Sr. Principal/Assoc. Scientific Director, Pharmacometrics

Role Summary

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.

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

Qualifications

• 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