The Precision Medicine Associate Director (PMD), supports the Disease Area Precision Medicine Leader (PML) by, contributing to the execution of the Oncology Precision Medicine (OPM) Strategy for a given disease area GPT. The PMaD contributes to the 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.
1. Functionally and operationally reports to the VP, Global Head of Translational Precision Oncology Center of Excellence (TPO-CoE) and .
2. Contributes to the implementation & execution of the OPM strategy
3. 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
4. Contributes input to the PML and clinical team for assay development, molecular epidemiology, and other research-related activities with other internal stakeholders. Contributes to the target test profile, and the overall CDx development strategy and plan
5. Contributes to companion diagnostic development as needed, and serves as a member of PML core team and International Clinical Team (ICT) and other teams where implemented.
6. In collaboration with TCO/NIBR, identify and validate external laboratories involved in CTAs for clinical trials and companion diagnostic development.
7. Authors the biomarker/CDx portions of key clinical documents including Clinical Development Plan, Clinical Study Protocols, Investigator Brochures, and Clinical Study Reports (CSRs)
8. 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.
9. Partners with Biomarker Trial Heads (BTHs) 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.
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
11. Acts as core member of the International Clinical Team
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)
13. Compliance to applicable US and international Medical Device regulations and standards including, but not limited to, 21 CFR 820, ISO 13485, 93/42/EEC, 98/79 EC, and the requirements of the Novartis CDx Quality Management System.
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 in life sciences or chemistry, or MBA/MSc with equivalent experience in life sciences.
Fluent English (written and oral),
1. 3 years industry experience
2. 3+ years multi/cross functional leadership experience within an Oncology business unit.
3. Model natural leadership characteristics
4. Expert leadership skills demonstrated in GPT, or in other organisational assignments. Expert skills to facilitate/optimise 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. Diagnostic experience is an advantage
8. Results driven