Hurley Consulting Associates is seeking a Pharmacokineticist to join our Scientific Affairs group. PhD with a minimum of 5 years’ pharmaceutical industry experience. The successful candidate must have excellent written and oral communication skills and have a working knowledge of US and global regulatory and compliance requirements (FDA, CFR, ICH, and OECD). Experience in WinNonlin required and PK/PD modeling a plus. The main focus of this position is to support the pharmacokinetic and metabolism assessment of small molecules and biologics in various stages of development.
The responsibilities include:
- Contribute to the preparation of regulatory submissions including INDs, NDAs, and BLAs which includes preparation of written and tabular pharmacokinetic and metabolism summaries
- Participate in cross-functional teams as a pharmacokinetics expert and provide support to others in the preparation, analysis, and documentation of studies
- Provide expert opinion on pharmacokinetic studies planned or performed
- Contribute to the design, monitoring, and reporting of nonclinical and clinical pharmacokinetic and metabolism studies performed by clients or at CROs
Hurley Consulting Associates Ltd. offers a competitive salary, health care benefits, group life insurance, and a 401(k) plan.