US-NJ, Precision Medicine Assoc. Director - GDD 226423BR-MZ
Precision Medicine Assoc. Director - GDD
Global Drug Development
East Hanover, NJ
Research & Development
The Precision medicine associate director (PMaD) is responsible for defining and driving the PM strategy for a specific program, or indication, within a global drug de-velopment franchise(s).
Ensures timely execution of assay development for patient selection, stratification, , contributes to the correlative studies and drives companion diagnostic (CDx) and complementary diagnostic (Co-Dx) development for clinical trials by working with internal stakeholders (global line functions, NIBR/TM/BMD) and external partners (clinical research organizations, Academic Labs, clinical labs and diagnostic partners) for assigned program(s) 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/Co-Dx development strategy and plan Contributes to companion and/or complementary diagnostic development as needed, and serves as a member of theteams as required. Manages the identification and validation of external laboratories involved in Clinical Trial Assays (CTAs) for clinical trials and particularly companion/complementary diagnostic development. Authors the biomarker/Dx 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. Partners with Biomarker sample 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. Contributes to the development and implementation of processes supporting patient pre-selection and stratification, pharmacodynamic monitoring, correlative studies & requirements for diagnostic development 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, 3 years industry, or equivalent drug development experience English
2. 3+ years multi/cross functional leadership experience with-in pharmaceutical or academic environment.
3. Model natural leadership characteristics
4. Expert leadership skills demonstrated in a Global Team, or in other organizational assignments. Expert skills to facili-tate/optimize 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 time-lines and for effective international collaboration.
6. Outstanding verbal and written communications.
7. Diagnostic experience is an advantage
8. Results driven
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