US-NJ, Precision Medicine Leader-Cell and Gene Therapy -NJ or MA (Exec Dir) 213729BR-MZ
Precision Medicine Leader-Cell and Gene Therapy -NJ or MA (Exec Dir)
Global Drug Development
East Hanover, NJ
Research & Development
Accountable for the end-to-end design and delivery of precision medicine strategy supporting the C> GPT including biomarker discovery, development of assays and diagnostics to support patient selection/stratification/monitoring and safety 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 Program's strategic plan in close collabo-ration with the Global Program Head for drug program, other key OPM stakeholders (NIBR/TCO, Regulatory, 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 safety, pharmacodynamic and correlative studies are designed and implemented for clinical trials by working with internal stakeholders (GPH & GLFs) and external partners (CROs and Academic Labs) for assigned program(s).
3. For Dx assays, oversees the design of the target test profile (TTP), 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/TCO, Navigate, GPTs, RA, Commercial and others as needed. .
5. Ensures external labs are identified and validated to design and test assays (incl, Dx) for clinical trials.
6. 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
7. Supports regulatory submissions by acting as subject matter expert within the team. Con-tributes scientific and technical sections of key regulatory documents including INDs, FDA briefing books, IDEs, PMAs and other submission documents. Coordinates data require-ments with reference labs to support submission.
8. Frequent direct contact with external groups including medical experts as well as health authorities.
9. Partners with Biomarker Clinical Managers (BCM) and other internal stakeholders to ensure all aspects of data collection are executed with high quality.
10. Accountable to the Global Head of OPM and serves on Leadership team of function, key interface with managing internal and external stakeholder interactions on behalf of function, functional representative on key committees, may lead functional initiatives.
11. Act as core member of the GPT
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 minimum 10 years experience in Oncology Cell and Gene Therapy, Correlative Sciences, and/or Biomarker development of which a minimum of 5 years must be in Pharmaceutical industry.
MD or MD/PhD with a minimum of 5 years experience in development & implementation of patient selection and other correlative strategies for clinical programs and/or oncology clinical trial experience. Experience in cell and gene therapy is a plus. Residency in a general medical field with additional subspecialty training, preferably in Oncology, Molecular Pathology, or Lab Medicine
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 communication skills
Ability to represent company externally to outside agencies or companies
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