Remote Associate Director Quantitative Clinical Pharmacology

Simulations Plus; Northern (KY); Hybrid; USD 135,000 - 175,000; Full time

Benefits offered by this job

Fully remote work

Flexible schedules

Generous vacation policy

Health coverage

Annual bonus

Job summary

Simulations Plus is seeking an Associate Director, Quantitative Clinical Pharmacology to lead multi-disciplinary teams through client goals, oversee study design, modeling, simulations and the presentation of results.

Responsibilities include PBPK, population PK, PK/PD modeling, regulatory interactions with health authorities, mentoring junior scientists, and delivering regulatory documents and publications. This remote role offers flexible schedules, generous vacation and annual bonus.

Qualifications

• 6+ years of applied clinical pharmacology experience preferred.
• 4+ years of leading projects, programs, and scientists preferred.
• Experience supervising junior staff preferred.
• Experience presenting scientific results to professional audiences.
• Publications in scientific journals preferred.

Responsibilities

• Lead multi-disciplinary project teams to implement quantitative clinical pharmacology projects and provide consultation.
• Support study protocols, data analysis, and report writing with colleagues.
• Participate in regulatory interactions with health authorities.
• Provide modeling and simulation using PBPK, population PK, PK/PD, and exposure–response analyses with various tools.
• Mentor junior scientists and share findings across teams.
• Prepare final technical reports and regulatory documents.
• Stay current with pharmacometric literature and attend conferences.

Skills

Clinical pharmacology

Project leadership

Regulatory interaction

PBPK modeling

PK/PD modeling

Education

PharmD/PhD/MS in pharmacokinetics

Tools

GastroPlus

MONOLIXSuite

NONMEM

R

Job description

Simulations Plus is seeking an Associate Director, Quantitative Clinical Pharmacology to lead multi-disciplinary teams through client goals, oversee study design, modeling, simulations and the presentation of results.

Responsibilities include PBPK, population PK, PK/PD modeling, regulatory interactions with health authorities, mentoring junior scientists, and delivering regulatory documents and publications. This remote role offers flexible schedules, generous vacation and annual bonus.