Principal Investigator, Toxicology

SUMMARY

The Principal Investigator will have a key role in the discovery and development of Neurocrine’s development compounds. Working with Neurocrine colleagues, the Principal Investigator will participate in all stages Toxicology/Safety Pharmacology assessment, from study planning through to regulatory submission. In this role, the individual will provide strategic and operations direction ensuring all studies are conducted in line with appropriate guidelines and regulatory testing standards and individual program objectives. The individual will also represent Toxicology on Development teams and regularly interface with colleagues to ensure timely and accurate dissemination of Toxicology/Safety pharmacology findings.

 Primary Duties and Responsibilities

  • Develop and implement plans for preclinical testing of new and current drug candidates
  • Select and manage Toxicology and Safety Pharmacology CROs
  • Oversee and lead protocol preparation for Toxicology and Safety Pharmacology studies and manage the conduct and reporting of individual studies, including study placement, contract development/budgeting, coordination of pre-study activities, and approving study protocols and reports
  • Perform thorough analyses/interpretations of Toxicology/Safety Pharmacology data and participate in go/no-go decision making
  • Prepare SOPs as needed to guide the Toxicology and Safety Pharmacology programs
  • Author and/or review Toxicology and Safety Pharmacology sections of all regulatory documents, including IND, CTA, IB, annual report, and NDA/MAA submissions
  • Keep up-to-date with current regulatory guidance

QUALIFICATIONS:

  • PhD in Toxicology, or equivalent; DABT certification is desirable
  • Strong expertise in Safety Pharmacology is desirable
  • Minimum 3 years of experience in CRO and/or pharmaceutical industry in the conduct and/or oversight of small molecule Toxicology/Safety Pharmacology programs

EXPERIENCE:

  • Current knowledge of ICH and FDA guidance
  • Experience in managing preclinical Contract Research Organizations
  • Experience with preparation of INDs, CTDs, NDAs, and MAAs preferred.
  • Proactive, innovative, with good problem solving skills
  • Experience working in a cross functional team and matrix environment
  • Strong written, presentation, and verbal communication skills

Apply Online