Lead Global Biomarker Trial Manager

322711BR
USA

Job Description

769 million lives were touched by Novartis medicines in 2020, 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!


As a Lead Global Biomarker Trial Manager you will be responsible for the operational implementation of the clinical study strategy related to biomarkers, including companion diagnostics, pre-selection, pharmacodynamic, predictive, and safety markers, in collaboration with line function (LF) representatives. Accountable for the timely operational execution of these assessments in protocols, in compliance with Novartis processes and regulatory requirements. Responsible for supervising a group of Biomarker Trial Managers and implementing best practices for execution of biomarker operations.
Your responsibilities include, but not limited to:

• Responsible for operational and functional management of Biomarker Trial Managers (BTMs). Establish annual objectives according to GDO Trial Management priorities. Conduct yearly performance review. Proactively manage performances issues. Support career development through quality development plans.

• In collaboration with Global Head Biomarker Operations, set standards for and continuously improve BTM performance, ensure sustainable global resourcing of BTMs across program, and may support management of internal sample repository.

• Actively support individual clinical trial teams (CTTs) and Precision Medicine teams as required for all technical and operational biomarker-related matters for assigned projects by liaising with internal stakeholders. Assist (Associate) Global Trial Director ((a)GTD) by forecasting the biomarker operational costs and reviewing invoices.

• Provide input on diagnostic and biomarker sections in clinical trial-related documents (such as protocols and consents) under the guidance of the LF representatives. Provide clinical operational support for companion diagnostic activities, as needed.

• Contribute to the training, implementation and compliance to standards (SOPs) and best practices for biomarker operations, including sharing lessons learned. May co-chair staff meeting.

• Lead or be a member of initiatives and working groups. Actively contribute to talent acquisition. Onboard and train new associates.

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

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.
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Global Drug Development
GDO GDD
USA
East Hanover, NJ
Research & Development
Full Time
Regular
No
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322711BR

Lead Global Biomarker Trial Manager

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