Associate Director, Clinical Pharmacology & PK Modeling

Xyzagen; United States; Remote; USD 120.000 - 156.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision insurance

401(k) with match

Company-paid holidays

2 weeks paid time off

Local onsite in Pittsboro, NC

Zusammenfassung

Xyzagen, a contract research lab, seeks an Associate Director of Clinical Pharmacology to lead design, execution, and interpretation of clinical pharmacology studies (Phase I–III) and to develop quantitative pharmacometric strategies for dose selection and regulatory submissions.

The role may involve small or large molecules, in vitro ADME for small molecules, and bioanalytical assay development for large molecules.

Qualifikationen

• Advanced degree in a relevant field with strong pharmacology foundation.
• 5–8 years of progressive clinical pharmacology or drug development experience.
• Deep understanding of regulatory guidelines and their application.
• Experience in PK/PD modeling and simulation software.

Aufgaben

• Lead design, execution, and interpretation of Phase I–III clinical pharmacology studies.
• Develop and implement quantitative pharmacometrics to support dose selection.
• Provide strategic regulatory consulting for INDs, NDAs, and related filings.
• Author and review pharmacology sections of regulatory documents.
• Translate complex pharmacometric data into actionable development strategies.
• Guide associate scientists and collaborate with cross-functional teams.
• Engage with clients and lead business development discussions.

Kenntnisse

Clinical pharmacology

Pharmacokinetics

Pharmacometric modeling

Regulatory knowledge (FDA/EMA/ICH)

Leadership & team management

Cross-functional collaboration

Ausbildung

MS/PhD/PharmD/MD in Clinical Pharmacology or related

Tools

Phoenix WinNonlin

NONMEM

R

Monolix

Jobbeschreibung

Xyzagen, a contract research lab, seeks an Associate Director of Clinical Pharmacology to lead design, execution, and interpretation of clinical pharmacology studies (Phase I–III) and to develop quantitative pharmacometric strategies for dose selection and regulatory submissions.

The role may involve small or large molecules, in vitro ADME for small molecules, and bioanalytical assay development for large molecules.