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Distinguished Scientist, Toxicology

Framingham, MA
Job Order: GD-732

Job Descriptions:

  • Serve as Preclinical Safety project team representative on multi-disciplinary Discovery and Development teams responsible for the progression of both biotherapeutics and small molecule compounds for regulatory submissions.  These activities include designing and coordinating a multi-disciplinary effort to support such projects through the development of the nonclinical safety strategy and program which includes, but is not limited to attending various project team meetings; the design and interpretation of toxicity studies; the preparation and/or review of written safety pharmacology and toxicology reports; and the authoring of the nonclinical document sections for regulatory submissions (including CIBs INDs, MAAs, CTAs, CTDs and BLAs)
  • Interact with multiple functions (Pharmacology, Regulatory Affairs, Clinical, Project Leaders & Managers, etc.) on a daily basis
  • Participate in issue-resolution teams, where she/he will be required to contribute to hypotheses generation and drive the science for toxicology issue resolution in drug discovery and development.
  • Participate in Preclinical safety-US and global Preclinical safety Department activities (staff meeting, scientific forums, etc.), and special projects
  • Participate in special projects or inter-industry working groups, as needed.  Provide scientific input on design and analysis of research activities
  • Serve as internal expert for scientific issues related to nonclinical safety issues
  • Ensure high scientific standards and adhering to requested timelines in all aspects of the position

 

Job Requirements:

  • PhD in toxicology, pharmacology, immunology or related disciplines and two years of post-doctoral experience
  • A minimum of 12 years of relevant industry experience
  • Knowledgeable about GLP policies and/or regulatory nonclinical testing requirements for pharmaceutical development of biotherapeutics and small molecules
  • Preparation of regulatory documents for submission to health authorities
  • Excellent verbal and written communication skills
  • Demonstrate leadership and expertise in preclinical safety disciplines
  • PhD in toxicology, pharmacology, immunology or related disciplines and two years of post-doctoral experience
  • The candidate should have knowledge in biochemistry, toxicology, pharmacology, Immunology, physiology, and statistics.
  • DABT certification is preferred, but not required.
  • Experience as a GLP Study Director is preferred.

 

DATE POSTED 2019-12-09

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