Director, DMPK - Massachusetts, United States - H&P Executive Search

Description

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).