Your mission
We are seeking a Senior Clinical Pharmacologist to join the Pharmacokinetics and Toxicology team within the Pierre Fabre R&D Pharma in Toulouse to support clinical programs in oncology, dermatology and rare diseases (Langlade site, Oncopole, France).
Your role within a pioneering company in full expansion:
Project Leadership & Strategy
- Lead the clinical pharmacology strategy as the PK representative in multidisciplinary project teams.
- Lead the IND phase including translational dose setting
- Define study needs, timelines, and budgets for key development phases (e.g., FIH , Ph2/3, NDA submissions).
- Contribute to the evaluation of external assets, offering expert opinions to support business decisions.
Scientific & Operational Expertise
- Oversee the design and execution of clinical and pharmacometric studies.
- Oversee the design and execution of preclinical studies during the IND phase
- Collaborate closely with clinicians, statisticians, pharmacologists, toxicologists, CMC experts, and regulatory specialists.
- Partner with CROs, KOLs, and business partners to ensure successful study outcomes.
Documentation & Regulatory Interactions
- Author scientific and regulatory documents, including study protocols, investigator brochures (IB), IND/IMPD, NDA submissions, and risk management plans (RMPs).
- Represent the company in meetings with regulatory authorities, technical experts, and external stakeholders.
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:
PhD, MD, or PharmD in pharmacokinetics, pharmacometrics, or a related scientific discipline with a minimum of 4+ years of industry experience in clinical pharmacology and drug development,
• Proven track record of supporting drug development from early clinical phases (Ph1 /2/3) through regulatory submissions, preferably in oncology, dermatology or rare diseases.
Expertise:
• In-depth knowledge of PK/PD study design, analysis, and interpretation (NCA, PBPK, PopPK, modeling).
• Proficiency in pharmacometric software (e.g., WinNonlin, NONMEM, GastroPlus, SimCYP, R).
• Strong understanding of EU and US regulatory requirements related to the IND phase and clinical pharmacology.
Skills & Competencies:
• Strong analytical thinking and problem-solving skills.
• Ability to collaborate effectively within cross-functional teams and build productive external relationships.
• Excellent communication skills, both written and spoken, in English (French is a plus).