DIRECTOR, QUANTITATIVE PHARMACOLOGY AND PHARMACOMETRICS

2 weeks ago

IN United States Merck Full time
**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. 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 into programs, comparator modeling, thereby strengthening our 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.

+ 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 four years of pharmaceutical drug development experience relating to: PKPD, pharmacometrics, mathematics, statistics/ biostatistics, or chemical/biomedical engineering.

+ Masters or PharmD, with at least six 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 impactful experience 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 or other similar programing language.

+ Professional working proficiency in written and verbal communication.

_This (remote) position is only applicable for those that are not within commutable distance to primary sites noted in posting. If commutable, please see requisition #R277875. Please note that standard commute is (less than)

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