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 (briefing documents, IND, CTA, NDA).
- Prepare and independently contribute sections for clinical protocols, Investigator Brochures, and Clinical Study Reports for clinical pharmacology studies/data.
- Partner closely with Research, Bioanalytical, Clinical, Regulatory, Project Management, and other R&D functions.
- Prepare abstracts and manuscripts for publications.
- Network with external expert consultants, CRO partners, and academic sites to solve clinical pharmacology issues.

Qualifications:
- Ph.D. (or Pharm.D.) in a relevant field (Pharmacokinetics, Pharmacometrics, Clinical Pharmacology) with at least 5 years’ experience in the 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/data visualization software.
- Ability to function in a highly matrixed environment and work independently.
- Strong verbal and written communication/presentation and interpersonal skills.
- Fluency in English (verbal and written).