Associate Director, Clinical Pharmacology

Role Summary

Associate Director, Clinical Pharmacology. Support a rapidly expanding clinical portfolio of RNAi therapeutics with strong expertise in clinical pharmacology, PK and PD. Ability to critically evaluate data, conduct analyses, and communicate findings effectively in a highly matrixed environment.

Responsibilities

• Represent and provide independent clinical pharmacology support to clinical stage project teams.
• Lead 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 contribute to clinical protocols, Investigator Brochures, and Clinical Study Reports for Clinical Pharmacology studies or data.
• Collaborate closely with Research, Bioanalytical, Clinical, Regulatory, Project Management, and other R&D functions.
• Prepare abstracts and manuscripts for publications.
• Engage with external 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‚Äô experience in the pharmaceutical/biotech industry.
• In-depth knowledge of clinical pharmacology, pharmacokinetics, modeling and simulation, PK/PD, ADME, and clinical data interpretation.
• In-depth knowledge of international guidelines related to Clinical Pharmacology and Pharmacometrics.
• Proficiency in Phoenix WinNonlin, R, NONMEM, or other pharmacokinetic, modeling, and data visualization software.
• Ability to function effectively in a highly matrixed team environment and to work independently.
• Strong communication and presentation skills (verbal and written).
• Excellent interpersonal skills and fluency in English.