Senior Clinical Pharmacologist

Senior Clinical Pharmacologist

Pierre Fabre

Haute-Garonne or Hauts-de-Seine, France

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.

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).