Mar 21, 2022

Job Description

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.
The Global Biomarker Associate Director (GBaD), supports the Disease Area Global Biomarker Diagnostic Leader (GBDL) by, contributing to the execution of the Oncology Precision Medicine Strategy for a given disease area GPT. The GBaD contributes to the implementation and execution of the disease area Precision Medicine strategy, with predominant focus on timely execution of biomarker activities to support decision making in the GPT and ensuring regulatory approval, of any CDx assays in collaboration with the CDx Regulatory team.

Your Responsibilities include, but are not limited:
• Contributes to the implementation & execution of the biomarker & diagnostic strategy
• Ensures timely execution of assay development for patient selection, stratification, pharmacodynamics, correlative studies and CDx development for clinical trials by working with internal stakeholders (global line functions) and external partners (clinical research organizations, • Academic Labs, clinical labs and diagnostic partners) for assigned program/studies with limited oversight
• Supports regulatory submissions by acting as subject matter expert within the team. Contributes scientific and technical sections of key regulatory documents including INDs, FDA briefing books, and submission documents (including NDAs, IDEs & PMAs). Coordinates data requirements with reference labs to support submission.
• Partners with Biomarker Trial Heads (BTHs) and other internal stakeholders to ensure all aspects of data collection and analysis are executed with quality, including correlative science analysis plan, data formatting and transfer specifications, eCRF page design, and monitoring plans for correlative study samples.
• Acts as core member of the International Clinical Team
• Functionally reports to the Global Biomarker & Diagnostic Head in GDD and operationally to the Global Biomarker & Diagnostic Director in Hematology.

Diversity & Inclusion / EEO

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.

Minimum Requirements

What you'll bring to the role:

• MD or Ph.D OR MD/PhD with minimum of 5 years of correlative science in Oncology, including biomarkers, of which a minimum of 1 years must be in Pharmaceutical industry. MD must have a minimum of 2 years’ experience in development & implementation of patient selection and other correlative strategies for clinical programs and/or oncology clinical trial experience.

• PhD in Molecular Biology, Oncology, Molecular Pathology, Lab Medicine, Life Sciences or

• MSc/MBA with equivalent experience in life sciences, Molecular Biology, Oncology, Molecular Pathology, Lab Medicine

• 3 years industry experience
• 3+ years multi/cross functional leadership experience within an Oncology business unit.
• Expert leadership skills proven in GPT, or in other organizational assignments. Expert skills to facilitate/optimize contribution of team members as individuals and members of cohesive team.
• Strong interpersonal and communication skills for bridging scientific and business participants, for negotiating timelines and for effective international collaboration.
• Diagnostic experience is an advantage
• Results driven

Why consider Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here 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.

Join our Novartis Network:

If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis
Network here: https://talentnetwork.novartis.com/network

Accessibility and reasonable accommodations:

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Global Drug Development
East Hanover, NJ
Research & Development
Full Time
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Global Biomarker Diagnostic Associate Director

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