Director, Pharmacometrics & MIDD Strategy

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

Benefits offered by this job

Medical/Dental/Vision insurance

401k with company match

Paid time off

Parental leave

Flexible work arrangements

Career development

Year-end holidays

Job summary

NS Pharma is a focused biopharmaceutical company seeking a pharmacometrics leader to guide model-informed drug development for rare diseases and oncology. You will lead quantitative strategy, PK/PD analyses, and mentorship across global teams, including the Japan organization, aligning with regulatory expectations.

This role emphasizes building capabilities, collaborating with Clinical Pharmacology, Biostatistics, and Regulatory Affairs, and managing external partners to deliver analyses and

Qualifications

• PhD, PharmD, MS, or equivalent 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.
• Experience applying pharmacometrics to support development programs, including population PK, PK/PD, exposure–response analyses, regulatory submissions.
• 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 study design.
• Lead pharmacometric analyses and provide guidance for design, interpretation, and regulatory submissions across programs.
• Represent pharmacometrics on cross-functional teams, collaborating with Clinical Pharmacology, Biostatistics, DMPK, Discovery, and Regulatory Affairs.
• Oversee external vendors and CRO partners to ensure timely, high-quality analyses and regulatory documentation.
• Monitor scientific and regulatory developments in pharmacometrics and promote adoption of best practices.

Skills

Pharmacometrics

Clinical pharmacology

MIDD

NONMEM

R

Simcyp

Regulatory interactions

Education

PhD, PharmD, MS or equivalent

Tools

NONMEM

R

Simcyp

PBPK modeling

Job description

NS Pharma is a focused biopharmaceutical company seeking a pharmacometrics leader to guide model-informed drug development for rare diseases and oncology. You will lead quantitative strategy, PK/PD analyses, and mentorship across global teams, including the Japan organization, aligning with regulatory expectations.

This role emphasizes building capabilities, collaborating with Clinical Pharmacology, Biostatistics, and Regulatory Affairs, and managing external partners to deliver analyses and