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).