Pharmacometric Strategy Director (MIDD)

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, 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.