Director, Pharmacology

Hurley Consulting Associates Ltd. is seeking a Pharmacologist to join our Scientific Affairs group.  PhD with a minimum of 5 to 10 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).  Specific skill sets for this position include the following:

• Experience and knowledge of cell and tissue culture, differentiation and expansion, characterization, and banking
• Experience and knowledge of bioanalytical assay development and validation
• Experience and knowledge of animal models of disease (i.e. immunology/inflammation, oncology, metabolic diseases, neurobiology, infectious diseases, etc.)

The responsibilities include:

• Contribute to the preparation of regulatory submissions including INDs, NDAs, and BLAs which includes preparation of written and tabular pharmacology summaries   
• Participate in cross-functional teams as a pharmacology expert and provide support to others in the preparation, analysis, and documentation of studies
• Provide expert opinion on pharmacology studies planned or performed
• Contribute to the design, monitoring, and reporting of nonclinical pharmacology studies performed by clients or at CROs
• Interact with clients and regulatory authorities when needed to address pharmacology related matters

Hurley Consulting Associates Ltd. offers a competitive salary, health care benefits, group life insurance, and a 401(k) plan.