Senior Scientist, Laboratory Excellence Operations, Biomarker Dev

Novartis Pharmaceuticals Cambridge , MA 02138

Posted 2 months ago


  1. That's the number of concurrent clinical trials that Novartis is sponsoring at any given time.

Novartis Institutes for BioMedical Research (NIBR) is the global pharmaceutical research organization for Novartis committed to discovering innovative medicines that treat disease and improve human health. The Laboratory Excellence and Operation (LEO) team within NIBR's Biomarker Development group provides compliance, operational, sample planning/coordination, vendor management, scientific and data monitoring capabilities for biomarkers to other internal NIBR Novartis functions, such as Biomarker Development and Translational Medicine

As a Senior Scientist your responsibilities will include but not be limited to the following:

  • Independently place, implement and monitor "fit for purpose" complex biomarker assays at external service providers (ESP) in one or several biomarker modalities (e.g. Flow cytometry, Immunoassay, LC-MS, genetics etc .) in TM clinical studies (several biomarker modalities and global/complex studies for senior candidates). You may also serve as a SME in one of the biomarker modalities (for senior candidates).

  • Develop and provide operational reviews of global clinical study protocols, site operations manuals, informed consent forms, sample collection table, instruction manual, central lab protocol/manual, and eCRF and other biomarker sample logistics including study setup, sample tracking/reconciliation, assay set up and sample/data upload

  • Support data transfer and data flow in LIMS and DTS (e.g. study creation, data flow, data transfer, etc.) for managed biomarkers and studies. Update study and project information in relevant IT systems

  • Ensure quality and compliance of global external service provider (ESP) and their deliverables. Independently lead the development of new ESPs, including on qualification, on boarding, communication, and oversight.

  • Independently identify, escalate and resolve complex assay troubleshooting (independent troubleshooting/ resolutions for senior candidates), sample management, ESP, quality or performance issues and engage LF experts, clinical trial leaders and data management as needed.

  • Serve as Biomarker Expert (BME) in global TM clinical studies contribute to the biomarker strategy and the study design (independent BME contributions for senior candidates)

What you will bring to the role:

  • Advanced degree with 3 plus years in clinical operations and/or clinical bioanalysis, as well as training/experiences in global clinical study operation, vendor management and/or laboratory.

  • Strong scientific knowledge of global clinical operations, clinical sample analysis and management of external service provider (ESP).

  • Proven track record of independent contributions to clinical studies and clinical operations is required.

  • Laboratory knowledge and subject matter expertise in multiple technologies (e.g. Flow cytometry, MS, ELISA, etc.), platforms and clinical biomarkers

  • Experience working with ESP and monitoring biomarker work at external service providers (ESP) and data flows (LIMS, DTS, etc.).

  • Method development and troubleshooting experiences for complex bioanalytical and biomarker assays.

  • Knowledge of the drug development process and regulatory requirements e.g. GCP, GLP, etc

  • Fluent in English as working language.

Why consider Novartis?

Transformative medicines need transformative thinking. We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you are given opportunities to explore the power of digital and data. Where you are empowered to risk failure by taking smart risks, and where people who share your determination to tackle the world's toughest medical challenges surround you.

We are Novartis. Join us and help us reimagine medicine.

What you will bring to the role:

  • Advanced degree with 3 plus years in clinical operations and/or clinical bioanalysis, as well as training/experiences in global clinical study operation, vendor management and/or laboratory.

  • Strong scientific knowledge of global clinical operations, clinical sample analysis and management of external service provider (ESP).

  • Proven track record of independent contributions to clinical studies and clinical operations is required.

  • Laboratory knowledge and subject matter expertise in multiple technologies (e.g. Flow cytometry, MS, ELISA, etc.), platforms and clinical biomarkers

  • Experience working with ESP and monitoring biomarker work at external service providers (ESP) and data flows (LIMS, DTS, etc.).

  • Method development and troubleshooting experiences for complex bioanalytical and biomarker assays.

  • Knowledge of the drug development process and regulatory requirements e.g. GCP, GLP, etc

  • Fluent in English as working language.

Why consider Novartis?

Transformative medicines need transformative thinking. We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you are given opportunities to explore the power of digital and data. Where you are empowered to risk failure by taking smart risks, and where people who share your determination to tackle the world's toughest medical challenges surround you.

We are Novartis. Join us and help us reimagine medicine.


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Senior Scientist, Laboratory Excellence Operations, Biomarker Dev

Novartis Pharmaceuticals