Pierre Fabre is the 2nd largest dermo-cosmetics laboratory in the world the 2nd largest private French pharmaceutical group and the market leader in France for products sold over the counter in pharmacies.

Its portfolio includes several medical franchises and international brands including Pierre Fabre Oncologie Pierre Fabre Dermatologie Eau Thermale Avène Klorane Ducray René Furterer A-Derma Naturactive Pierre Fabre Oral Care.

Established in the Occitanie region since its creation and manufacturing over 95% of its products in France the Group employs some 10000 people worldwide. Its products are distributed in about 130 countries.86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation a government-recognized public-interest foundation while a smaller share is owned by its employees via an employee stock ownership plan.

In 2019 Ecocert Environment assessed the Groups corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the Excellence level.

Pierre Fabre is recognized as one of the Worlds Best Employers 2021 by Forbes. Our group is ranked in the Top 3 in the cosmetics industry and in the Top 10 in the pharmaceutical industry worldwide.

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...

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).

We are convinced that diversity is a source of fulfillment social balance and complementarity for our employees which is why our offers are open to all without restriction.