Head of Preclinical Pharmacokinetics

Neurocrine Biosciences Inc.

San Diego (CA)

On-site

USD 277,000 - 378,000

Full time

14 days+

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Benefits offered by this job

401(k) with company match

Paid vacation

Health benefits

Job summary

Neurocrine Biosciences in San Diego seeks a senior-level Preclinical Pharmacokinetics leader to shape strategy and oversee PK across development, from discovery through IND/NDA submissions. You will drive study design, data interpretation, and regulatory documentation while coordinating with Research and Development teams.

You will guide a high-caliber team, ensure methodological excellence, and contribute to cutting-edge neuroscience therapeutics.

Qualifications

Bachelor's in chemistry, life sciences or closely related discipline and 17+ years of pharmaceutical/biotech experience, with extensive management experience.
MS in Pharmacokinetics, Pharmaceutical Sciences, or closely related discipline and 15+ years of similar experience noted above OR
PhD in Pharmacokinetics, Pharmaceutical Sciences, or closely related discipline or PharmD and 12+ years of similar experience noted above
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

Responsibilities

Provides strategic, functional leadership and oversight to the Preclinical Pharmacokinetic function within Preclinical Development
Responsible for the development and enablement of departmental strategies to evaluate Preclinical Pharmacokinetics including ensuring continued expansion and/or updating of training, techniques and/or equipment
Leads and manages the conduct, interpretation and reporting of preclinical pharmacokinetic studies
Works with Research and Preclinical Development colleagues to establish optimal lead candidate characteristics, develop appropriate testing schemes, and design, conduct and report on preclinical studies intended to characterize potential drug candidates
Designs & conducts Preclinical Pharmacokinetic and Toxicokinetic/Pharmacokinetic/Pharmacodynamic studies in support of clinical development compounds
Oversees the preparation of Preclinical Pharmacokinetic sections of regulatory documents (IND, NDA, briefing books, Investigator Brochures, etc.).
Actively leads/participates in research-stage and development-stage program teams from both a strategic and tactical level
Prepares data summaries and presents results to peers, colleagues, the Management Committee and regulatory agencies
Prepares Standard Operating Procedures (SOPs) as needed to guide the Preclinical Pharmacokinetics activities
Performs other duties as assigned