Director, DMPK
About the Company :
They are a leading biotechnology company working on addressing the underlying cause of severe diseases
Director, DMPK Job Description :
We are seeking a highly skilled and motivated Director with a strong background with DMPK / Clinical Pharmacology within the biotechnology space.
They will provide implement strategies to support preclinical / clinical drug development.
Director, DMPK Key Responsibilities :
- Supervise the preparation, presentation, and interpretation of findings from clinical pharmacology studies and assess their impact on project outcomes.
- Coordinate the identification and management of external vendors offering PK and modeling services.
- Formulate a plan for clinical pharmacology and modeling & simulation to support the initial clinical development.
- Conduct an analysis of gaps in clinical pharmacology to inform the strategic advancement and devise strategies to address any identified deficiencies.
- Draft and oversee the DMPK / clinical pharmacology sections of regulatory communication documents, such as briefing documents for regulatory meetings, Investigator Brochures (IBs), Pediatric Investigational Plans (PIPs), and reports on population pharmacokinetics (popPK) modeling / simulation.
Director, DMPK Qualifications :
- Ph.D. in Pharmacology or a related field.
- A minimum of 12 years' experience including extensive industry experience in DMPK.
- Experience in Modeling & Simulations, DMPK and model informed drug development
- Experience examining and understanding preliminary clinical investigations, as well as ADME studies that underpin Phase 2 / Phase 3 trials.
- Extensive experience developing modeling strategy throughout the development.
Compensation for this position is competitive + package (commensurate to experience and background).
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