Senior Scientific Director, Toxicology

3 weeks ago

San Diego, California, United States Neurocrine Biosciences Full time
About the Role:

As a key member of our Preclinical Development team, the Senior Scientific Director, Toxicology will be responsible for leading the strategic direction of the Toxicology function. This includes ensuring that toxicology studies and programs are conducted in accordance with the appropriate guidelines and regulatory test standards (FDA, WHO, GLP, and ISO). The successful candidate will oversee and evaluate protocol preparation for toxicology studies and reviews reports. They will also advise and direct the analysis, interpretation, and reporting of Safety Pharmacology and Toxicology data for discovery and development programs.

Responsibilities:
  • Develops, implements, and directs toxicology strategies to support assigned discovery and development programs.
  • Supports planning and execution of Safety Pharmacology and Toxicology studies/data for all programs.
  • Oversees and directs assignments within the regulatory Toxicology function to ensure timely completion of priority activities.
  • Evaluates, interprets, and summarizes toxicology results and proactively provides strategic direction to project teams and senior management on the potential impact of toxicology results on Program and Clinical/Regulatory strategy.
  • Advises and directs the preparation of Safety Pharmacology and Toxicology sections of regulatory documents (IND, CTA, NDA, briefing books, Investigator Brochures, etc.).
  • Represents Preclinical Development on discovery and development-stage program teams.
  • Provides strategic oversight and direction for the preparation of data summaries and contributes to the presentation of results to peers, colleagues, and Neurocrine Management.
  • Oversees and drives the preparation of SOPs as needed to guide functional activities and ensures adherence to SOPs.
  • Oversees the adherence of regulatory toxicologists to all Toxicology SOPs.
  • Maintains current knowledge of regulatory guidance, industry standards, and recommendations.
  • Participates in the selecting, developing, and evaluating personnel to ensure the efficient operation within the toxicology group.
Requirements:
  • PhD in Toxicology, Pathology, or a closely related discipline and 10+ years of pharmaceutical/biotech experience, including managing clinical Contract Research Organizations.
  • Exhibits ability to become company-wide advisor and emerging industry expert.
  • Demonstrated strategy development and implementation within areas of responsibility.
  • Possesses expert knowledge of own function and broad knowledge of multiple functions and impact on business.
  • Proven leadership skills and ability, including influencing across many levels of the organization.
  • Expert knowledge of drug development strategies for various modalities, including small molecules, biologics, therapeutic peptides, therapeutic areas (including neuroscience and endocrinology), and regulatory regions (including US, Canada, Europe, and Japan).
  • Expert knowledge of managing clinical Contract Research Organizations (CROs).
  • Demonstrated experience in the preparation of INDs, CTAs, NDAs, and MAAs.
  • Maintains broad knowledge of scientific principles and theories and possesses intellectual mastery of multiple scientific areas.

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