Associate Director, Quantitative Pharmacology and Pharmacometrics – Immuno-Oncology (QP2‑IO)

Merck•Rahway, NJ

19h•$156,900 - $247,000•Hybrid

About The Position

Our company is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. We are recognized as an industry leader in immuno-oncology (IO) and vaccines discovery and development. For more than a century, our company has translated scientific innovation into medicines and vaccines that improve and save lives worldwide—anchored in ethical integrity, scientific excellence, and a clear mission to transform global health. Our company is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Our Research & Development Division is a world-class scientific organization that brings together leading discovery capabilities and small molecule/biologics R&D expertise to create breakthrough science and redefine how we treat serious diseases. 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 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 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.

Requirements

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 programing language.
Professional working proficiency in written and verbal communication.

Nice To Haves

NONMEM
Oncology
Oncology Drug Development
Phoenix WinNonlin
PKPD Modeling
Population Pharmacokinetics
Regulatory Writing

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, 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.