Head of Toxicology

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Company: Neurocrine Biosciences
Location: San Diego, CA 92130

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Who We Are:

At Neurocrine Biosciences – voted one of San Diego’s top places to work in 2018 – we pride ourselves on having a strong, distinctive and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose – to relieve patient suffering and enhance lives.


What We Do:

Neurocrine Biosciences is a biopharmaceutical company focused on developing treatments for neurological and endocrine related disorders.


About the Role:

The Head of Toxicology will be a key leader in the Preclinical Development group at Neurocrine Biosciences that oversees ADME, Toxicology and Clinical Pharmacology activities. This individual will be responsible for overseeing the Toxicology function at Neurocrine and the analysis, interpretation and reporting of Safety Pharmacology and Toxicology data for Neurocrine’s Discovery and Development programs. The position will liaise with Research and Development colleagues to develop overall Safety Pharmacology and Toxicology Development Strategies for subsequent ratification by project teams. The individual will also represent Preclinical Development on Discovery and Development teams and regularly interface with internal and external colleagues to ensure timely and accurate dissemination of Safety Pharmacology and Toxicology findings.

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Your Contributions (include, but are not limited to):

  • The primary role is to lead the Toxicology group in the conduct, interpretation and reporting of Safety Pharmacology and Toxicology studies/data
  • Manage project assignments within the Toxicology function to ensure timely completion of priority activities
  • Critically evaluate toxicology results and provide strategic advice to project teams and senior management on the potential impact of toxicology results on Program and Clinical/Regulatory strategy
  • Oversee the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (IND, NDA, briefing books, Investigator Brochures, etc.)
  • Represent Preclinical Development on discovery and development-stage program teams
  • Oversee the preparation of data summaries and presentations of results to peers, colleagues and Neurocrine Management.
  • Prepare SOPs as needed to guide functional activities
  • Be knowledgeable with current regulatory guidances
  • Inspire, mentor and grow Neurocrine’s Toxicology team
  • Other tasks as assigned

Requirements:


  • Ph.D. in Toxicology, Pathology or closely related discipline or D.V.M. with at least 15 years of pharmaceutical/biotech experience
  • Knowledge/experience in toxicologic pathology is beneficial
  • Experience in managing clinical Contract Research Organizations
  • Experience with preparation of INDs, CTDs, NDAs, and MAAs
  • Proactive, innovative, with good problem-solving skills
  • Experience working in a cross functional team and matrix environment
  • Excellent written, presentation, and verbal communication skills

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.