The Oncology Precision Medicine Principal Scientist is responsible for directing scientific aspects of biomarker and IVD development related to the Immuno Oncology portfolio. The successful OPM Immuno Oncology Principal Scientist will be able to lead and implement projects cross-functionally both within Novartis and with external partners. The predominant focus will be on timely execution of biomarker activities and IVD development to support the NVS IO assets. Expertise in biomarker and IVD development for oncology clinical trials is required.
1. Functionally reports to the Global Head of Immuno-Oncology Biomarker diagnostic Center of Excellence (IO-CoE). Operationally reports to the OPM IO Director.
2. Responsible for identifying, prioritizing, and recommending key IO biomarkers and diagnostics applicable to Novartis IO assets.
3. Responsible for executing feasibility biomarker and diagnostic studies to support Novartis IO assets.
4. Identifying critical signaling pathways and mechanisms of actions associated with IO therapy response and resistance that are common and unique across indications.
5. Lead the harmonization of IO biomarker testing across indications.
6. Support Precision Medicine Directors and Associate directors in the development of biomarker plans.
7. Support the creation of biomarker/CDx portions of key IO clinical documents including Clinical Development Plan, Clinical Study Protocols, Investigator Brochures, and Clinical Study Reports (CSRs)
8. Supports regulatory submissions by acting as subject matter expert within the team. Contributes scientific and technical sections of key regulatory documents including INDs, FDA briefing books, and submission documents (including NDAs, IDEs & PMAs). Coordinates data requirements with reference labs to support submission.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
PhD or Masters in molecular biology, immunology, immune-oncology, tumor biology, cellular biology, or related field.
Fluent English (written and oral),
1. 5+ years of industry experience in biomarker development
2. 5+ years multi/cross functional experience within an Oncology business unit.
3. Expert management and communication skills to coordinate cross-functional projects.
4. Strong interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective international collaboration.
5. Outstanding verbal and written communications.
6. IVD development experience is an advantage
7. Results driven