Qui sommes-nous ? Pierre Fabre est le 2ème laboratoire dermo-cosmétique mondial, le 2ème groupe pharmaceutique privé français et le leader des produits vendus hors prescription dans les pharmacies en France. Son portefeuille compte plusieurs franchises médicales et marques internationales dont Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive et Pierre Fabre Oral Care. Implanté depuis toujours en région Occitanie, fabricant plus de 95% de ses produits en France, le groupe emploie près de 10 000 collaborateurs dans le monde et distribue ses produits dans quelque 130 pays. Pierre Fabre est détenu à 86% par la Fondation Pierre Fabre, une fondation reconnue dutilité publique, et secondairement par ses collaborateurs à travers un plan dactionnariat salarié. En 2021, Ecocert Environnement a évalué la démarche de responsabilité sociétale et environnementale du Groupe selon la norme ISO 26000 du développement durable et lui a attribué le niveau Excellence . Pierre Fabre est reconnu comme lun des Meilleurs Employeurs du Monde 2021 par Forbes. Notre groupe est classé dans le Top 6 de lindustrie cosmétique et dans le Top 7 de lindustrie pharmaceutique dans le monde. Nous sommes convaincus que notre engagement et notre passion font préserver notre indépendance et vivre notre raison d'être. Votre mission We are seeking a Clinical Study Monitor (PKPD & Biomarkers Focus) to support Clinical Pharmacology and Biomarker Experts in the design, execution, and analysis of clinical studies within the R& D team at Pierre Fabre Medical Care in Toulouse (Langlade site, Oncopole). This role ensures high-quality operational oversight of PK, PD, and biomarker components within early and late phase clinical trials, while contributing to regulatory documentation, study governance, sample management, and data integrity. Your role within a pioneering company in full expansion: Key Responsibilities 1. Study Design & Operational Support * Participate in the design, planning, and implementation of clinical studies in close collaboration with Clinical Pharmacology, Biomarker, and Clinical Operations teams. * Provide operational and scientific support for PK/PD and biomarker strategies throughout the study lifecycle. * Coordinate with internal and external stakeholders to ensure appropriate bioanalytical and biomarker resources are in place. 2. Sample & Bioanalysis Oversight * Oversee the Clinical CRO in charge of the end-to-end sample management oversight process (collection, handling, logistics, storage, and shipment). * Ensure timely and compliant execution of bioanalysis activities, both internal or outsourced. * Monitor the quality, timelines, and adherence to study plans for all PK/PD and biomarker analyses. 3. Documentation & Regulatory Support * Ensure documentation accuracy, completeness, and proper maintenance in RIM and related electronic systems. * Maintain oversight of studyrelated documentation, version control, and compliance with internal processes and regulatory expectations. 4. Data Management & Analysis Coordination * Support the management, cleaning, and validation of PK, PD, and biomarker datasets. * Coordinate with data management, statisticians, and clinical pharmacologists to ensure robust and timely analyses. * Ensure the drafting, review, or monitoring of PK/PD reports and PK/PD sections of clinical study reports (CSR). * Oversee outsourced analyses or reporting activities performed by CROs or external partners. 5. Study Budget, Planning & Vendor Oversight * Ensure accurate budget tracking and forecasting for PK/PD and bioanalytical activities within clinical studies. * Manage operational timelines and task planning for internal and external PK/PD and biomarker deliverables. * Support vendor selection, contracting, and performance oversight (CROs, central labs, bioanalytical labs). This position is compatible with teleworking up to 2 days a week according to company rules. We offer an attractive remuneration/benefits package: Incentives, profit-sharing, Pierre Fabre shareholding with matching contribution, health and provident insurance, 16 days of holidays (RTT) in addition to 25 days of personal holidays, public transport participation... Qui êtes-vous ? Your skills at the service of innovative projects: Education * Masters degree or equivalent in Life Sciences, Pharmacy, Biology, Biomedical Sciences, or related field. A PhD is a plus but not required. Experience * Experience in clinical study conduct, clinical operations, clinical pharmacology, or biomarker operations. * Good understanding of GCP, sample management workflows, and bioanalytical processes. * Experience with regulatory documentation and clinical trial governance is an advantage. * Prior interaction with CROs and external laboratories strongly preferred. Technical & Professional Skills * Basic understanding of PK/PD princ...