Senior Clinical Pharmacologist- CDI- H/F

Pierre Fabre Pharmaceuticals Inc.; Toulouse; Sur place; EUR 90 000 - 150 000; Plein temps

Avantages offerts par ce poste

Health insurance

Profit-sharing

16 additional holidays

Public transport participation

Provident insurance

16 RTT holidays

25 personal holidays

Public transport subsidy

Résumé du poste

A leading pharmaceutical company in Toulouse seeks a Senior Clinical Pharmacologist to support clinical programs in oncology, dermatology, and rare diseases. Responsibilities include leading clinical pharmacology strategy, overseeing studies, and authoring regulatory documents. The ideal candidate holds a PhD, MD, or PharmD with 4+ years of experience and expertise in PK/PD study design. The position allows for teleworking up to 2 days per week and offers competitive benefits.

Qualifications

• Minimum 4+ years of industry experience in clinical pharmacology and drug development.
• Proven track record of supporting drug development from early clinical phases.
• Strong understanding of EU and US regulatory requirements related to the IND phase.
• Proficiency in pharmacometric software and regulatory interactions.

Responsabilités

• Lead the clinical pharmacology strategy as the PK representative in multidisciplinary project teams.
• Oversee the design and execution of clinical and pharmacometric studies.
• Author scientific and regulatory documents, including study protocols and IND submissions.
• Collaborate with clinicians, statisticians, toxicologists, and regulatory experts; manage CROs and external partners.

Connaissances

Clinical pharmacology

Analytical thinking

Problem solving

Communication skills

English communication

Formation

PhD, MD, or PharmD in pharmacokinetics or related field

Outils

WinNonlin

NONMEM

GastroPlus

SimCYP

R

Description du poste

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 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 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 Group’s 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 "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.# ****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.*