Sr. Principal/Assoc. Scientific Director, Pharmacometrics jobs in United States
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Neurocrine Biosciences · 1 week ago

Sr. Principal/Assoc. Scientific Director, Pharmacometrics

Neurocrine Biosciences is a leading neuroscience-focused biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients. The Associate Director, Pharmacometrics leads pharmacokinetic and pharmacodynamic modeling efforts to drive clinical development and enhances program efficiency through innovative quantitative approaches.

BiotechnologyHealth CarePharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

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

Qualification

PharmacokineticsModelingSimulationDrug DevelopmentPK/PD ModelingRegulatory SubmissionsNONMEMRWinNonlinAnalytical ThinkingLeadershipCommunicationProblem-solvingProject Management

Required

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

Benefits

Annual bonus with a target of 30% of the earned base salary
Eligibility to participate in our equity based long term incentive program
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

Company

Neurocrine Biosciences

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Neurocrine Biosciences engages in the discovery and development of drugs for the treatment of neurological and endocrine-related diseases.

H1B Sponsorship

Neurocrine Biosciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (9)
2023 (8)
2022 (2)
2021 (5)
2020 (6)

Funding

Current Stage
Public Company
Total Funding
$260M
Key Investors
Venrock
2015-02-19Post Ipo Equity· $250M
2009-12-17Post Ipo Equity· $10M
1996-05-31IPO

Leadership Team

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Matt Abernethy
Chief Financial Officer
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Dimitri Grigoriadis
VP, Research
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Company data provided by crunchbase