Director/Associate Director, Pharmacometrics

NS Pharma Inc•Paramus, NJ

1d•$190,000 - $215,000•Hybrid

About The Position

NS Pharma is a highly focused, research-driven biopharmaceutical company working in rare diseases. We're exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan. Job Summary Provides scientific and strategic leadership in pharmacometrics to support development programs, including rare disease and oncology. Responsible for developing and executing model-informed drug development (MIDD) strategies that enable key development decisions, optimize dosing strategies, support regulatory interactions, and contribute to successful global development and regulatory approvals. Serves as a technical leader within the organization, providing quantitative expertise, hands-on scientific leadership, and technical mentorship across global teams, including the Japan organization. Contributes to the development of organizational pharmacometrics capabilities through implementation of best practices, advancement of quantitative methodologies, and establishment of appropriate systems, tools, and infrastructure.

Requirements

Deep understanding of clinical development, clinical pharmacology, pharmacometrics, and MIDD.
Hands-on experience with pharmacometric software and quantitative analysis tools, including NONMEM, R, Simcyp, and other relevant platforms.
Demonstrated hands-on experience independently conducting pharmacometric analyses from analysis planning through execution, interpretation, reporting, and regulatory application, including authoring analysis plans, reports, regulatory submission documents, and responses to health authority questions.
Demonstrated experience establishing, maintaining, and continuously improving pharmacometrics infrastructure, systems, tools, workflows, and quality processes that support efficient and scientifically rigorous MIDD.
Demonstrated technical leadership, scientific judgment, and ability to effectively communicate and influence stakeholders in a matrix development environment.
PhD, PharmD, MS, or equivalent advanced degree in clinical pharmacology, pharmacometrics, pharmacokinetics, pharmaceutical sciences, statistics, applied mathematics, engineering, or a related quantitative scientific discipline.
Typically 10+ years (Associate Director) or 12+ years (Director) of relevant industry experience in pharmacometrics within the pharmaceutical or biotechnology industry.
Demonstrated experience applying pharmacometrics to support development programs from early clinical development through regulatory approval, including population PK, PK/PD, exposure-response analyses, regulatory submissions, and health authority interactions.
Experience managing external consultants, vendors, and CRO partnerships.
Demonstrated ability to mentor and develop scientists in pharmacometrics and quantitative drug development.

Responsibilities

Develop and execute pharmacometrics strategies across development programs to inform key development decisions, including dose selection and optimization, and study design.
Advance organizational pharmacometrics capabilities through implementation of best practices and innovative approaches.
Lead and/or directly contribute to pharmacometric analyses, including population pharmacokinetics, exposure-response analyses, physiologically based pharmacokinetic (PBPK) modeling, and other quantitative approaches, and apply quantitative insights to address key clinical development questions.
Provide scientific oversight and technical guidance for the design, interpretation, communication, and application of pharmacometric analyses.
Represent pharmacometrics on cross-functional development teams, partnering closely with Clinical Pharmacology, Clinical Research, Biostatistics, DMPK, Discovery, and Regulatory Affairs to support clinical development and regulatory strategies.
Support regulatory submissions and health authority interactions through authoring or reviewing pharmacometric sections of regulatory documents, briefing materials, submission packages, and responses to health authority questions, ensuring alignment with current regulatory expectations and industry best practices.
Provide technical leadership, mentoring, and scientific coaching to pharmacometrics scientists across global locations, including members of the Japan organization.
Establish and strengthen organizational pharmacometrics capabilities, systems, tools, workflows, and best practices to support efficient and scientifically rigorous MIDD.
Manage and oversee pharmacometric activities conducted by external consultants, vendors, and CRO partners, ensuring timely delivery of high-quality analyses and regulatory documentation.
Monitor emerging scientific and regulatory developments relevant to pharmacometrics and MIDD and facilitate adoption of appropriate methodologies and practices.
Provides technical leadership and mentorship across pharmacometrics activities and development programs.
Supports capability development across global teams, including the Japan organization, and may oversee activities conducted by external consultants, vendors, and CRO partners.