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

Merck; Rahway (NJ); Remote; USD 120,000 - 180,000; Full time

Job summary

An established industry player is looking for a Director of Quantitative Systems Pharmacology to join their innovative team focused on drug development in oncology. This role involves leading the development of mechanistic models and strategies that enhance decision-making in clinical trials. The ideal candidate will have a strong background in pharmacometrics and systems biology, coupled with excellent leadership and communication skills. Join a collaborative environment where your expertise will directly impact the advancement of novel therapies, driving the future of healthcare and improving patient outcomes.

Qualifications

• Ph.D. with 7+ years in pharmaceutical drug development or Masters/PharmD with 9+ years.
• Expertise in developing mechanistic PK-PD and QSP models for clinical development.

Responsibilities

• Lead model-based analyses for drug development, enhancing quantitative decision-making.
• Collaborate with cross-functional teams to optimize clinical trial designs.

Skills

Mechanistic PK-PD modeling

Quantitative Systems Pharmacology (QSP)

Experimental design

Mathematical problem solving

Data analysis and interpretation

Statistics

Communication skills

Education

Ph.D. in a relevant field

Masters or PharmD

Tools

MATLAB

R

SimBiology

C/C++

NONMEM

WINNONLIN

Job description

Job Description

Role and Responsibilities:

We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (QP2-IO) team in the role of Director, Quantitative Systems Pharmacology (QSP). QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology, mechanistic PK-PD modeling and pharmacometrics of oncology drugs from post-PCC to registration. Directors are leaders in the field of quantitative drug development, with a strong, integrated understanding of the strategic elements of drug development. As a subject matter expert, the Director within the QP2-IO Group will work closely with teams of highly collaborative, cross-functional scientists to contribute to development of novel chemical entities. They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. Directors demonstrate outstanding leadership and communication skills. 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 of drug development teams.

Primary Responsibilities:

• Serving as a QSP expert for QP2 -IO for developing and executing model-based analyses including QSP models and mechanistic PK/PD models into programs thereby strengthening our quantitative capabilities on a continuous basis in decision making and driving pipeline impact.
• Assisting asset development teams in bringing forward combination drug approaches by leveraging QSP models to design and prioritize combination clinical trials
• Broad understanding of population pharmacokinetic models and exposure-response models for application in clinical development
• Work in close collaboration with biologists, clinicians, clinical pharmacologists, pharmacometricians and other line functions to improve our understanding of disease mechanisms and modalities
• Framing critical questions and strategy for optimizing model-based analyses on programs.
• Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics (monoclonal antibodies, antibody drug conjugates, T-cell engagers, bispecifics) 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 at least seven years of pharmaceutical drug development experience relating to: systems biology, PKPD, pharmacometrics, mathematics, chemical/biomedical engineering or related field.
• Masters or PharmD, with at least nine years of experience, where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development.

Required Experience:

• Experience in developing mechanistic PK-PD models and QSP models for decision making in early and/or late-stage clinical development
• Experience with mechanistic modeling for antibody drug conjugates (ADCs) and/ or T-cell engagers will be preferred
• Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
• Experience with modeling and simulation packages or programming languages (e.g., MATLAB, R, SimBiology, C/C++)
• Experience working with external QSP vendors
• Familiarity with R, NONMEM, WINNONLIN or other similar programing language
• Professional working proficiency in written and verbal communication.
• Experience in IND, NDA and other submissions to global regulatory agencies.
• An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches.