Mission Statement:

The qualified candidate will design and oversee the nonclinical safety testing programs for assigned clinical candidates in development. Specific responsibilities will include: nonclinical study design, contract research laboratory (CRO) selection, study director interactions / monitoring, study result interpretation, report finalization, and preparation of integrated nonclinical summaries for IND and NDA submissions.  

Responsibilities:

• Design safety testing program (including safety pharmacology, pharmacokinetics, and toxicology testing) for assigned clinical candidates
• Responsible for the preclinical program in assigned therapeutic area. 
• Review and finalize study reports as per GLP's
• Serve on selected project teams and/or subteams.
• Assess mechanism(s) of toxicity to determine clinical relevance and ways to minimize clinical impact.
• Prepare all relevant nonclinical regulatory documents (study summaries, CTD tables, and integrated summaries) and respond to issues.  

Qualifications: 

• Ph.D. with 3-5 years of experience as a toxicologist within the pharmaceutical / biopharmaceutical industry.
• Board certification a plus
• Familiarity with the worldwide nonclinical testing guidelines to support clinical development and registrational filings.