Scientist, Precision Medicine

As a Scientist you will work with your manager to design and execute biomarker strategies for clinical trials within drug development for our Neuroscience or Neurodegenerative diseases programs. We develop and operationally implement biomarker strategies to support both early and late stage drug development trials.

You will act as a study-level Precision Medicine representative for the implementation of strategies within one or more projects/programs. This will enable our advances in confirming target engagement, pharmacodynamic effects, indication selection, early indication of biological activity and patient stratification/selection within studies and programs.

A typical day may include:

• Reviewing fundamental training and periodically rolled-out training in clinical development, precision medicine, SOPs and regulatory guidance's. The goal is to build a knowledge base for designing and implementing precision medicine studies.

• Conducting detailed literature and technology reviews related to specific assay needs for a given target molecule as it approaches and enters the clinic, collaborating with specialists in disease areas, and learning to navigate the logistical and regulatory factors pertaining to implementation of clinical technologies.

• Interacting with Precision Medicine operations, Research colleagues, (e.g. Discovery Research, Molecular Profiling, DNA Core, Regeneron Genetics Center), clinical operations, colleagues from allied companies (as appropriate), and colleagues within all stages of clinical development. In close collaboration with PM Ops you will interact with central labs to set up biomarker assays for clinical studies, as well as setting up independent experimental studies with appropriate vendors to answer urgent technical and scientific questions of interest to studies (biomarker stability, method deviations etc).

You will participate on selected teams and sub-teams as appropriate to ensure PM strategies are well articulated and incorporated successfully into development programs and will contribute to and participate on presentations to development team leadership. You will work with quantitative scientists within PM to analyze and interpret data from implemented biomarker studies.

KEY ACTIVITIES INCLUDE:
With guidance from direct management, interacting with operations partner and laboratories (internal, 3rd party or CROs) to ensure clinical assays are developed and validated according to fit-for-purpose (whether internal or external)

Closely collaborating with PMQS to deliver timely results from biomarker studies to individual project teams.

Contributing to sections of Precision Medicine technical reports, study memos and clinical study reports, data reviews and interpretations, scientific publications and recommendations to development teams and management.

This may be for you if:

• Ability to drive, execute and deliver results for multiple projects required
• Like to work cross-functionally to with across various teams in various stages of drug development.
• Want to see the impact of your work on patients

To be considered for this position you should have a Ph.D. or an M.D. plus post-doctoral experience of relevance. Experience in Neuroscience and/or Neurodegenerative Diseases research and/or drug development is required. Experience in basic, translational or clinical research related to biomarkers, pharmacogenetics, imaging, and/or other clinical technologies preferred. Basic understanding of technical, regulatory, clinical, and strategic aspects of these areas strongly recommended.