Senior Clinical Pharmacologist -CDI

<h1><span><b><b>Who we are ?</b></b></span></h1><p></p><p>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.</p><p></p><p>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. </p><p><br/>Established in the Occitanie region since its creation, and manufacturing over 95% of its products in France, the Group employs some 10,000 people worldwide. Its products are distributed in about 130 countries. 86% of the Pierre Fabre Group is held by the Pierre Fabre Foundation, a <span><span><span><span><span><span>government-recognized</span></span></span></span></span></span> public-interest foundation, while a smaller share is owned by its employees via an employee stock ownership plan. </p><p><br/>In 2019, Ecocert Environment assessed the Group’s corporate social and environmental responsibility approach in accordance with the ISO 26000 sustainable development standard and awarded it the “Excellence” level.</p><p><br/>Pierre Fabre is recognized as one of the "World's 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. </p><p></p><p></p><p></p><p></p><h1><span><b><b>Your mission</b></b></span></h1><p></p><p>Pierre Fabre R&amp;D Medical Care is hiring a <b>Senior Clinical Pharmacologist</b> to join the PK/PD Group in Toulouse (site Langlade, Oncopole, France).</p><p></p><p><b><u>Your Key Responsibilities:</u></b></p><p></p><p><b>Project Leadership &amp; Strategy</b></p><ul><li>Lead the clinical pharmacology strategy as the PK representative in multidisciplinary project teams.</li><li>Define study needs, timelines, and budgets for key development phases (e.g., FIH , Ph2/3, NDA submissions).</li><li>Contribute to the evaluation of external assets, offering expert opinions to support business decisions.</li></ul><p></p><p><b>Scientific &amp; Operational Expertise</b></p><ul><li>Oversee the design and execution of clinical and pharmacometric studies.</li><li>Collaborate closely with clinicians, statisticians, pharmacologists, toxicologists, CMC experts, and regulatory specialists.</li><li>Partner with CROs, KOLs, and business partners to ensure successful study outcomes.</li></ul><p></p><p><b>Documentation &amp; Regulatory Interactions</b></p><ul><li>Author scientific and regulatory documents, including study protocols, investigator brochures (IB), IND/IMPD, NDA submissions, and risk management plans (RMPs).</li><li>Represent the company in meetings with regulatory authorities, technical experts, and external stakeholders.</li></ul><p> </p><p>This position is compatible with teleworking up to 2 days a week after the trial period.</p><p></p><p>We offer an attractive <span>remuneration/benefits</span> 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, very attractive CE...</p><p></p><p></p><p></p><p></p><p></p><h1></h1><h1><span><b><b>Who you are ?</b></b></span></h1><p></p><h1></h1><p><u><b>Education and Experience:</b></u></p><p> </p><p>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,<br/>•    Proven track record of supporting drug development from early clinical phases (Ph1  /2/3) through regulatory submissions, preferably in oncology, dermatology or rare disease.  </p><p><br/><u><b>Expertise:</b></u><br/>•    In-depth knowledge of PK/PD study design, analysis, and interpretation (NCA, PBPK, PopPK, modeling).    <br/>•    Proficiency in pharmacometric software (e.g., WinNonlin, NONMEM, GastroPlus, SimCYP, R).<br/>•    Strong understanding of EU and US regulatory requirements related to clinical pharmacology.</p><p><br/><u><b>Skills &amp; Competencies:</b></u><br/>•    Strong analytical thinking and problem-solving skills.<br/>•    Ability to collaborate effectively within cross-functional teams and build productive external relationships.<br/>•    Excellent communication skills, both written and spoken, in English (French is a plus).</p><p></p><p></p><p></p><p>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.</p>