Senior Clinical Pharmacologist- CDI- H/F

INSTITUT DE RECHERCHE PIERRE FABRE SAS; Pechbusque; Sur place; EUR 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Incentives

Health insurance

16 days RTT holidays

25 days personal holidays

Public transport participation

Résumé du poste

INSTITUT DE RECHERCHE PIERRE FABRE SAS is hiring a Senior Clinical Pharmacologist to join the Pharmacokinetics and Toxicology team in Pechbusque, France. The successful candidate will lead clinical pharmacology strategies and oversee the execution of pharmacometric studies for oncology, dermatology, and rare diseases.

The ideal candidate holds a PhD, MD, or PharmD and has over 4 years of industry experience, including a strong understanding of drug development regulations. The position allows for teleworking up to 2 days a week.

Qualifications

• Minimum of 4+ years of industry experience in clinical pharmacology.
• Track record of supporting drug development through clinical phases.
• In-depth knowledge of PK/PD study design and interpretation.

Responsabilités

• Lead the clinical pharmacology strategy for multidisciplinary project teams.
• Oversee clinical and pharmacometric studies' design and execution.
• Author regulatory documents and represent the company in meetings.

Connaissances

Clinical pharmacology expertise

Pharmacokinetics knowledge

Drug development experience

Analytical thinking

Collaboration skills

Formation

PhD, MD, or PharmD in pharmacokinetics or related

Outils

WinNonlin

NONMEM

GastroPlus

SimCYP

R

Description du poste

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).

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, Phase2/3, 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.

Qualifications

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.
• 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).

Benefits

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.