Associate Director, Clinical Pharmacology

Role Summary

The Associate Director in Clinical Pharmacology position will support a rapidly expanding clinical portfolio of promising RNAi therapeutics. The candidate in this position should be well versed in clinical pharmacology, PK and PD with strong ability to critically evaluate and interpret data and conduct data analysis. In this role, the candidate is expected to have a strong critical thinking ability with good oral and written communication skills as well as worked independently in a highly 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 atleast 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 is essential
• 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)