Director/Associate Director, Pharmacometrics
NS Pharma Inc
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.
Job description
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.
- 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.
- 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.
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.
- Manage and oversee pharmacometric activities conducted by external consultants, vendors, and CRO partners.
- Monitor emerging scientific and regulatory developments relevant to pharmacometrics and MIDD.
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.
- Demonstrated experience establishing, maintaining, and continuously improving pharmacometrics infrastructure, systems, tools, workflows, and quality processes.
- 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.
- Experience managing external consultants, vendors, and CRO partnerships.
- Demonstrated ability to mentor and develop scientists in pharmacometrics and quantitative drug development.
Requirements
- Deep understanding of clinical development, clinical pharmacology, pharmacometrics, and MIDD
- Hands-on experience with NONMEM, R, Simcyp, and other pharmacometric software
- Demonstrated hands-on experience independently conducting pharmacometric analyses from planning through regulatory application
- Demonstrated experience establishing and improving pharmacometrics infrastructure, systems, tools, workflows, and quality processes
- Demonstrated technical leadership, scientific judgment, and ability to communicate and influence stakeholders in a matrix environment
- PhD, PharmD, MS, or equivalent advanced degree in clinical pharmacology, pharmacometrics, pharmacokinetics, pharmaceutical sciences, statistics, applied mathematics, engineering, or related quantitative discipline
- Typically 10+ years (Associate Director) or 12+ years (Director) of relevant industry experience in pharmacometrics
- Demonstrated experience applying pharmacometrics to support development programs from early clinical development through regulatory approval
- Experience managing external consultants, vendors, and CRO partnerships
- Demonstrated ability to mentor and develop scientists in pharmacometrics and quantitative drug development
Benefits
- Medical, Dental & Vision
- Life & AD&D Insurance
- Short- & Long-Term Disability
- Flexible Spending Account
- Health Savings Account
- Employee Assistance Programs
- Discretionary Bonus Programs
- Long-term Incentive Plan
- 401(k) Matching
- Paid Time Off
- Sick Time
- Paid Holidays
- Career Development
- Training
- Flexible Work Arrangement
- Paid Parental Leave
- Year-End Holiday Shutdown
Company overview
NS Pharma, Inc. is a biopharmaceutical company specializing in the development and commercialization of innovative therapies for rare and complex diseases. Established in 1999 as a wholly-owned subsidiary of Nippon Shinyaku Co., Ltd., the company is headquartered in Paramus, New Jersey. NS Pharma focuses on delivering life-changing care to patients with debilitating genetic disorders, particularly in the areas of Duchenne muscular dystrophy (DMD) and Hunter Syndrome. The company leverages over 100 years of Nippon Shinyaku's development expertise to advance novel treatments through clinical development and commercialization. NS Pharma serves as a strategic bridge connecting Japan/Asia with global markets, developing drug candidates invented in Japan and out-licensing them internationally. The company's pipeline includes promising compounds like NS-229 for Eosinophilic Granulomatosis with Polyangiitis (EGPA) and NS-051/NCNP-04 for Duchenne muscular dystrophy, both of which have received FDA orphan drug designations. With approximately 124 employees, NS Pharma maintains a strong commitment to addressing unmet medical needs through scientific innovation and patient-centered approaches.