The Immuno-oncology Precision Medicine Director IO-(PMD),is responsible for directing the scientific aspects of translational medicine correlative studies in Immune Oncology. The successful candidate will be responsible for contributing to translational development strategies for the NVS IO portfolio. Expertise in developing biomarkers and assays for clinical trials, and a strong knowledge in immunology and tumor biology is required.. The IO-PMD, in collaboration with the PMLs, leads and oversees all aspects of implementation and execution of the immuno-oncology OPM strategy, with predominant focus on timely execution of biomarker activities to support decision making in the GPT.
1. Functionally and operationally reports to the VP, Global Head of Translational Precision Oncology (TPO-CoE) Center of Excellence
2. In collaboration with the PMLs, contributes to the design of the disease adapted immune-oncology OPM strategy in support of a several GPTs. In collaboration with the PMLs, is responsible for the implementation & execution of the immune oncology strategy
3. Must have In-depth knowledge of fundamentals of immunology, immune oncology, and tumor biology in solid and hematological malignancies
4. Utilization of translational based approaches to develop new concepts and mechanism of action hypotheses identifying distinguishing characteristic of Novartis compounds alone and in combination with other therapies
5. Knowledge of biomarker discovery and development: assay development/validation, clinical discovery of biomarkers, MoA research, knowledge of platforms
6. Ensures timely execution of assay development for patient selection, stratification, pharmacodynamics, correlative studies and CDx development for clinical trials by working with internal stakeholders (global line functions and PMLs) and external partners (clinical research organizations, Academic Labs, clinical labs and diagnostic partners) for assigned program(s) with limited oversight
7. In collaboration with TCO/NIBR, identify and validate external laboratories involved in CTAs for clinical trials and companion diagnostic development.
8. Authors the biomarker/CDx portions of key IO clinical documents including Clinical Development Plan, Clinical Study Protocols, Investigator Brochures, and Clinical Study Reports (CSRs)
9. 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.
10. Actively educates other team members through knowledge sharing. Contributes to the development and implementation of processes supporting patient pre-selection and stratification, pharmacodynamic monitoring,correlative studies & requirements for CDx development for immune-oncology
11. Acts as core member of the IO CoE
12. Avoids strategic and operational crises by proactively identifying and managing potential risks to the program(s). In case issues cannot be avoided, ensures that they are being resolved employing the full technical and strategic expertise and experience of the organization thus limiting negative impact on the program(s)
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Doctorate in immunology, immune-oncology, tumor biology or cellular biology,
Fluent English (written and oral),
1. At least 3 years of successful post-doctoral experience, evidenced by a strong publication record, plus a minimum of 2 years of successful experience in the biotechnology or pharmaceutical industry setting
- Expertise in developing biomarkers for clinical trials, and strong knowledge in immunology and tumor biology, knowledge of hematopoetic malignancies desired
- Relevant skills include proficiency in immunological techniques (flow cytometry, intracellular staining, cytotoxicity assays, ELISA, ELISpot, IHC, etc.), and molecular biology Proven people leadership capabilities
2. Model natural leadership characteristics
3. Strong interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective international collaboration.
4. Outstanding verbal and written communications.
5. Diagnostic experience is an advantage
6. Results driven