Sr. Principal/Assoc. Scientific Director, Pharmacometrics

Neurocrine Biosciences•San Diego, CA

About The Position

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
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

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

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

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