Global Program Safety Lead (CAR T-cell Therapy)

Sep 02, 2021

Job Description

769 million. That’s how many lives our products touched in 2020. 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?

Novartis has a mission to reimagine medicine by bringing curative cell & gene therapies to patients worldwide, and was one of the first pharmaceutical companies to pioneer CAR-T research and initiate global CAR-T trials. Novartis has a strong CAR-T pipeline and ongoing investment in manufacturing and supply chain process improvements. With active research underway to broaden the impact of cell and gene therapy in oncology, Novartis is going deeper in hematological malignancies, reaching patients with other cancer types and evaluating next-generation CAR-T cell therapies that focus on new targets and utilize new technologies.

**This position can be based remotely anywhere in the U.S. (there may be some exceptions based on legal entity registration). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.**

Your responsibilities include, but are not limited to:
• Provide expert safety input to the clinical development program for assigned projects/products and be an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT)

• Responsible for safety issue management from formation of Global Program Team (GPT) through Life Cycle Management.

• Develops and is responsible for key internal Novartis safety documents: reviews these documents regularly and updates as required

• Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, post-marketing data, and other sources

• Responsible for documentation/tracking/record keeping of the assigned compounds medical safety activities

• Responsible for initial development and ongoing maintenance of safety information in Core Data Sheet (core global labeling), including addressing safety issues effectively in all project/product labeling indications

• Responsible for responses to inquiries from regulatory authorities or health care professionals on safety issues

• Leads the preparation of the safety strategy for health authority responses and strategy, in collaboration with other project team members

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:

• Medical Degree (MD) or equivalent required

• 3 years clinical experience postdoctoral

• 5 years drug development experience in a major pharmaceutical company (of which 2 years should be in a global position); including 2 years in safety at an operational or medical position

• Experience in scientific analysis, clinical safety assessments and regulatory discussions on safety and risk management

• Prior experience of leading cross-functional, multi-cultural teams

• Experience in leading cross-functional, multi-cultural teams and of (safety or others) issue management

Why consider Novartis?

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.

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:
Global Drug Development
East Hanover, NJ
Research & Development
Full Time
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Global Program Safety Lead (CAR T-cell Therapy)

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