Associate Director, Quantitative Systems Pharmacology - Oncology (Hybrid or Remote)

Merck; West Point (NE); Remote; USD 180,000 - 243,000; Full time

Job summary

A leading pharmaceutical company is seeking a QSP expert to develop and execute model-based analyses. The role involves collaborating with cross-functional teams to enhance understanding of clinical trials and disease mechanisms, offering opportunities for career advancement and remote work flexibility.

Benefits

Comprehensive benefits package

Eligible for annual bonus

Opportunity for career advancement

Collaborative work environment

Remote work flexibility

Qualifications

• At least four years of pharmaceutical drug development experience or six years for Master's/PharmD.
• Proven experience in PK-PD and QSP models.
• Professional proficiency in communication.

Responsibilities

• Develop and execute model-based analyses in QSP and PK/PD.
• Design and prioritize clinical trials using QSP models.
• Collaborate with cross-functional teams.

Skills

Experimental design

Mathematical problem-solving

Critical data analysis

Statistics

Verbal communication

Written communication

Education

Ph.D. in Pharmaceutical Development

Master's/PharmD with experience

Tools

MATLAB

R

Job description

Employer Industry: Pharmaceutical Development

Why consider this job opportunity:
- Salary up to $242,200
- Eligible for annual bonus and long-term incentives
- Comprehensive benefits package including medical, dental, vision, retirement benefits, paid holidays, and vacation
- Opportunity for career advancement and growth within the organization
- Collaborative work environment with cross-functional teams
- Remote work flexibility for candidates outside of commutable distance

What to Expect (Job Responsibilities):
- Serve as a QSP expert for developing and executing model-based analyses, including QSP and mechanistic PK/PD models
- Assist asset development teams in designing and prioritizing combination clinical trials using QSP models
- Collaborate closely with biologists, clinicians, and pharmacometricians to enhance understanding of disease mechanisms
- Frame critical questions and strategies for optimizing model-based analyses on programs
- Author regulatory documents and represent the QP2-IO team at regulatory meetings

What is Required (Qualifications):
- Ph.D. with at least four years of pharmaceutical drug development experience, or a Master's/PharmD with at least six years of experience
- Proven experience in developing mechanistic PK-PD and QSP models for clinical development
- Skills in experimental design, mathematical problem-solving, critical data analysis, and statistics
- Proficiency in modeling and simulation software or programming languages (e.g., MATLAB, R)
- Professional working proficiency in written and verbal communication

How to Stand Out (Preferred Qualifications):
- Experience with mechanistic modeling for antibody drug conjugates (ADCs), bispecifics, or T-cell engagers
- Familiarity with R NONMEM, WINNONLIN, or similar programming languages
- A record of increasing responsibility and independence in drug development decision-making

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