2005! That's the year that Novartis began exploring Precision Medicine to extend and improve the lives of patients, by enabling the regulatory approval and commercial sale of transformative therapies.
Precision Medicine (PM) is an approach for prevention, diagnosis, treatment, and monitoring of disease that considers individual variability in biology, environment, and lifestyle for each person (source: NIH). Patient biomarker data and diagnostic assays drive healthcare decision-making by helping physicians identify patients for the right treatment and monitor their disease. Beyond biomarkers and companion diagnostics, precision medicine supports the Novartis pipeline by facilitating clinical trial design and execution, accelerating drug development, and informing early pipeline choices. By using advances in biology, technology, and data & digital solutions, Novartis Precision Medicine continues to innovate in our quest to disrupt treatment paradigms and reimagine medicine.
The Diagnostic Sciences principal scientist (DxSc) is a core member of the Diagnostics Sciences and Partnerships group. The DxSc is responsible for providing technical inputs to define and execute the precision medicine biomarker and diagnostic strategy during clinical development. The DxSc works with internal stakeholders and external partners to support patient selection, companion diagnostic development, and submission of Novartis therapies.
Your responsibilities include, but are not limited to:
- Direct technical project teams on biomarker assay development in compliance with appropriate SOPs, WIs, Novartis qualifications, and relevant regulatory guidelines. Includes planning and initiating new projects, providing scientific input, monitoring the progress of on-going projects, and evaluating the outcomes
- Evaluate the technical aspects of a diagnostic biomarker assay and make recommendations of technology and vendor selection jointly with cross-functional teams.
- Oversee the interpretation of data, critically evaluate team conclusions, and direct preparation of reports generated by teams
- Represent Novartis during co-development of diagnostic assays with external vendors
- Provide leadership in solving scientific/technical problems and initiating new project concepts
- Communicate and present scientific/technical results at internal and external meetings
- Work closely with interdisciplinary teams to collaboratively resolve issues
What you'll bring to the role:
- PhD (USA) or equivalent in scientific discipline such as biology, chemistry, pharmacology with at least 3 years of appropriate and relevant experience in field; or MS (USA) or equivalent with at least 6 years of appropriate and relevant experience in field; or BS (USA) or equivalent with at least 8 years of appropriate and relevant experience in field.
- Possess excellent scientific reasoning abilities and a growth mindset
- Able to demonstrate strong communication skills; including interpersonal, verbal and writing skills and to convey information in a clear and concise manner
- Have a full understanding of applicable regulations and standards for medical device development and relevant diagnostic development.
- Be an excellent leader in a multidisciplinary environment, capable of multi-tasking, and able to be fully committed to development timelines
- Expertise in diagnostic development for protein markers is an advantage