Pharmacometrics Strategy Lead, Clinical Pharmacology MIDD

Clinical Dynamix, Inc.; San Diego (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Travel <10%

Competitive compensation

Job summary

Clinical Dynamix, Inc. is seeking an Associate Director, Pharmacometrics to design and lead modeling & simulation across late-stage programs in a fast-paced biopharma setting.

The role emphasizes MIDD approaches, PK/PD modeling, exposure–response analyses, and regulatory submissions, with NLME methods and hands-on NONMEM/R experience.

Candidates should have a PhD/PharmD and 4+ years of industry experience; travel <10% is required.

Qualifications

• PhD or PharmD in Pharmaceutical sciences, Clinical Pharmacology, Mathematics, Statistics, Engineering (or equivalent) required.
• 4+ years of relevant industry experience including NLME methods and its application in Dose-exposure-response analysis, population PK/PD modeling, disease progression modeling and clinical trial simulation.
• Clinical pharmacology, statistics and therapeutic knowledge in one or more disease areas.
• Experience with incorporation of MIDD strategies into drug development across all phases and responding to questions on dose and regimen justification, study design among others.
• Hands-on experience with at least NONMEM and R is strongly preferred.

Responsibilities

• Developing and executing modeling and simulation strategies from the early through late-stage clinical development and serve as the SME in cross-functional development program teams.
• Delivering strategic and well-timed modeling input at key decision points along the development path.
• Set the strategy for addressing pharmacometric issues in regulatory submissions and directly influences drug development decisions.
• Lead and drive PMX contributions to integrate relevant technical and scientific knowledge in the planning and execution of robust quantitative development programs with focus on MIDD strategies.
• Use state of the art modeling and simulation approaches to interpret PK/PD data and accountable and responsible for ensuring appropriate PK-PD analysis including population PK, PK-PD modeling and simulation, and exposure-response analysis.
• Guide empirical modeling/QSP approaches to understand relationship between PK, biomarkers and disease outcomes undefined.

Skills

NLME methods

Dose-Exposure-Response

Population PK/PD

MIDD strategies

NONMEM

R

Clinical pharmacology

PK-PD modeling

Regulatory submissions

Data analysis & interpretation

Education

PhD/PharmD

4+ years industry experience

MIDD experience

Tools

NONMEM

R

Job description

Clinical Dynamix, Inc. is seeking an Associate Director, Pharmacometrics to design and lead modeling & simulation across late-stage programs in a fast-paced biopharma setting.

The role emphasizes MIDD approaches, PK/PD modeling, exposure–response analyses, and regulatory submissions, with NLME methods and hands-on NONMEM/R experience.

Candidates should have a PhD/PharmD and 4+ years of industry experience; travel <10% is required.