The Oncology Precision Medicine Director is responsible for directing the strategic and scientific aspects of biomarker and IVD development related to the Immuno Oncology portfolio. The successful OPM Immuno Oncology Director will lead and oversee all aspects of implementation and execution of the immuno-oncology OPM strategy, with predominant focus 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 and operationally reports to the Global Head of Immuno-Oncology Biomarker diagnostic Center of Excellence (IO-CoE)
2. Responsible for driving the overarching OPM IO biomarker and diagnostics strategy
3. Responsible for managing and impacting the career path of the OPM IO CoE including directors, associate directors, and principal scientists.
4. Responsible for leading the implementation & execution of IO biomarkers and IVD development including life cycle management.
5. Leads the collaboration efforts of the OPM IO CoE with both external partners (clinical research organizations, Academic Labs, clinical labs and diagnostic partners) and internal partners (TCO, NIBR, Exploratory IO groups).
6. Accountable for the identification and validation of external laboratories involved in CTAs for IO clinical trials and companion diagnostic development.
7. Responsible for ensuring timely execution of assay development for patient selection, stratification, pharmacodynamics, correlative studies and CDx development.
8. Is responsible for educating OPM and Novartis associates on IO biomarkers and diagnostics.
9. Accountable for the biomarker/CDx portions of key IO clinical documents including Clinical Development Plan, Clinical Study Protocols, Investigator Brochures, and Clinical Study Reports (CSRs)
10. 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.
11. Leads the IO CoE team to proactively identify and manage potential risks to the IO program(s).
EEO Statement 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 leadership experience within an Oncology business unit.
3. Proven people leadership capabilities in staff management role or in other organizational assignments.
4. Expert skills to facilitate/optimize contribution of team members as individuals and members of cohesive team.
5. Strong interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective international collaboration.
6. Outstanding verbal and written communications.
7. IVD development experience is an advantage
8. Results driven