The Precision Medicine Director (PMD), supports the Disease Area Precision Medicine Leader (PML) by, contributing to the development of the Oncology Precision Medicine (OPM) Strategy for a given disease area GPT. The PMD leads and oversees all aspects of implementation and execution of the disease area OPM strategy, with predominant focus on timely execution of biomarker activities to support decision making in the GPT and ensuring regulatory approval, of any CDx assays in collaboration with the CDx Regulatory team.
Contributes to the design of the disease area OPM strategy in support of a GPT. Responsible for the implementation & execution of the OPM strategy. 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 external partners (clinical research organizations, Academic Labs, clinical labs and diagnostic partners) for assigned program(s) with limited oversight. Contributes input to the PML and clinical team for assay development, molecular epidemiology, and other research-related activities with other internal stakeholders. Defines the vision, the target test profile, the key claims portfolio and the platform strategy, the overall CDx development strategy and plan based on regulatory and commercial/consumer requirements/needs that overall lead to a new diagnostic test. Drive and steer the implementation of the Program's strategic plan in close collaboration with the PML and other team members (including disease area project management, BDM, BCM, and others as needed) within the accepted timelines, budgets and resources at the required quality level. Leads companion diagnostic development as needed, and serves as a member of PML core team and Global Clinical Team (GCT) and other teams where implemented. In collaboration with research and early development functions, identify and validate external laboratories involved in assays for clinical trials and companion diagnostic development. Authors the biomarker/CDx portions of key clinical documents including Clinical Development Plan, Clinical Study Protocols, Investigator Brochures, and Clinical Study Reports. 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. Partners with Biomarker Clinical Managers (BCMs) and other internal stakeholders to ensure all aspects of data collection are executed with high quality, including correlative science analysis plan, data formatting and transfer specifications, eCRF page design, and monitoring plans for correlative study samples. Actively educates other team members through knowledge sharing.
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, MD OR MD/PhD preferred, with minimum of 7 years of correlative science and/or companion diagnostics experience in Oncology, including biomarkers, of which a minimum of 5 years must be in Pharma.
-Fluent English (written and oral),
-Doctoral in life sciences or chemistry, or MBA/MSc with equivalent experience in life sciences.
1. 5 years industry experience
2. 5+ years multi/cross functional leadership experience within an Oncology business unit.
3. Proven people leadership capabilities
4. Model natural leadership characteristics
5. Expert leadership skills demonstrated in GPT, in staff management role or in other organizational assignments. Expert skills to facilitate/optimize contribution of team members as individuals and members of cohesive team.
6. Strong interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective international collaboration.
7. Outstanding verbal and written communications.
8. Diagnostic experience is an advantage 9.Results driven. C&G experience, also some development experience (writing protocols, involvement in running studies etc). Diagnostics is an advantage
* If a direct employer requests that you go to their web site and complete your application there in order to be
considered, please do so. Applications for all positions are subject to each employer's specific requirements.