
PK PD Project Manager- Senior Pharmacokinetics Pharmacodynamics Scientist (M/F) - CDI
- Haute-Garonne
- CDI
- Temps-plein
- Strategic Leadership: Define PKPD needs across all development stages—from early preclinical to First-in-Human—ensuring alignment on study design, timelines, and budgets.
- Study Oversight: Lead or coordinate in vitro, in vivo, and in silico PK/PKPD studies, whether conducted in-house or outsourced, ensuring scientific rigor and operational excellence.
- Asset Evaluation: Provide expert PKPD assessments of external assets, contributing to strategic decision-making in licensing or acquisition.
- Cross-Functional Collaboration: Work closely with clinicians, statisticians, pharmacologists, toxicologists, and regulatory experts to drive project success.
- Scientific Documentation: Author key sections of regulatory and scientific documents, including study protocols, Investigator’s Brochures (IB), IND/IMPDs, NDAs, PIPs, and Risk Management Plans.
- Global Engagement: Represent the PKPD function in interactions with regulatory bodies, CROs, key opinion leaders, and business partners.
- Proven experience in PKPD within drug development, ideally in an international setting.
- Strong scientific acumen and ability to translate complex data into actionable insights.
- Excellent communication skills and a collaborative mindset.
- At least 5 year industry experience in a multicultural English speaking environment, with a solid track record in PK/PKPD drug development
- Practical knowledge and experience of PK/PKPD preclinical and clinical trial design and execution, including data collection, analysis and reporting approaches + filling of regulatory dossiers.
- Previous experience (hands-on) interpretation of PK and PKPD data, with in-silico methods.
- Significant track record with early drug development phases or moving candidate drugs to the clinic.