R333126 Associate Director, Quantitative Pharmacology and Pharmacometrics, Immune/Oncology (Remote)

Merck; Rahway (NJ); Remote; USD 153,000 - 243,000; Full time

Job summary

An established industry player is seeking an Associate Director to join their dynamic Quantitative Pharmacology and Pharmacometrics team. This role involves leading innovative strategies for quantitative analyses in oncology drug development, collaborating with cross-functional teams, and ensuring compliance with global regulatory expectations. The ideal candidate will possess a Ph.D. or equivalent experience in pharmaceutical drug development, with a strong background in pharmacometrics and data analysis. This position offers the opportunity to make a significant impact on drug development strategies while enjoying a flexible work arrangement. Join a forward-thinking organization where your expertise will drive meaningful advancements in healthcare.

Benefits

Bonus eligibility

Health care benefits

Retirement benefits

Paid holidays

Vacation

Sick days

Qualifications

• Ph.D. with 3 years of drug development experience or Masters/PharmD with 3-5 years.
• Expertise in pharmacometrics methods and quantitative analyses.

Responsibilities

• Serve as an expert representative for QP2-IO on clinical development teams.
• Develop and execute model-based analyses to strengthen pharmacometrics capabilities.

Skills

Pharmacometrics methods

Experimental design

Mathematical problem solving

Critical data analysis

Statistics

Communication skills

Education

Ph.D. in related field

Masters or PharmD

Tools

R

NONMEM

Job description

Job Description

We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (QP2-IO) team in the role of Associate Director. The QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration.

Associate Directors are emerging leaders in the field of quantitative drug development, with a developing understanding of the strategic elements of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams of highly collaborative, cross-functional scientists to contribute to the development of novel chemical entities. They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. They collaborate within QP2-IO and with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative framework to impact strategies and decisions on drug development teams.

Primary Responsibilities:

• Serving as an expert representative for QP2-IO on Oncology clinical development teams.
• Framing critical questions for optimizing model-based analyses on programs.
• Developing and executing model-based analyses including translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, and comparator modeling, thereby strengthening pharmacometrics capabilities on a continuous basis in decision making and driving pipeline impact.
• Strategizing and executing modeling of tumor size and survival endpoints including proportional hazards models.
• Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs)), and representing QP2-IO at regulatory meetings.

Minimum education required:

• Ph.D. with approximately 3 years of pharmaceutical drug development experience relating to: PKPD, pharmacometrics, mathematics, statistics/biostatistics, or chemical/biomedical engineering.
• Masters or PharmD with 3-5 years of experience, where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development.

Required Experience:

• Demonstrated impactful experience with applications of pharmacometrics methods.
• Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
• Proficiency in R, NONMEM or other similar programming/modeling software.
• Professional working proficiency in written and verbal communication.

Salary Range: $153,800.00 - $242,200.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: Yes

Travel Requirements: 10%

Flexible Work Arrangements: Remote

Job Posting End Date: 05/16/2025

Requisition ID: R344528