US-MA, Precision Medicine Leader - GDD 226502BR-MZ
Precision Medicine Leader - GDD
Global Drug Development
Research & Development
Accountable for the end-to-end design and delivery of precision medicine strategy supporting GPTs including development of assays and companion diagnostics to support patient selection, stratification and monitoring ensuring regulatory approval, technical market access and optimized commercial value. Acts as disease subject matter expert within the GPT
1. Directly accountable for Precision Medicine strategy to support a Global Program Team (GPT). Drive and steer the implementation of the strategic plan in close collaboration with the Global Program Head for drug program, other key PM stakeholders (NIBR/BMD, Regu-latory, BD&L & commercial) and within the accepted timelines, budgets and resources at the required quality level
2. Leads a precision medicine sub-team to ensures patient selection/stratification/monitoring and correlative studies are designed and implemented for clinical trials by working with in-ternal stakeholders (GPH & GLFs) and external partners (CROs and Academic Labs) for assigned program(s).
3. For CDx assays, oversees the design of the Target Test Profile, the key claims portfolio and the platform strategy, and is accountable for the overall development strategy and plan, taking into consideration development, regulatory and commercial/consumer require-ments/needs that overall lead to a new diagnostic test. Ensures 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.
4. Coordinates activities and collaborates with all key PM stakeholders including NIBR/BMD/TM, Navigate or other external labs, GPTs, RA, Commercial and others as needed. .
5. Ensures the biomarker portions of key clinical documents including Clinical Development Plan, Clinical Study Protocols, Investigator Brochures, and Clinical Study Reports (CSRs) are completed in a timely manner
6. Supports regulatory submissions by acting as subject matter expert within the team.
7. Frequent direct contact with external groups including medical experts as well as health authorities.
8. Partners with Biomarker Clinical Managers (BCM) and other internal stakeholders to ensure all aspects of data collection are executed with high quality.
9. Accountable to the Global Head of Precision Medicine and serves on Leadership team of function, key interface with managing internal and external stakeholder interactions on be-half of function, functional representative on key committees, may lead functional initiatives.
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 with min. 10 years experience in On-cology Correlative Sciences, and/or Biomarker development of which a min of 5 years must be in Pharmaceutical industry. Fluent English (Oral and Written) skills required
- Ability to work in a team environment
- Ability to work within matrix organization
- Strong interpersonal and influencing skills
- Strong negotiation skills
- Ability to work on multiple projects and under strict deadlines
- Excellent oral/written/presentation communica-tion skills
- Ability to represent company externally to outside agencies or companies
- Results driven
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