Principal Scientist, BMD Study Coordinator and BMD Study Expert (BSC/BSE) Biomarkers Development (BMD)
DiscoveredNovartis
Hyderabad (Office)Full timePosted 6 days ago (Aug 7, 2026)
Job Description Summary
Laboratory Excellence and Operation (LEO) and Biomarker Science and Operation (BSO) team in India are the key global resources for Line functions (LF) and Translational Medicine (TM) Clinical Trial Teams for biomarkers including biomarker outsourcing, scientific biomarker monitoring, vendor management, biomarker logistics, clinical site communication and sample coordination. LEO/BSO are working in close collaboration with clinical teams, LF technology experts, Biomarker Leads (BMLs) as well as external service providers (ESP) including central labs and clinical sites.
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Job Description@@/HD@@
BR
ROLE PROFILE
General
Job Title
Principal Scientist, BMD Study Coordinator and BMD Study Expert (BSC/BSE) Biomarkers Development (BMD)
Job Grade
Level 4
Department
BMD/ LEO
Reports to
Jitesh Narayan Iyer
Job Purpose
(State in one sentence the overall objective of the job)
Laboratory Excellence and Operation (LEO) and Biomarker Science and Operation (BSO) team in India are the key global resources for Line functions (LF) and Translational Medicine (TM) Clinical Trial Teams for biomarkers including biomarker outsourcing, scientific biomarker monitoring, vendor management, biomarker logistics, clinical site communication and sample coordination. LEO/BSO are working in close collaboration with clinical teams, LF technology experts, Biomarker Leads (BMLs) as well as external service providers (ESP) including central labs and clinical sites.
Major Accountabilities
• Independently provide end to end operational support to clinical studies focusing on biomarkers and PK samples, clinical study setup, sample tracking/reconciliation, assay and vendor set up, sample/data upload and study closure. Specific steps include independent review of clinical study protocols, site operations manuals, informed consent forms, sample collection tables, instruction manuals, central lab protocol/manual, eCRF and other biomarker sample operation logistics and coordination including
• Serve as a BMD Study Expert BSE and clinical team representative from BMD on selected clinical studies and/or at a project level. Partner with clinical teams and functions
• Independently set up central lab and central lab services (specifications, clinical sites, samples, assays), implements and monitors biomarker/PK sample flow across BM modalities (e.g. Immunoassay, LC-MS, Flow cytometry, genetics etc.) and PK assays
• Partners with BMD SME to set up, implement biomarker assays at specialized external service providers (ESP) including data transfer and data flows 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 reports and IT systems
• Identify, escalate and resolve assay and sample management issues, ESP, quality or performance issues and engage LF experts/SME, clinical trial leaders and data management as needed.
• Lead best practices, process and continuous improvement initiatives and innovations in sample, vendor, data and assay monitoring function
• Collaborate with across TM functions, lead site, central lab and vendors processes, drives continuous improvement initiatives and innovations in LEO
Key Performance Indicators
• Ensure sample and biomarker data deliverables according to timelines and quality, ensuring adherence to international and local regulations.
• Effective risk management and troubleshooting of samples and biomarker assays
• Feedback of external and internal customers.
• Adherence to Novartis Values and Behaviors.
Number of associates
No direct reports. Matrix management and contribution to multi-disciplinary teams. Manage the interaction with external CRO partners.
Financial responsibility
Responsible for financial/resource decisions within scope of designed authority.
Impact on the organisation
Internal impact: Responsible for the availability of high-quality biomarker data according to agreed timelines and quality to enable no delays in decision making and drug registration.
External impact: Novartis perceived as a reliable business partner.
Education (minimum/desirable): Minimum
BS in life science with 7+ years of clinical operations experiences and/or clinical bioanalysis and/or clinical biomarkers. Advance degree with 3 years in clinical operations and/or clinical bioanalysis and/or clinical biomarkers
Languages
Fluent in English as working language.
Requirement
• Operational knowledge of clinical trials: clinical study set up, clinical sample management, clinical data flows (e.g. DTS) clinical sample analysis and managing external service provider (ESP) including central laboratories and/or specialized vendors
• Laboratory background and knowledge of immunoassays and/or bioanalysis and data flows are desired. Data management background and experience is a plus
• Knowledge of the drug development process, clinical biomarkers, clinical data management and working with translation clinical research.
• Experience working in a global organization and matrix environment (multiple roles/connections and stakeholders) is a plus.
• Strong global project management, proactive planning in clinical studies, problem solving, influencing, and communication skills.
• Knowledge of regulatory requirements e.g. ICH/GCP, GLP, etc.
Date and signature supervisor
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Skills Desired@@/HD@@
Analytical Thinking, Chemical Biology, Chemistry, Clinical Trials, Collaboration, Curious Mindset, Data Analysis, Detail-Oriented, Drug Development, Ethics, Gene Therapy, Immunology, Inventory Management, Machine Learning (ML), Medical Research, Molecular Biology, Python (Programming Language), Science
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