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

Job Description

Director QP2-IO

We are seeking an experienced talented scientist to join theQuantitative Pharmacology and Pharmacometrics –Immune/Oncology(QP2-IO)team in the role of Director. 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 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.

Expected US salary range:

$187,000.00 - $294,400.00

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: Domestic/International

VISA Sponsorship: Yes

Travel Requirements: 10%

Flexible Work Arrangements: Hybrid

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): N/A

Job Posting End Date: 04/30/2025

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R332890