Director/Associate Director, Pharmacometrics

NS Pharma, Inc.; Paramus (NJ); On-site; USD 190,000 - 215,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

Life Insurance & AD&D

Disability Insurance

401k with company match

Paid Time Off & Holidays

Career Development & Training

Flexible Work Arrangements

Parental Leave

Job summary

NS Pharma, Inc. is seeking a senior leader to oversee pharmacometrics strategy across development programs, including rare disease and oncology, in support of model-informed drug development.

The role provides technical leadership, mentors scientists globally (including Japan), and partners with Clinical Pharmacology, Biostatistics, DMPK and Regulatory Affairs to guide dose selection, design, and regulatory submissions.

Qualifications

• Deep understanding of clinical pharmacology, pharmacometrics, and MIDD.
• Hands-on experience with pharmacometric software (NONMEM, R, Simcyp) and quantitative analyses.
• Proven ability to conduct pharmacometric analyses from planning to regulatory submission.
• Experience building and improving pharmacometrics infrastructure and processes.
• Strong technical leadership and stakeholder influence in a matrix environment.

Responsibilities

• Develop and execute pharmacometrics strategies to inform dose selection and study design.
• Lead pharmacometric analyses and provide guidance to cross-functional teams.
• Support regulatory submissions and health authority interactions.
• Mentor scientists and oversee external vendors/CROs.

Skills

Pharmacometric leadership

MIDD strategy

NONMEM

R

Education

PhD, PharmD, MS, or equivalent degree

Tools

NONMEM

R

Simcyp

Job description

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.

Essential Duties And Responsibilities

Pharmacometrics Strategy and Scientific Leadership

• 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.

Clinical Development and Regulatory Support

• 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.

Technical Leadership, Capability Development and Operational Excellence

• 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.

Supervisory Responsibility

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.

Qualifications

• 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.

Education And Experience

• 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.

Compensation And Benefits

NS Pharma employees embrace our Mission to Help People Lead Healthier Happier Lives. We pride ourselves in offering employees and their families a robust Compensation and Benefits package designed to meet their needs, on and off the job.

The annualized target salary range for this role is Associate Director $190,000 to $200,000 and Director $205,000 to $215,000 actual salaries will vary and may be above or below this range depending on several factors, including experience, education, training, location, and merit.

Other Benefits Include

• Medical, Dental & Vision Insurance, Basic and Voluntary Life and AD&D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Account, Health Savings Account, and Employee Assistance Programs
• Discretionary Bonus Programs and Long-term Incentive Plan
• Retirement Savings 401k with company match
• Generous Paid Time Off, Sick Time & Paid Holidays
• Career Development, Progression and Training
• Flexible Work Arrangement Programs
• Paid Parental Leave
• Year-End Paid Holiday Shutdown

NS Pharma is an EEO employer.