Executive Director, DMPK

2 weeks ago

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

We are seeking a highly experienced and skilled Executive Director to lead our Preclinical Pharmacokinetics function within the Preclinical Development organization at Neurocrine Biosciences. As a key member of our team, you will be responsible for providing strategic leadership and oversight to ensure the successful development of clinical candidates with acceptable drug development characteristics.

Key Responsibilities
  • Develop and implement strategic plans, objectives, and policies for the Preclinical Pharmacokinetics function.
  • Provide scientific leadership and oversight to ensure the timely and accurate dissemination of Preclinical Pharmacokinetics data.
  • Work closely with internal and external colleagues to establish optimal lead candidate characteristics, develop appropriate testing schemes, and design, conduct, and report on preclinical studies.
  • Oversee the preparation of Preclinical Pharmacokinetic sections of regulatory documents, including INDs, NDAs, and briefing books.
  • Lead and manage the conduct, interpretation, and reporting of preclinical pharmacokinetic studies.
  • Design and conduct Preclinical Pharmacokinetic and Toxicokinetic/Pharmacokinetic/Pharmacodynamic studies in support of clinical development compounds.
  • Actively participate in research-stage and development-stage program teams from both a strategic and tactical level.
  • Prepare data summaries and present results to peers, colleagues, the Management Committee, and regulatory agencies.
  • Prepare Standard Operating Procedures (SOPs) as needed to guide the Preclinical Pharmacokinetics activities.
Requirements
  • Bachelor's in chemistry, life sciences, or a closely related discipline and 17+ years of pharmaceutical/biotech experience, with extensive management experience.
  • Experience in managing preclinical Contract Research Organizations.
  • Experience managing preclinical scientists and preparation of INDs, CTDs, NDAs, and MAAs.
  • Experience with silico modeling and simulation tools is beneficial.
  • MS in Pharmacokinetics, Pharmaceutical Sciences, or a closely related discipline and 15+ years of similar experience.
  • PhD in Pharmacokinetics, Pharmaceutical Sciences, or a closely related discipline or PharmD and 12+ years of similar experience.
  • Demonstrated leadership of a Preclinical Pharmacokinetic function.
  • Extensive 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.
  • Requires in-depth knowledge of the functional area, business strategies, and the company's goals.
  • Possesses industry-leading knowledge.
  • Ability to work strategically in a cross-functional team and matrix environment.
  • Excellent written, presentation, and verbal communication skills.
  • Exceptional leadership, coaching, employee development skills.
  • Demonstrated ability to negotiate and influence others with or without authority at all levels of the organization.

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