Senior Clinical Pharmacologist -M/F

Pierre Fabre Laboratories; Toulouse; Sur place; EUR 100 000 - 150 000; Plein temps

Avantages offerts par ce poste

Profit-sharing

Shareholding with matching

Health insurance

Provident insurance

RTT holidays

Public transport support

Résumé du poste

Pierre Fabre Laboratories in Toulouse is seeking a Senior Clinical Pharmacologist to join the Pharmacokinetics and Toxicology team to support clinical programs in oncology, dermatology and rare diseases.

You will lead the clinical pharmacology strategy as the PK representative in multidisciplinary project teams, drive IND translational dose setting, define study needs, timelines and budgets for FIH and Ph2/3, and oversee study design, regulatory documents and CRO partnerships.

Qualifications

• PhD, MD, or PharmD in pharmacokinetics, pharmacometrics or related discipline with 4+ years of industry experience in clinical pharmacology and drug development.

Responsabilités

• 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).
• Oversee the design and execution of clinical and pharmacometric studies.
• Collaborate with clinicians, statisticians, pharmacologists, toxicologists, CMC experts, and regulatory specialists.
• Partner with CROs, KOLs, and business partners to ensure successful study outcomes.

Connaissances

PK/PD study design

Clinical pharmacology

IND phase planning

Regulatory strategy

Cross-functional collaboration

English communication

Formation

PhD, MD, or PharmD in pharmacokinetics or related field

Outils

WinNonlin

NONMEM

GastroPlus

SimCYP

R

Description du poste

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.
• 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).