Toxicologist - (US-MA-Confidential )

Minimum Education: Doctorate
Job Type: Full Time
Jobcode: R-08
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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 focused in therapeutic antibody development
• 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 biopharmaceutical industry.
• Experience in the development of therapeutic monoclonal antibodies would be a plus.
• Familiarity with the worldwide nonclinical testing guidelines to support clinical development and registrational filings.