Accountable for ensuring that the overarching correlative sciences strategy is consistent across all disease area strategies and pertains to understanding patient selection/stratification, resistance and safety, in contribution to the Oncology Precision Medicine (OPM) strategy..
In collaboration with other OPM CoE leaders, designs the liquid biopsy strategy to enable patient selection for Oncology clinical studies and oversees the implementation of testing that covers ctDNA, exosomes and CTCs where appropriate. Will have significant global line function responsibilities including leading a major OPM function, initiatives, decision bodies.1. Member of the Oncology Precision Medicine (OPM) leadership team; functionally and operationally reports to the SVP, Global Head of OPM
2. Accountable for the design, implementation and execution of the end-to end precision medicine strategy in support of a global product team (GPT) that spans the product(s) value chain. This takes into account the discovery (w/NIBR & TCO), translation (OPM), regulatory and commercial components to deliver the PM strategy.
3. Contributes to the Development of the overarching Oncology Preci-sion Medicine (OPM) strategy, in collaboration with translational clinical oncology (TCO), Genoptix, and the Novartis Institute for Biomedical Research (NIBR). The overarching Precision Medicine Strategy will be end-to-end from discovery to commercial, so the TPO-CoE Leader will play a key role in leading the delivery of critical aspects of the strategy. Plays a key leadership role in developing and maintaining Internal & external Collaborations with key partners
4. Functional Manager of Precision Medicine Directors/Associate Direc-tors responsible for cross program aspects of precision medicine, in-cluding biomarkers, correlative science and CDx development, sup-porting the development of oncology agents.
5. Manages interface with TCO, Genoptix and NIBR for oncology correlative science studies, supporting preclinical studies and clinical biomarkers for pharmacodynamics, safety and monitoring and for prediction
prediction of efficacy.
6. Leads team to develop functional center of excellence in precision medicine execution by identifying and implementing best-in-industry practices. Develops and implements processes, standards, and tools to achieve excellence and improve productivity in all scientific and op-erational aspects of oncology precision medicine. Sets objectives ac-cording to provided standards and proactively manages performance in partnership with operational managers
7. Partners with TCO, and the leaders of the IO CDx CoE and NAT CDx CoE to develop common processes to identify and validate external la-boratories involved in CTAs for clinical trials and companion diagnostic development.
8. Partners with Outsourcing Management to develop standards and pro-cesses for identifying and selecting external labs and other vendors supporting correlative science studies.
9. Supports career development of associates in function through quality development plans. Identify individual training needs and ensures state of the art knowledge across the correlative science CoE to foster high levels of performance. Participate in the hiring, on-boarding, training and mentoring of new staff.
10. Develops standard processes for patient selection, stratification, phar-macodynamics and correlative studies for clinical trials by working with internal stakeholders (global line functions) and external partners (clinical research organizations and Academic Labs)
11. Establishes standards for correlative science related sections of key clinical documents including Clinical Development Plan, Clinical Study Protocols, Investigator Brochures, and Clinical Study Reports (CSRs)
12. Partners with other internal stakeholders to establish common process in all aspects of data collections and management including correlative science analysis plan, data formatting and transfer specifications, eCRF page design, and monitoring plans for correlative study samples.
13. Will play a leadership role for OPM line function (Talent recruitment, Compensation, etc)
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.
Ph.D with minimum 10 years experience in correlative science in Oncology, including biomarkers, of which a minimum of 5 years must be in Biotech/Pharmaceutical industry.
MD with a minimum of 10 years experience in development & implementation of patient selection and other correlative strategies for clinical programs and/or oncology clinical trial experience. Residency in a general medical field with additional subspecialty training, preferably in Oncology, Molecular Pathology, or Laboratory Medicine.
Fluent English (Oral and Written) skills required
Demonstrated track record of developing high performing teams and functional excellence
Demonstrated track record of managing and developing people
Expertise in processes development
Ability to work in a team environment
Ability to work within matrix organization
Strong interpersonal and influencing skills
Ability to work on multiple projects and under strict deadlines
Excellent oral/written/presentation communication skills
Ability to represent company externally to outside agencies or companies
Publications in top-tier journals