Senior Quantitative Clinical Pharmacology Lead -M/F
Company: Pierre Fabre Laboratories
- Location: Toulouse, France
- Seniority: Mid level
- Employment type: Full-time
- Posted: 6 days ago
- Offer language: English
Job description
Join our mission to transform patient care through quantitative medicine within a pioneering company in full expansion.
We are seeking a highly skilled and motivated Senior Quantitative Clinical Pharmacology Lead to join our Clinical Pharmacology and Translational PK/PD team within the PK/PD and toxicology department at Pierre Fabre R&D Pharma in Toulouse (Langlade site, Oncopole, France).
In this high-impact strategic role, you will bridge the continuum between early translational pre-IND activities and late-stage regulatory and clinical successes. You will leverage deep clinical pharmacology expertise with an advanced understanding of Model-Informed Drug Development (MIDD) to drive data-driven decision-making, deliver efficacious therapies, and maximize the potential of our pipeline, focusing heavily on oncology, with expanding opportunities in rare disease and dermatology.
Your role within a pioneering company in full expansion:
- Strategic Matrix Leadership: Serve as the core Clinical Pharmacology and translational PK/PD Function Lead on cross-functional matrix asset teams. Collaborate closely with Toxicology, Clinical Development, Translational Medicine, Biostatistics, CMC, and Regulatory Affairs to steer program strategies. Lead and execute the clinical pharmacology development plans from pre-IND through approval and life-cycle innovation.
- MIDD Strategy & Oversight: Drive the Model-Informed Drug Development (MIDD) strategy for asset teams. Translate program needs into actionable modeling plans, closely collaborating with the internal quantitative modellers and / or external Contract Research Organizations (CROs) to deliver high-quality MIDD analyses (including PopPK, PK/PD, exposure-response, PBPK, TGI-OS, and MBMA).
- Therapeutic Expertise Application: Apply deep clinical pharmacology principles to address complex challenges unique to oncology (e.g., dose-optimization paradigms, combinations), rare disease (e.g., small sample sizes, innovative trial designs), and dermatology.
- Trial Design & Execution: Lead the clinical pharmacology design of first-in-human and dedicated clinical pharmacology trials. Provide expert scientific oversight for protocols, investigator brochures, and clinical study reports.
- Regulatory Interaction: Author and review high-quality clinical pharmacology sections for global regulatory interactions (IND, NDA, BLA briefings) and serve as the functional expert in meetings with health authorities.
- Business Development Opportunities: Conduct rigorous clinical pharmacology and quantitative due diligence on external business development opportunities, assessing the quality of the evidence, MIDD strategy, and clinical viability of assets of interest, in the context of the competitors landscape.
Your skills at the service of innovative projects:
- Education: Ph.D., Pharm.D., or M.D. in Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, or a highly quantitative biomedical field.
- Experience: 5+ years of pharmaceutical or biotech industry experience within clinical pharmacology and translational PK/PD.
- Therapeutic Track Record: Proven experience driving clinical pharmacology strategies in oncology is highly preferred; additional experience in rare diseases or immunology/dermatology is a distinct advantage.
- Advanced MIDD Literacy & Management: Modeling literacy with the ability to conceptualize, interpret, and defend quantitative strategies (e.g., PopPK, E-R, QSP). Demonstrated experience managing internal modellers and managing external vendors/CROs is highly desirable.
- Modality Versatility: Expertise in the development of small molecules and biologics is highly desirable; experience with advanced or emerging modalities is a distinct advantage.
- Leadership & Communication: Outstanding written and verbal communication skills with a proven track record of translating complex quantitative concepts to non-modeling stakeholders and influencing strategic decisions in matrix environments.
What We Offer
- A dynamic, science-first culture dedicated to oncology and precision therapeutic, and the opportunity to lead strategies across diverse modalities and indications.
- Competitive 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...
- This position is compatible with teleworking up to 2 days a week according to company rules.
Ready to lead the future of Model-Informed Drug Development at Pierre Fabre? Apply today!