At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, 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. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie)
Develops overall Clinical Pharmacology scientific strategies for assigned Therapeutic Areas (TA) and contributes to the broader functional strategy. Oversees all aspects of pharmacokinetic and pharmacodynamic activities for Neurocrine’s clinical development compounds. Key member of clinical protocol development at all stages and ensures appropriate assessment of Clinical Pharmacology endpoints. Represents Preclinical Development as expert to multidisciplinary project teams for assigned TA/Program, advises Sr. Technical Leadership and Executive Management and regularly interfaces with internal and external colleagues to ensure timely and accurate dissemination of Clinical Pharmacology findings.
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Develops Clinical Pharmacology and quantitative program strategies for assigned TAs that enable development and regulatory decisions
Provides small and/or large molecule clinical pharmacology expertise to cross-functional project teams and support for the preparation of regulatory submissions
Develops new innovative and impactful clinical pharmacology approaches to processes and drug development strategies
Leverages quantitative modelling and simulation tools to answer development questions and to design and inform clinical trial designs and clinical development strategy
Represents clients at meetings and advisory hearings with global health authorities as a subject matter expert
Collaborates in teams both internally and externally as a strategic advisor on regulatory, clinical development, clinical pharmacology, and other development issues
Contributes to training and mentoring for staff, develops junior staff for broader functional roles
Writes and compiles reports and other documents summarizing recommendations
Involvement in program committees, workshops, and other professional organization meetings/sessions
Other duties as assigned
PhD in pharmacology or pharmacokinetics, or in a related scientific discipline or PharmD AND PhD in pharmacology or pharmacokinetics, or in a related scientific discipline or PharmD and 10+ years of drug development experience including clinical pharmacology and regulatory science expertise in the pharmaceutical industry OR OR
Master's in Pharmacokinetics, Pharmaceutical Sciences or closely related discipline AND Master's in Pharmacokinetics, Pharmaceutical Sciences or closely related discipline and 13+ years of relevant experience OR OR
Bachelor's in chemistry, life sciences or closely related discipline AND 15+ years of relevant experience
Recognized Internal thought leader and deep expertise in a discipline
Requires broad, deep and comprehensive expertise in leading-edge theories and techniques for functional area
Applies ingenuity and creativity to problem analysis and resolution in complicated and/or novel situations
Influences internal/external business and/or industry issues that have an impact on Neurocrine
Strong mentoring skills and leadership abilities supervise lower levels and/or leads indirect teams
Proven ability to translate strategy into tactical plans and drive outcomes
Capable of assembling a multidisciplinary team to execute the components of clinical pharmacology program
Exemplary scientist, innovator, drug hunter/developer, expertise in several areas, expert in current area. Exhibits learning agility
Extensive knowledge of managing clinical Contract Research Organizations
Proven track record in preparation of INDs, CTAs, NDAs, and MAAs as well as successful results from the filings
Expert knowledge of in silico modeling and simulation tools
Demonstrated knowledge on current regulatory guidance’s
Ability to develop scientific insights from highly complex data sets; extensive knowledge of pharmacokinetic and pharmacodynamic data interpretation for clinical development compounds
Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization
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Neurocrine 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.
