Senior Quantitative Clinical Pharmacology Lead (CDI)

About the role

Pierre Fabre Laboratories is looking for a Senior Quantitative Clinical Pharmacology Lead to join its Pharmacokinetics and Toxicology team in the R&D Pharma unit in Toulouse (Langlade site, Oncopole). The role bridges early translational pre-IND work and late-stage regulatory and clinical success, using clinical pharmacology expertise and Model-Informed Drug Development (MIDD) to drive data-driven decisions, with a strong focus on oncology and growing opportunities in rare disease and dermatology.

Key responsibilities

• Serve as the core Clinical Pharmacology and translational PK/PD function lead on cross-functional matrix teams, working with Toxicology, Clinical Development, Translational Medicine, Biostatistics, CMC and Regulatory Affairs to steer program strategies and run clinical pharmacology plans from pre-IND through approval and life-cycle innovation.
• Drive the MIDD strategy for asset teams, turning program needs into modeling plans with internal modellers and/or external CROs, delivering PopPK, PK/PD, exposure-response, PBPK, TGI-OS and MBMA analyses.
• Apply clinical pharmacology principles to oncology, rare disease and dermatology challenges such as dose optimization, combinations and small-sample trial designs.
• Lead the clinical pharmacology design of first-in-human and dedicated clinical pharmacology trials, overseeing protocols, investigator brochures and clinical study reports.
• Author and review clinical pharmacology sections for IND, NDA and BLA briefings and act as functional expert in health authority meetings.
• Carry out clinical pharmacology and quantitative due diligence on external business development opportunities, assessing evidence quality, MIDD strategy and clinical viability.

Required profile

• Ph.D., Pharm.D. or M.D. in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences or a highly quantitative biomedical field.
• 5+ years of pharmaceutical or biotech experience in clinical pharmacology and translational PK/PD.
• Proven track record driving clinical pharmacology strategies in oncology is highly preferred; rare disease, immunology or dermatology experience is an advantage.
• Expertise in small molecules and biologics, and experience with advanced or emerging modalities, is highly desirable.

Required skills

• Advanced MIDD literacy: PopPK, exposure-response, QSP, and the ability to manage internal modellers and external vendors/CROs.
• Outstanding written and verbal communication, able to explain quantitative concepts to non-modeling stakeholders and influence strategy in matrix environments.

What we offer

• A science-first culture focused on oncology and precision therapeutics, leading strategies across modalities and indications.
• Competitive remuneration and benefits: incentives, profit-sharing, shareholding with matching contribution, health and provident insurance, 16 days of RTT plus 25 days of personal leave, and public transport participation.
• Teleworking up to 2 days a week according to company rules.