Job Description

Who we are ?

Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world, the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies.

Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncologie, Pierre Fabre Dermatologie, Eau Thermale Avène, Klorane, Ducray, René Furterer, A-Derma, Naturactive, Pierre Fabre Oral Care.

Established in the Occitanie region since its creation, and manufacturing over 95% of its products in France, the Group employs some 10,000 people worldwide. Its products are distributed in about 130 countries. 86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation, a government-recognized public-interest foundation, while a smaller share is owned by its employees via an employee stock ownership plan.

In 2019, Ecocert Environment assessed the Group’s corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the “Excellence” level.

Pierre Fabre is recognized as one of the "World's Best Employers 2021" by Forbes. Our group is ranked in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide.

Your 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 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...

Who you are ?

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 Skills

• 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.

We are convinced that diversity is a source of fulfillment, social balance and complementarity for our employees, which is why our offers are open to all, without restriction.