Associate Director, Clinical Pharmacology

Responsibilities:
- Independently represent Clinical Pharmacology and provide Clinical Pharmacology support and guidance to clinical stage project teams.
- Lead the analysis, interpretation, integration, and reporting of clinical pharmacology data.
- Conduct PK and PK/PD analyses to guide clinical development decisions.
- Provide Clinical Pharmacology input for regulatory submissions (e.g., briefing documents, IND, CTA, NDA).
- Prepare and input appropriate documents/sections of clinical protocols, Investigator Brochures, and Clinical Study Reports for Clinical Pharmacology studies or data.
- Closely partner with Research, Bioanalytical, Clinical, Regulatory, Project Management, and other R&D functions.
- Prepare abstracts and manuscripts for publications.
- Network with external experts, CRO partners, and academic sites to resolve clinical pharmacology issues.

Qualifications:
- Ph.D. (or Pharm.D.) in a relevant field (e.g., Pharmacokinetics, Pharmacometrics, Clinical Pharmacology) with at least 5 years’ experience in a pharmaceutical/biotech industry.
- In-depth knowledge of clinical pharmacology, pharmacokinetics, modeling and simulation, PK/PD principles, ADME, and clinical data interpretation.
- In-depth knowledge of international guidelines related to Clinical Pharmacology and Pharmacometrics.
- Proficient in Phoenix WinNonlin, R, NONMEM, or other pharmacokinetic modeling and data visualization software.
- Ability to work independently and in a highly matrixed environment.
- Strong communication and presentation skills (verbal and written); excellent interpersonal skills.
- Fluency in English (verbal and written).