Responsible for conducting a wide variety of in vivo and in vitro
regulatory toxicology and safety pharmacology studies for anti-viral
compounds in various stages of preclinical research and development.
Serving as Study Monitor, this individual will identify CROs for studies
(single and repeat dose toxicity, DART, genotoxicity, carcinogenicity
studies, etc.); oversee protocol design and negotiate budgets; ensure
their timely conduct and delivery of reports; interpret and edit study
reports; and prepare summary reports for regulatory submissions. Will
assist in the preparation of the pharmacology/toxicology sections for
annual reports, IBs, INDs and NDAs, and will participate in generating
written responses to inquiries received from regulatory agencies.
PhD in Toxicology, Pharmacology or DVM, VMD. A minimum of 5-years
post-doctoral industrial experience (pharmaceutical, biotechnology,
contract research organizations) with a proven record of designing,
implementing, managing and analyzing in vivo and in vitro preclinical
toxicology and safety pharmacology studies to support small molecule
developmental candidates. Significant experience serving as Study
Monitor for studies placed at various contract research organizations
Working knowledge of good laboratory practice (GLP) regulations and
federal and global regulatory (FDA, ICH, OECD, etc.) guidances and
guidelines. Experience in filing INDs and other regulatory submissions,
and interfacing with regulatory authorities.
Post-doctoral training/experience in ADME/PK, immunology or infectious
Idenix offers an excellent benefits package including competitive
salary, equity compensation, major medical insurance, dental insurance,
401(k) plan participation, and group life and disability insurance.
To be considered for this position, please send your resume by email to
h...@idenix.com, or by mail to:
60 Hampshire Street
Cambridge, MA 02139
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, MA, is a
biopharmaceutical company engaged in the discovery, development and
commercialization of drugs for the treatment of human viral and other
infectious diseases. Idenix's current focus is on the treatment of
infections caused by hepatitis B virus, hepatitis C virus and human
immunodeficiency virus. For more information about Idenix
Pharmaceuticals, please visit our website at www.idenix.com
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