Global Biomarker Diagnostic Director (Hematology & CART)
- East Hanover, NJ
2005! That's the year that Novartis began exploring Precision Medicine to extend and improve the lives of patients, by enabling the regulatory approval and commercial sale of transformative therapies.
Precision Medicine (PM) is an approach for prevention, diagnosis, treatment, and monitoring of disease that considers individual variability in biology, environment, and lifestyle for each person (source: NIH). Patient biomarker data and diagnostic assays drive healthcare decision-making by helping physicians identify patients for the right treatment and monitor their disease. Beyond biomarkers and companion diagnostics, precision medicine supports the Novartis pipeline by facilitating clinical trial design and execution, accelerating drug development, and informing early pipeline choices. By using advances in biology, technology, and data & digital solutions, Novartis Precision Medicine continues to innovate in our quest to disrupt treatment paradigms and reimagine medicine.
As Global Biomarker Diagnostic Director, you will lead and be responsible for all aspects of the execution of the program's precision medicine strategy with predominant focus on execution of activities to support decision making and regulatory approval of any Companion Diagnostic (CDx) assays.
Your responsibilities include, but are not limited to:
• Develop the program Precision Medicine strategy aligned to the disease area in support of a global program team (GPT). Also responsible for leading the precision medicine program team for assay development, molecular epidemiology, and other research-related activities with other internal stakeholders
• Serves as a core member of the Global program team (GPT) and core member of the Global Clinical Team (GCT) and other teams where implemented
• Establish and maintain partnership with internal stakeholders (global line functions) and external partners (clinical research organizations, Academic Labs, clinical labs and diagnostic partners) for assigned program(s) to drive the implementation of the program's strategic plan.
• Collaborate with early commercial, quality assurance functions, identify ,validate, partner with external laboratories involved in assays for clinical trials and companion diagnostic development
• Responsible for data generation in studies ensuring consistency with global development strategy within a specific disease area
• Avoids strategic and operational crises by proactively identifying and handling 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)
• Act as biomarker & diagnostic expert, providing strategic guidance and scientific support for cross-functional goals (Medical Affairs, Commercial and Market Access leads)
• Provide scientific expertise and support to CPO and regional colleagues for product launches and post-launch management related to diagnostic testing as required
EEO Statement 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 other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
What you'll bring to the role:
• PhD or MD or MD/PhD preferred, with 5 years' experience in correlative science and/or companion diagnostics, experience in Oncology, including biomarkers
• Minimum of 3 years industry, or comparable drug development experience within a biotech or pharma environment
• Proven contribution to project goals within a program team, or in other organizational assignments
• Strong interpersonal and communication skills for bridging scientific and business participants and communicating strategy across internal team
• Proven people leadership capabilities
• Strong interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective international collaboration.
• Knowledge of oncology companion diagnostic development is an advantage
• Knowledge in hematological malignancies is an advantage
• Diagnostic or pharmaceutical focused clinical experience is an advantage
Why consider Novartis?
799 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
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