Job Category: Clinical & Statistics

Senior Manager, Toxicology

Job Location: Hawthorne, N.J.

Toxicologist / Study Monitor is responsible for the design, implementation, report and interpretation of nonclinical safety pharmacology & toxicology studies in support of discovery and development programs.

RESPONSIBILITIES:
Contribute to and help implement an overall drug development strategy to support nonclinical and clinical pharmacology development during all stages of drug development. Design, implement, report and interpret nonclinical study data of small molecule or other novel drug candidate constructs. Prepare study synopses, protocols, study reports and regulatory documents to support nonclinical development of the pipeline drug candidates. Interact/collaborate with CROs, universities or analytical laboratories, as necessary to ensure appropriate/timely progression of multiple projects. Effectively communicate nonclinical and clinical findings and their relevance to project teams, collaborators, and regulatory agencies (i.e. FDA, EMEA, MHRA, ROW). Participate in multi-disciplinary drug development teams. Experience with managing portfolios for expert area including invoicing and forecasting.

REQUIREMENTS:
PhD degree in Biochemistry, Pharmacology, Toxicology or equivalent Non clinical pharmacology/toxicology background and 5+ years of experience in the pharmaceutical, CRO, and/or biotechnology field. BSc / MSc in Biochemistry, Pharmacology, Toxicology or equivalent Non clinical pharmacology/toxicology background and 10+ years of experience in the pharmaceutical, CRO, and/or biotechnology field. Strong understanding of drug development and regulatory process, as well as a strong understanding of Good Laboratory Practices (GLPs). Experience supporting the development of small molecules, including management of CROs to initiate, plan and finalize study reports for GLP and non-GLP nonclinical studies. Experience with the preparation of regulatory submissions (IND/CTDs, NDA/BLA, etc.) and communicating/interacting with health authorities desirable. Proficient at Word, Excel, and PowerPoint.

Please contact Bill Emker at bemker@clarkdavis.com

130-150K

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