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San Diego, California, United States
Onsite
Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering, developing and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, 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 more than 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, Facebook and YouTube. (*in collaboration with AbbVie)
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By applying innovative quantitative approaches to guide key development decisions, the Sr. Principal Scientist enhances program efficiency, scientific quality, and regulatory readiness
Lead pharmacometrics tasks and serve as function lead for assigned clinical development program. Recommend strategic direction for modeling and simulation activities for various projects
Independently conduct and report population PK, PK/PD, and Exposure-Response analyses to support dose selection, clinical trial design and regulatory submissions
Oversee the design and reporting of M&S analyses conducted by external Contract Research Organizations (CROs)
Contribute to the M&S sections for internal decision-making boards, regulatory documents, interactions and responses
Prepare posters, publications, presentations for internal and external conferences in quantitative pharmacology and pharmacometrics science
Performs other duties as assigned
PhD, PharmD, or equivalent preferred in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with a specific focus on PK and PK/PD modeling and simulation and 5+ years of drug development experience post PhD/PharmD OR
MS and 8+ years of Pharmaceutical/Biotech industry experience
Expert knowledge in conduct and/or oversight of early and late-stage Modeling and Simulation activities
In depth knowledge of all stages of clinical drug development, including the preparation of components of the Clinical Pharmacology sections of Regulatory submissions for IND- and NDA-stage projects
Proficient with the use of PK and PK/PD Modeling software tools including NONMEM, R and WinNonlin
Significant expertise in preparing NDA/MAA summaries of population modeling analyses would be highly beneficial
Strong communications, problem-solving, analytical thinking, influencing skills
Applies understanding of the team's place in the larger organization, and discusses changes, progress, and issues as they relate to other areas
May utilize working knowledge of other related disciplines to provide solutions to a wide range of difficult problems
Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams
Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
Excellent project management, strong project leadership skills
Ability to work in a cross functional team and matrix environment
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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.
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The annual base salary we reasonably expect to pay is $156,900.00-$214,000.00. 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 30% 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.