose experimental investigations in close collaboration with pharmacologist to refine risks, rank drug candidates or propose risk-mitigation measures from a toxicological perspective.
3. You will be the non-clinical safety expert in the project core team, in clinical study and safety teams as well as in meetings with authorities when relevant.
4. Define & monitor nonclinical development plans from the first in man step, until drug registration both for oncology and non-oncology indications, establish timelines, budget and ensure compliance with international applicable guidelines (FDA, ICH, EMA mainly).
5. Conduct in-depth analysis of toxicity study results, recommend additional investigations if necessary and communicate risks and findings to management and project teams.
6. You participate to the scientific evaluation of external opportunities in R&D.
7. Write nonclinical sections for IBs, IMPD, CTD, briefing packages, and provide toxicology regulatory support all along product development and beyond, represent the company for interactions with Agencies
- PhD/PharmD/DVM with speciality in toxicology & proven knowledge in pharmacology, immunology or pathology ideally with at least 10 years of experience as toxicologist in drug development.
- Strong background in toxicology applied to early drug discovery and drug development in the field of oncology, and immuno-oncology.
- Successful participations in drug discovery programs, including target validation, mechanistic assay development, functional screening, early safety assessment, de-risking and strategy in relation with pharmacological mechanisms.
- Previous experience in the biotech/pharma industry or in CRO for in vitro and / or in vivo toxicology studies with experience in study subcontracting and monitoring.
Your skills and competences:
You are an expert in toxicology applied to drug development with significant records in drug discovery mainly in oncology. A double experience with biologics and small molecules is preferable.
You have excellent knowledge in pharmacology/immunology applied to oncology.
You have excellent communication and team spirit to work within multi-disciplinary project teams.
You are fluent in English and French knowledge would be appreciated.
Lieu de la mission
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