Assoc. Scientific Director, Pharmacometrics
About The Position
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values, which is to relieve suffering for people with great needs. Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company 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, relentlessly pursuing medicines to ease the burden of debilitating diseases and disorders. The Associate Director, Pharmacometrics leads the pharmacokinetic (PK) and pharmacodynamic (PD) modeling and simulation (M&S) efforts that drive the clinical development of Neurocrine’s small- and large-molecule programs. This role provides strategic expertise in PK/PD methodology, performs or oversees pharmacometric analyses, and clearly communicates findings to cross-functional stakeholders. It also contributes to the design and execution of the Clinical Pharmacology and Pharmacometrics Development Plan. By applying innovative quantitative approaches to guide key development decisions, the Associate Director enhances program efficiency, scientific quality, and regulatory readiness. The role further demonstrates leadership by mentoring colleagues and directing critical projects, advancing excellence within the Pharmacometrics function.
Requirements
- 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
- 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
- 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
Nice To Haves
- Significant expertise in preparing NDA/MAA summaries of population modeling analyses would be highly beneficial
Responsibilities
- 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
- Serves as a mentor and may direct projects of critical importance
- Performs other duties as assigned
Benefits
- a retirement savings plan (with company match)
- paid vacation, holiday and personal days
- paid caregiver/parental and medical leave
- health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans
- an annual bonus with a target of 30% of the earned base salary
- eligibility to participate in our equity based long term incentive program
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
501-1,000 employees
