Director, Quantitative Pharmacology and Pharmacometrics – Oncology

MSD • Upper Gwynedd Township, PA

4d • $190,800 - $300,300 • Hybrid

About The Position

We are seeking an experienced talented scientist to join the Quantitative 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.

Requirements

• 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.
• 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.

Nice To Haves

• Antibody Drug Conjugates (ADC)
• Biologics
• Oncology
• Small Molecule Drugs
• T Cells

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.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree