Associate Director, Precision Medicine Strategy Lead

We are seeking to hire a Precision Medicine Strategy Lead (PMSL) to oversee the development and execution of biomarker strategies for Genetic Medicines involving novel therapeutic modalities across multiple disease areas including rare genetic disorders and / or neurodegenerative conditions.

In this highly matrixed role, they will design, develop, communicate at senior levels and operationally implement clinical biomarker strategies to support select, 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.

As an Associate Director, a typical day may include the following :

Program-level PM lead for implementation of strategic vision for clinical biomarkers in one or more therapeutic areas 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 on development teams and delivers 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)

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;

Represent Regeneron and work with colleagues from allied companies to develop and implement strategies for partnered alliances

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, BioAnalysis, etc.

to develop plan for validation and application of research assays

Contribute to and ensure the quality of technical reports, study memos and clinical study reports, data reviews and interpretations, scientific publications and recommendations to development teams and management

This role may be for you if :

The ability to drive, manage, complete and deliver results for complex multi-functional projects

Excellent communication and presentation skills and high emotional intelligence, organizational skills and effective team skills

To be considered for this role, you must have a PhD and 10 years of experience participating effectively on cross-disciplinary teams in pharmaceutical or biotech industry.

We need at least 3 years in clinical assay development, validation and implementation, with a track record of high impact in drug development.