The Oncology Precision Medicine Immuno Oncology Director is responsible for implementing 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 a team of scientists to implement all aspects of the immuno-oncology OPM strategy across diverse cancer indications. Recognized expertise in immunology, 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 implementing the overarching OPM IO biomarker and diagnostics strategy across all GDD IO indications
3.Responsible for managing all OPM IO CoE associates (excluding in situ diagnostics lab group that is managed by in situ diagnostics lab director) and developing the career paths of principal scientists and scientists in the group.
4.Responsible for leading the IO scientific team in providing creative solutions to complex issues leading to the successful the implementation & execution of IO biomarkers and IVD development including life cycle management.
5.Is the interface between the OPM IO group and In situ diagnostics Director, FPM and TPO directors. Will lead collaborative efforts between these team members and with both external partners (clinical research organizations, Academic Labs, clinical labs, pathologists, and diagnostic partners) and internal partners (TCO, NIBR, OTR groups).
6.Accountable for the identification and validation of all IO external laboratories involved in CTAs for IO GDD clinical trials and companion diagnostic development.
7.Responsible for ensuring sufficient support is provided to enable timely execution of assay development for patient selection, stratification, pharmacodynamics, correlative studies and CDx development for GDD IO trials.
8.Is responsible for educating OPM and Novartis associates on IO biomarkers and diagnostics.
9.Accountable for providing the resources needed to support the biomarker/CDx portions of key IO diagnostic documents including scientific and technical sections of key regulatory documents such as INDs, FDA briefing books, NDAs, IDEs & PMAs.
10.Leads the IO CoE team to proactively identify, manage, and come up with solutions to potential risks to the IO program(s) that can impact both short term and mid-term programs.
11.Contributes to the development, implementation and continuous improvement of processes supporting the OPM vision, mission and goals.
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.
Doctorate or Masters in molecular biology, immunology, immune-oncology, tumor biology, cellular biology, or related field.
Fluent English (written and oral),
1.5+ years drug/diagnostic development, or equivalent clinical laboratory, experience
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.Excellent 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.CLIA laboratory/IVD development experience is an advantage
8.Immunology/Immuno-oncology experience is an advantage
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