Job Description:

Who We Are:

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 patient suffering and enhance lives.

What We Do:

Neurocrine Biosciencesis a neuroscience-focused, biopharmaceutical company with 28 years of experience discovering and developing life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, with three pivotal and five mid-stage clinical programs in multiple therapeutic areas. Headquartered inSan Diego,Neurocrine Biosciencesspecializes in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. (*in collaboration with AbbVie)

About the Role:

Responsible for performing modeling and simulation analyses of pharmacokinetic (PK) and/or pharmacodynamic (PD) data in support of compound development. Focused on hands-on ability of population modeling, this individual will provide PK, PD or exposure-response (E-R) analysis results and interpretation to inform decision-making inside and outside the department. May be required to collaborate with cross-functional multidisciplinary teams and develop models to quantify and predict E-R relationships to inform optimal decision making on key development questions such as dose selection and trial design. May be required to publish manuscripts and posters, present at scientific conferences and other scientific forums.

_

Your Contributions (include, but not limited to):

• Collaborates with Clinical Pharmacology to plan and execute pharmacometrics and other quantitative analyses during the first-in-human study




• Develops pharmacometrics models (population PK and E-R if feasible) and performs model simulations as appropriate for early clinical programs following the learn-and-confirm paradigm




• Communicates results and interpretation of pharmacometrics modeling analyses and scientific opinions to line management and study team members




• Works with Biometrics to retrieve SDTM and ADaM data for clinical studies included in the pharmacometrics analysis plan




• Assembles analysis datasets for pharmacometrics modeling according to software specifications




• Proactively incorporate and develop approaches and methodologies based on review of relevant scientific literature




• Support authoring sections for regulatory interactions and responses




• Participate in maintaining scientific awareness and presence in pharmacometric science, preparation of abstracts and manuscripts for publication




• Other duties as assigned

Requirements

• BA/BS Degree with a focus in biometrics, biomedical engineering or other related field and 5+ years of experience in pharmaceutical industry. Experience representing application of pharmacometrics in drug development teams and hands-on modeling experience OR




• Master's Degree with a focus in pharmacometrics or other related field and 3+ years of similar experience noted above OR




• PhD with a focus in pharmacometrics or other related fieldsome experience similar experience noted above




• Demonstrated expertise and/or documented training in analyzing PK and PD data using the population modeling approach




• Proficiency in commonly used software including NONMEM, Monolix, R, SAS




• Ability to assemble NONMEM ready analysis datasets from source SAS datasets efficiently




• Persistence in problem-solving when performing modeling analysis




• Good interpersonal and project management skills




• Effective written and verbal communication skills




• Familiarity with drug development processes




• Demonstrates solid level of understanding project / group goals and methods




• Consistently recognizes anomalous and inconsistent results and interprets experimental outcomes




• Able to explain the process behind the data and implications of the results




• Strong knowledge of one or more scientific disciplines, becoming expert in one discipline




• Strong knowledge of scientific principles, methods and techniques




• Strong knowledge and demonstrated ability working with a variety of laboratory equipment/tools




• Ability to work as part of a team; may train lower levels




• Excellent computer skills




• Strong communications, problem-solving, analytical thinking skills




• Detail oriented yet can see broader picture of scientific impact on team




• Ability to meet multiple deadlines, with a high degree of accuracy and efficiency




• Strong project management skills

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

Apply Now