Senior Clinical Pharmacologist
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• 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... 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).
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