Director Precision Medicine

The Precision Medicine group at Regeneron is responsible for designing, implementing, executing, analyzing and interpreting the overarching clinical biomarker strategies for therapeutic candidates during clinical development. We are seeking to hire a hands‑on Precision Medicine Strategy Lead (PMSL) roles at the director level, with backgrounds in one or more therapeutic areas within the group. We are seeking someone to independently oversee the development and execution of biomarker strategies across one (or more) therapeutic areas depending on their areas of expertise, with a preference in obesity / metabolism pharmaceutical development.

The following therapeutic areas are in scope:
Neurodegenerative Disorders, Cardiovascular Disease, Muscle and Metabolism Disorders, and/or Rare Genetic Diseases. In this highly matrixed role, they will design, develop, communicate at senior levels and operationally implement clinical biomarker strategies to support key programs in early and late stage drug development. Clinical technologies applied include biomarker assays, pharmacogenetic assessments, as well as other clinical and physiological testing devices.

• Enhancing our understanding of indications at a cellular and molecular level
• Conducting novel biomarker discovery, qualifying new biomarkers/approaches to expedite proof‑of‑concept for new drug candidates.
• Optimizing label claims for later stage candidates, enabling personalized medicine principles to be applied, as appropriate, in full development.
• With a focus in therapeutic areas outside of Oncology, broad understanding of disparate biomarker technologies, and deep experience in biomarker assay development and validation in clinical drug development
• Responsible for conducting in‑depth literature and technology reviews pertinent to assigned clinical development programs within the TFA, identifying and pulling in experts in multiple disease areas, navigating and supporting the logistical and regulatory factors pertaining to clinical technologies.

• TA‑level lead for implementation of strategic vision for clinical biomarkers in one or more therapeutic areas across multiple programs with multiple studies that will broadly enable advances in target identification, indication selection, early indication of biological activity and patient stratification/selection
• Serve as an individual contributor and senior‑level representative of Precision Medicine on development teams and deliver biomarker strategies to key programs from initial concept to execution, data delivery and results interpretation
• Collaborate with Discovery Research and product development teams to facilitate appropriate incorporation of Precision Medicine and clinical biomarker strategies for molecules in discovery phases (leading to candidate molecule selection)
• Represent Regeneron and work with colleagues from allied companies to develop and implement strategies for partnered alliances
• Collaborate with clinical operations teams to implement specific biomarker and exploratory sample collection and analyses in all relevant clinical studies in selected programs
• Design, oversee and manage internal and external research collaborations in areas of clinical technologies and translational research
• Accountability for ensuring complex clinical assays used in programs in the TFA portfolio of clinical development are fit‑for‑purpose (whether developed and validated internally or externally)
• Collaborate with internal Regeneron laboratories (e.g. Discovery Research, Molecular Profiling, Regeneron Genetics Center, DNA core, Bio Analysis, etc.) to develop plan for validation and application of research assays
• Ensure timely delivery of results across selected programs, consistent with program team and senior management expectations in a way that increases the potential impact of Precision Medicine deliverables on Global Development programs
• Contribute to and ensure the quality of Precision Medicine technical reports, study memos and clinical study reports, data reviews and interpretations, scientific publications and…