Executive Director, DMPK

3 days ago

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

We are seeking an experienced Executive Director to lead our Preclinical Pharmacokinetics function within the Preclinical Development organization. As a key member of our team, you will provide strategic leadership and oversight to ensure the successful development of clinical candidates with acceptable drug development characteristics.

Key Responsibilities:

  • Develop and implement departmental strategies to evaluate Preclinical Pharmacokinetics, including training, techniques, and equipment.
  • Lead and manage the conduct, interpretation, and reporting of preclinical pharmacokinetic studies.
  • Collaborate with Research and Preclinical Development colleagues to establish optimal lead candidate characteristics, develop testing schemes, and design, conduct, and report on preclinical studies.
  • Design and conduct Preclinical Pharmacokinetic and Toxicokinetic/Pharmacokinetic/Pharmacodynamic studies in support of clinical development compounds.
  • Oversee the preparation of Preclinical Pharmacokinetic sections of regulatory documents.
  • Lead research-stage and development-stage program teams from a strategic and tactical level.
  • Prepare data summaries and present results to peers, colleagues, and regulatory agencies.

Requirements:

  • Bachelor's in chemistry, life sciences, or closely related discipline and 17+ years of pharmaceutical/biotech experience, with extensive management experience.
  • Experience in managing preclinical Contract Research Organizations.
  • Excellent knowledge of preparation of INDs, CTAs, NDAs, and MAAs.
  • Working knowledge of in silico modeling and simulation tools.
  • Proactive, innovative, with good problem-solving skills.
  • Knowledgeable of and current on regulatory guidance.
  • Acts as a 'trusted advisor' across the company and may be recognized as an external expert.
  • Provides strategy, vision, and direction regarding issues that may have company-wide impact.

About Neurocrine Biosciences

We are a leading neuroscience-focused, biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders.

Our diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis, and uterine fibroids, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas.

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