Novartis Pharmaceuticals Diagnostic Sciences Director (DxSD) in Cambridge, Massachusetts
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.
Role can be filled in either Cambridge, MA or East Hanover, NJ
The Diagnostic Sciences Director (DXSD) is a core member of Global Biomarker and Diagnostics Teams (GBDTs) overseeing therapeutic development requiring diagnostic testing systems for regulatory biomarkers (i.e. those used for patient selection / stratification / enrichment / monitoring). Together with cross-divisional GBDTs, the DXSD is accountable for developing the diagnostic strategy for these biomarkers and, as part of the PM-GDD function, managing teams and budgets allocated to their disease area(s) of focus. Diagnostic co-development efforts led by the DXSD ultimately support effective therapeutic launches falling under the remit of the Global Program Teams (GPTs) developing these precision medicines.
Your responsibilities include, but are not limited to:
• As a core-member of one or more, cross-divisional, GBDTs, co-creates the biomarker and diagnostic strategy for therapeutics requiring diagnostic testing solutions for global clinical trials and effective worldwide launch.
• Responsible for defined elements of BD&L led search and evaluation / technical due diligence / SWAT analyses in relation to diagnostic technology providers.
• Accountable for the implementation and execution diagnostic strategies (from co-developing the DxTPP through diagnostic registration) across the product lifecycle for multiple therapeutics
• Accountable to GPTs (through GBDTs) for handling clinical program milestones and budgets dependent on regulatory biomarkers and diagnostic testing systems (e.g. authors the biomarker/CDx portions of key clinical documents, handles technical and financial risks associated with CDx co-development etc.)
• Accountable for ensuring clinical trial assays implemented in GDD-sponsored trials are fit-for-purpose in accordance with Novartis SOPs.
Accountable for handling scientists who execute defined elements of the biomarker and diagnostic strategy
• As a key member of Joint Program Teams (JPTs) established with strategic diagnostic partners, responsibilities include ensuring regulatory dossiers for global health authority submissions are technically sound. Supports regulatory submissions by acting as subject matter expert within the team. Supports registration and launch of diagnostic testing systems in a manner that optimizes patient access to Novartis medicines requiring these systems (e.g. to establish eligibility for the therapeutic, monitor response etc.)
Diagnostic Sciences Director (DxSD)
What you'll bring to the role:
• Ph.D preferred in a related subject area (e.g. Molecular Biology, Pharmacology etc.) with minimum of 5 years of drug / diagnostic development experience or MSc/MBA with equivalent experience.
• 5+ years industry experience
• Key contributor to cross-functional teams
• An enterprise-leader with scientific integrity and business acumen
• Outstanding verbal and written communications
• Diagnostic development experience is an advantage
Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. 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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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.