Sr. Principal Scientist, Pharmacometrics

Neurocrine Biosciences•San Diego, CA

About The Position

Lead internal and external clinical pharmacokinetic (PK) and pharmacodynamics (PD) modeling and simulation activities. Oversees the design, conduct, and reporting of modeling and simulation analyses conducted by external Contract Research Organizations (CROs) in support of product registration of a small molecule therapeutic. Conducts internal PK/PD modelling and simulation in support of early stage programs or internal decision-making of late-stage programs. Will present modelling and simulation analyses to internal project teams and may present to external colleagues or regulatory agencies. Will contribute to the preparation of an overall Clinical Pharmacology/Pharmacometrics Development Plan for NBI development compounds.

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 7+ years of drug development experience post PhD/PharmD OR MS and 13+ years of Pharmaceutical/Biotech industry experience
Applies understanding of the team's place in the larger organization, and discusses changes, progress, and issues as they relate to other areas
Maintains substantial knowledge of principles and theories and acts as a technical lead on various projects
Leads the development of intellectual property
May utilize working knowledge of other related disciplines to provide solutions to a wide range of difficult problems
Ability to work as part of and lead multiple teams
Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams
Excellent communications, problem-solving, analytical thinking skills
Sees broader picture and longer-term impact on division/company
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
Expert knowledge in conduct and/or oversight of late-stage Modeling and Simulation activities, including conduct or oversight of small molecule population pharmacokinetic analyses
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
Demonstrated ability to independently design novel/highly complex studies to characterize PK/PD relationships of clinical development compounds
Competent in the use of PK and PK/PD Modeling software tools including WinNonlin, NONMEM, S-Plus and SAS

Nice To Haves

Significant expertise in preparing NDA/MAA summaries of population pharmacokinetic PK/PD analyses would be highly beneficial

Responsibilities

Leads internal and external clinical PK and/or PK/PD modeling and simulation activities
Develops novel and creative solutions to overcome issues/study obstacles
Oversees the design, conduct, and reporting of modeling and simulation analyses conducted by external Contract Research Organizations (CROs) in support of regulatory submissions
Provides expert consultation for PK/PD data from Phase 1/2 studies and application of quantitative decision-making to assist in the elucidation of dose- and exposure-response relationships to optimize subsequent clinical development
Significantly contribute to the PK analysis, interpretation and reporting of PK results from clinical trials
Expert resource for Nonclinical colleagues to lead/drive PK/PD modeling of discovery and development compounds in nonclinical test systems
Development and implementation of industry leading, long-term Modeling and Simulation strategy for the organization
Reports on results through written contributions to Clinical Study Reports
Contributes to standards and best scientific practices development, maintenance and communication
May lead publication of ﬁndings or is a major contributor to these processes
Performs other duties as assigned

Benefits

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

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