Associate Director, Clinical Pharmacology

Role Summary

Associate Director, Clinical Pharmacology responsible for supporting a rapidly expanding clinical portfolio of RNAi therapeutics, with expertise in clinical pharmacology, PK/PD, data analysis, and strong communication in a matrixed environment.

Responsibilities

• Represent independently 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 such as briefing documents, IND, CTA and NDA.
• Prepare and input independently appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data.
• Closely partner with Research, Bioanalytical, Clinical, Regulatory, Project Management, and other R&D functions.
• Preparation of abstracts and manuscripts for publications.
• Network with external expert consultants, CRO partners and academic sites to problem solve and develop scientific solutions to clinical pharmacology issues.

Qualifications

• Ph.D. (or Pharm.D.) in relevant field (i.e. Pharmacokinetics, Pharmacometrics, Clinical Pharmacology) with at least 5 years’ experience in 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 using Phoenix WinNonlin, R, NONMEM, or other pharmacokinetic, modeling and data visualizations software.
• Ability to function in a highly matrixed team environment; ability to work independently.
• Strong communication and presentation skills (verbal and written).
• Excellent interpersonal skills and ability to work independently.
• Fluency in English (verbal and written).

Skills

• Clinical pharmacology expertise
• PK/PD analysis and modeling
• Data interpretation and reporting
• Regulatory submission support
• Cross-functional collaboration

Education

• Ph.D. or Pharm.D. in Pharmacokinetics, Pharmacometrics, Clinical Pharmacology, or related field.