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

MSD; Boston (MA); Remote; USD 120,000 - 200,000; Full time

Job summary

An established industry player is looking for a Director to lead the Quantitative Pharmacology and Pharmacometrics team focused on oncology drug development. This role involves strategic oversight of model-based analyses, regulatory submissions, and mentoring junior scientists. The ideal candidate will have a strong background in pharmacometrics, excellent leadership skills, and a proven track record in drug development. Join a collaborative environment where your expertise will drive impactful decisions and contribute to the development of novel therapies that could change lives.

Qualifications

• 7+ years of experience in pharmaceutical drug development related to PKPD and pharmacometrics.
• Expertise in model-based analyses and regulatory submissions.

Responsibilities

• Lead quantitative analyses for oncology drug development and mentor junior staff.
• Collaborate with cross-functional teams to optimize drug development strategies.

Skills

Pharmacokinetics (PK)

Pharmacodynamics (PD)

Mathematics

Statistics/Biostatistics

Critical Data Analysis

Experimental Design

Model-Based Approaches

Communication Skills

Education

Ph.D. in relevant field

Masters or PharmD

Tools

R

NONMEM

MATLAB

Monolix

Job description

Job Description

Director QP2-IO

We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (QP2-IO) team in the role of 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. 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 the 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 an expert representative for QP2-IO on Oncology development teams.
• Framing critical questions and strategy 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 design simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, and comparator modeling.
• Strategizing and executing modeling of tumor size and survival.
• 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.
• Mentoring and/or supervising junior staff to perform the above duties and to develop the above capabilities.

Minimum education required:

• Ph.D. with at least seven years of pharmaceutical drug development experience relating to: PKPD, pharmacometrics, mathematics, statistics/biostatistics, or chemical/biomedical engineering.
• 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:

• Demonstrated impact with applications of pharmacometrics methods.
• Experience in IND, NDA and other submissions to global regulatory agencies.
• Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
• An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches.
• Proficiency in R, NONMEM, MATLAB, Monolix or other modeling software.
• Professional working proficiency in written and verbal communication.