Sr. Principal/Assoc. Scientific Director, Pharmacometrics

Role Summary

The Sr. Principal/Assoc. Scientific Director, Pharmacometrics leads pharmacokinetic (PK) and pharmacodynamic (PD) modeling and simulation (M&S) efforts that drive the clinical development of Neurocrine’s small- and large-molecule programs. The role provides strategic PK/PD methodology expertise, performs or oversees pharmacometric analyses, and communicates findings to cross-functional stakeholders. It contributes to the design and execution of the Clinical Pharmacology and Pharmacometrics Development Plan and mentors colleagues to advance excellence within the function.

Responsibilities

• Lead pharmacometrics tasks and serve as function lead for assigned clinical development programs; recommend strategic direction for modeling and simulation activities.
• Independently conduct and report population PK, PK/PD, and Exposure-Response analyses to support dose selection, trial design, and regulatory submissions.
• Oversee design and reporting of M&S analyses conducted by external CROs.
• Contribute to M&S sections for internal decision-making boards, regulatory documents, interactions, and responses.
• Prepare posters, publications, and presentations for internal and external conferences in quantitative pharmacology and pharmacometrics.
• Mentor and may direct projects of critical importance; perform other duties as assigned.

Qualifications

• PhD, PharmD, or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with 5+ years of drug development experience post PhD/PharmD, OR MS with 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 preparing components of Clinical Pharmacology sections of regulatory submissions for IND- and NDA-stage projects.
• Proficient with 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, and influencing skills.
• Ability to work within a matrix, cross-functional team; discuss changes, progress, and issues as they relate to other areas.
• Leadership and mentoring abilities; typically leads lower levels and/or indirect teams.
• Ability to meet multiple deadlines across various projects with high accuracy and efficiency; excellent project management and leadership skills.

Education

• PhD, PharmD, or equivalent in a related field; or MS with substantial industry experience in pharmacometrics.