Director of Toxicology - SIGA Technologies, Inc

Position Description

The Director Toxicology will direct the nonclinical in vitro and in vivo aspects of toxicology studies to support product development and participate in pharmacokinetic and toxicological assessments of clinical trials. This person will ensure the transition of safety assessment information from the preclinical stages in to clinical development and analyze, review and report data from clinical pharmacokinetic studies to the project team. The Director will represent project teams on preclinical matters; critically evaluate and interpret results of scientific experiments and contribute to appropriate sections of INDs, NDAs and other regulatory documents and represent, if needed, these areas in meetings with regulatory agencies.

Requirements

A PhD or MS in toxicology, pharmacology or affiliated course of study together with 8-10 years of pharmaceutical industry experience. Extensive experience with the design, implementation, and execution of toxicology, pharmacology, and pharmacokinetics studies. Training and experience with US and international GLP requirements is essential.

Experience and responsibility in preparing IND and NDA.
Experience in working with contract labs and outstanding relationships with lab study directors
Experience in FDA interactions
Excellent oral and written communication skills
Experience in safety pharmacology
Experience in the field of antivirals (desirable)
A basic understanding of PK/PD is preferred and basic understanding of clinical development is desirable.

Responsibilities

Work with outside experts to develop nonclinical strategies for company’s drug discovery pipeline.

Develop plans for conducting safety pharmacology and exploratory toxicology studies and studies to support regulatory submissions: identify contract labs for conducting the studies, generate protocols and closely support/monitor the conduct of these studies.

Provide analysis and interpretation of data and preparation for final reports, critically review and edit study reports.

Assume team representation at project teams. Design and support project related in-house experiments with expertise and experience.

Identify and apply novel technology and expertise to enhance drug discovery research programs.

Respond quickly to information learned from ongoing studies and provide input to drug discovery and development management to guide program direction and prioritization.

Work with company’s CMC team to ensure supply of appropriate nonclinical test materials.

Generate/review regulatory documents for pre-IND packages, IND and NDA submissions, and Investigator’s Brochures.

Provide assistance to the Project Manager in summarizing results for presentation to FDA and others within the company.

May interact with FDA on nonclinical matters.

How to Apply

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