Senior Scientist – Novartis

The Senior Scientist Job at Novartis (Job ID: REQ-10078962) is an exceptional opportunity for experienced life sciences and clinical operations professionals looking to excel in Hyderabad, India. Novartis, a globally recognized leader in innovative medicines, is actively expanding its Laboratory Excellence and Operation (LEO) as well as its Biomarker Science and Operation (BSO) teams. This regular, full-time vacancy places you directly at the heart of translational medicine, helping orchestrate key global resources for clinical trial teams.

Responsibilities

In this operational capacity, you will drive excellence across global clinical studies centered around safety, PK samples, and advanced biomarkers. You will collaborate directly with cross-functional lines, Biomarker Leads (BMLs), and External Service Providers (ESPs) like specialized vendors and central labs.

1. Providing essential operational support during clinical study setup, sample tracking, reconciliation, and official study closure.

2. Supporting comprehensive reviews of clinical protocols, site operations manuals, informed consent forms, and central lab manuals.

3. Serving as the dedicated Biomedical Data (BMD) Study Coordinator and operational representative on selected clinical trials.

4. Setting up external central lab services independently while overseeing sample flows across varied modalities like Immunoassay, LC-MS, Flow Cytometry, and Genetics.

5. Monitoring, tracking, and escalating data quality, performance, or sample management challenges to clinical trial leadership.

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Requirements

1. Education: Master’s degree (M.Sc.) in Life Sciences, or an advanced degree in Clinical Bioanalysis, Biomarkers, Clinical Operations, or a related discipline.

2. Experience: Minimum of ~3+ years of relevant clinical operations experience inside the pharmaceutical or biotech space.

3. Clinical Knowledge: Demonstrated familiarity with clinical trial setup, data flows (such as DTS), and the hands-on management of central laboratories.

4. Regulatory Compliance: Deep understanding of global regulatory standards, including ICH/GCP and GLP tracking frameworks.

5. Core Skills: Stellar project management, proactive planning capabilities, and cross-functional matrix communication traits.