Executive Director, DMPK

About the RoleDevelops strategic plans, objectives and policies for overall function. Leads the Preclinical Pharmacokinetics function within the Preclinical Development organization. Provides scientific leadership and oversight to ensure that clinical candidates with acceptable drug development characteristics are identified and appropriately characterized and developed. Plays a key role in the discovery and advancement of Neurocrine's development compounds. Works with Neurocrine colleagues to participate in all stages of Preclinical Pharmacokinetic assessments, from compound screening through to IND and NDA regulatory submissions. Represents Preclinical Development on Research and Development teams and regularly interfaces with internal and external colleagues to ensure timely and accurate dissemination of Preclinical Pharmacokinetics.Your Contributions (include, but are not limited to):Provides strategic, functional leadership and oversight to the Preclinical Pharmacokinetic function within Preclinical DevelopmentResponsible for the development and enablement of departmental strategies to evaluate Preclinical Pharmacokinetics including ensuring continued expansion and/or updating of training, techniques and/or equipmentLeads and manages the conduct, interpretation and reporting of preclinical pharmacokinetic studiesWorks 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 candidatesDesigns & conducts Preclinical Pharmacokinetic and Toxicokinetic/Pharmacokinetic/Pharmacodynamic studies in support of clinical development compoundsOversees 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 levelPrepares data summaries and presents results to peers, colleagues, the Management Committee and regulatory agenciesPrepares Standard Operating Procedures (SOPs) as needed to guide the Preclinical Pharmacokinetics activitiesPerforms other duties as assignedRequirements: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. Experience managing preclinical scientists and preparation of INDs, CTDs, NDAs, and MAAs. Experience with silico modeling and simulation tools is beneficial ORMS in Pharmacokinetics, Pharmaceutical Sciences, or closely related discipline and 15+ years of similar experience noted above ORPhD in Pharmacokinetics, Pharmaceutical Sciences, or closely related discipline or PharmD and 12+ years of similar experience noted aboveDemonstrated leadership of a Preclinical Pharmacokinetic functionExtensive experience in managing preclinical Contract Research OrganizationsExcellent knowledge of preparation of INDs, CTAs, NDAs, and MAAsWorking knowledge of in silico modeling and simulation toolsProactive, innovative, with good problem-solving skillsKnowledgeable of and current on regulatory guidanceActs as a "trusted advisor" across the company and may be recognized as an external expertProvides strategy, vision and direction regarding issues that may have company-wide impactRequires in-depth knowledge of the functional area, business strategies, and the company's goalsPossesses industry-leading knowledgeAbility to work strategically in a cross functional team and matrix environmentExcellent written, presentation, and verbal communication skillsExceptional leadership, coaching, employee development skillsDemonstrated ability to negotiate and influence others with or without authority at all levels of the organizationNeurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.The annual base salary we reasonably expect to pay is $277,200.00-$378,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.