Clinical Study Monitor (PK/PD & Biomarkers Focus)- CDI- F/M

Nous sommes les Laboratoires Pierre Fabre, leader mondial qui allie expertise pharmaceutique et dermo-cosmétique pour accompagner les consommateurs et les patients à chaque étape de leur parcours de soins. Notre portefeuille compte plusieurs franchises médicales et marques internationales dont Eau thermale Avène, Ducray, A-Derma, Klorane, René Furterer et Pierre Fabre Oral Care. En nous rejoignant, vous intégrez une entreprise riche de sens, où la dimension humaine est essentielle.

Vous devenez acteur du "We Care Movement", un mouvement qui valorise l'excellence et l'innovation au sein d'équipes passionnées. Ensemble, nous repoussons les limites de la science pour unir santé et beauté au bénéfice de tous, car à chaque fois que nous prenons soin d’une seule personne, nous rendons le monde meilleur. Présents dans 120 pays et une équipe de plus de 10 000 collaborateurs, nous sommes fiers de créer un impact scientifique et humain, aujourd'hui et demain!

Si prendre soin est au cœur de vos valeurs, rejoignez les Laboratoires Pierre Fabre et devenez un acteur clé du "We Care Movement". 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.

within a pioneering company in full expansion:

• 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 study‑related 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...

Your skills at the service of innovative projects: Education

• Master’s 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

Basic understanding of PK/PD principles and biomarker assays.

• Specialized training in NCA pharmacokinetic data analysis would be preferable. Proficiency of pharmacokinetic data analysis software (WNL) is a plus.
• Familiarity with clinical databases (EDC, LIMS) and document management systems (RIM or equivalent).
• Strong organizational skills with the ability to coordinate complex study activities.
• Excellent written and verbal communication skills in English; French is a plus. Behavioral Competencies
• Strong cross‑functional collaboration and stakeholder management.
• Proactive problem‑solving and attention to quality.
• Ability to drive timelines, anticipate risks, and maintain study oversight.
• Team‑oriented mindset and willingness to support scientific colleagues. La première richesse des Laboratoires Pierre Fabre, sont les femmes et les hommes qui les composent disait M. Pierre Fabre. Fiers de cet héritage, et convaincus que la diversité des parcours, des expériences et des identités renforce notre performance collective, nous nous engageons à promouvoir l’égalité des chances et à garantir un environnement inclusif pour tous. Dans le respect des lois en vigueur, toutes les candidatures sont étudiées avec la même attention, sans distinction d’origine, de sexe, d’âge, de situation de handicap, d’orientation sexuelle, d’identité de genre, de croyances ou de toute autre caractéristique protégée par la loi.