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Toxicologist

Reference Number: 2965
Location: Midwest

Our client is a well-financed, clinical-stage biotechnology company.  They have asked us to assist them in their search for a Toxicologist.

Reporting to the Executive Director, Toxicology, the incumbent will participate on multidisciplinary project teams where s/he will assist in optimizing development plans; design, conduct, and interpret nonclinical toxicology and investigational safety studies; and effectively communicate with worldwide regulatory agencies to bring our client’s drugs to patients as quickly as possible.  This is an ideal position for an independent individual with a strong background in preclinical toxicology who enjoys working in a team-oriented and highly cross-disciplinary environment.  This position also offers opportunities to help build a highly efficient nonclinical development group with a clinical-stage company with a promising pipeline.

Major tasks and responsibilities will include:

  • Establishes and maintains close working relationships with internal functional groups such as Pharmaceutical Development and CMC, Regulatory Affairs, Clinical Development, and Program Management.
  • Provides toxicology support for planned US and international regulatory submissions, including authoring the nonclinical components of regulatory dossiers and communications as well as responses to inquiries from regulatory agencies.
  • Active participation in strategy discussions for the nonclinical toxicology and investigational studies in support of clinical development programs.
  • Actively manages, and serves as Study Monitor as needed for the full spectrum of nonclinical studies supporting marketing authorization.
  • Designs and oversees non-GLP internal investigative studies in rodent and NHP company-managed or affiliated animal facilities.
  • Identifies, qualifies, and monitors nonclinical CROs and vendors supporting various toxicology applications/activities.

We seek candidates with the following qualifications:

  • DVM or PhD in pharmacology, toxicology, or related scientific discipline.  Board certification (DABT) is a plus.
  • 4+ years of directly relevant industry/CRO experience.
  • Proficient knowledge of general toxicology and related disciplines with expertise in one or more areas of specialization (e.g., cardiovascular, immunotoxicology, etc.).
  • Familiarity with current regulatory toxicology guidelines, requirements, and standards (GLP, OECD, ICH, SEND, CTD, etc.) and the ability to develop nonclinical strategies that support expedited US and international clinical development efforts.
  • Experience in authoring nonclinical components of US and international regulatory dossiers.
  • Independent self-starter with the ability to work in a matrixed, cross-functional, team-based drug discovery/development environment.
  • Highly motivated team player willing to contribute to a growing biotech organization.
  • Strong scientific reasoning ability in the proactive identification of potential issues, and the ability to draw conclusions and make appropriate decisions.
  • Exceptional verbal and written communication skills; ability to communicate clearly and effectively with scientific colleagues and senior management.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2965. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.