Role Summary
The Associate Director in Precision Medicine leads clinical biomarker and translational efforts for Regeneron's Immunology & Inflammation (I&I) and Ophthalmology pipelines. They own the Precision Medicine strategy and biomarker programs, collaborating with clinical and research personnel to support development, accelerate proof-of-concept, and optimize label claims. The role involves cross-functional leadership, engagement with internal teams and external partners, and representation of Translational Medicine on strategic project teams.
Responsibilities
- Lead Precision Medicine (clinical biomarker) strategy development and execution to support the clinical development portfolio, including biomarker-driven clinical study design, implementation of novel technologies and incorporation of biomarker endpoints.
- Lead biomarker development and implementation through the application of genomic (RNA and DNA sequencing), protein and cell/tissue analysis, and clinical device technologies, as needed.
- Champion early-adoption of biomarker strategy for pipeline pre-clinical programs and generate proposals for clinical experimental sciences studies, in close collaboration with Clinical Sciences, I&I Research, and Regeneron Genetics Center (RGC) colleagues.
- Represent Precision Medicine on cross-functional strategic project teams and global clinical sub-teams across the development portfolio.
- Provide cross-functional team leadership of internal clinical biomarker discovery platform development (laboratory assays, computational biology methods), in collaboration with research, molecular profiling and genomics center teams.
- Present the clinical translational project plans, clinical trial protocols, biomarkers data and interpretation of results to internal stakeholders (including senior management), regulatory agencies and global opinion leaders, as needed.
- Evaluate emerging technologies and vendors to consider for future programs and to interpret data across programs.
- Willingness to work across multiple therapeutic areas, which may include but not be limited to Immunology & Inflammation, Ophthalmology and Infectious Disease.
Qualifications
- Required: PhD and 6+ years of experience participating effectively on cross-disciplinary teams in pharmaceutical or biotech industry.
- Preferred: Experience in clinical assay development, validation and implementation with strong experience in Immunology.
Skills
- Excellent communication and presentation skills and high emotional intelligence, organizational skills and effective team skills.
- Ability to drive, manage, complete and deliver results for complex multi-functional projects.
Education