Director – Precision Medicine – Companion Diagnostics
| Company | Regeneron Pharmaceuticals |
|---|---|
| Location | Westchester County, NY, USA, Berkeley Heights, NJ, USA |
| Salary | $198000 – $330000 |
| Type | Full-Time |
| Degrees | PhD, MD |
| Experience Level | Expert or higher |
Requirements
- Ph.D. and/or M.D
- Minimum of 10 years postdoctoral experience in matrix interaction preferably in a pharmaceutical or biotech industry, or in academic or governmental cross-disciplinary teams
- Extensive experience in diagnostic development with demonstrated success in a drug development setting
- Strong understanding of technical, regulatory, clinical, and strategic aspects of diagnostic delivery
- CDx knowledge
- Demonstrated deep knowledge in science and technology
- Demonstrated experience in delivering diagnostics
- Contributes to and reviews documents pertaining to regulatory interactions and filings related to Precision Medicine, including product labeling
Responsibilities
- Define innovative diagnostic strategies and propose projects from idea to implementation
- Develop strong relationships partnerships with IVD partners and testing laboratories
- Oversee operational aspects of CDx clinical trial implementation, manage timelines and communicate effectively both externally and internally
- Support regulatory teams surrounding CDx (from study set up to PMA filing)
- Be viewed as a subject matter expert in oncology and communicate with clinical study teams on program direction
- Define and drive CDx strategy and gain alignment across relevant partners
- Lead execution and implementation of Regeneron CDx strategy in collaboration with key partners
- Evaluate and make decisions on technologies and vendors as needed to support diagnostic and program deliverables
- Provide testing site implementation and oversight for CDx programs from contracting to sample logistics to data delivery
Preferred Qualifications
- Strong leadership tendencies
- Ability to proactively identify problems, determine resolutions, set priorities, and direct projects
- Excellent communication and collaborative skills
- High level of emotional intelligence
- Ability to work collaboratively with colleagues, vendors and internally at Regeneron