Principal Scientist, BMD Study Coordinator and BMD Study Expert (BSC/BSE) Biomarkers Development (BMD)

Novartis; Hyderabad; On-site; INR 3,000,000 - 4,200,000; Full time

Job summary

Novartis in Hyderabad seeks a Principal Scientist for BMD Study Coordination and Expert roles in Biomarkers Development. You will lead end-to-end operations for biomarker and PK samples, coordinate with central labs, ESPs and cross-functional TM teams to ensure timely, high-quality data for biomarker-driven decisions.

The role requires strong clinical operations experience, knowledge of immunoassays/bioanalysis, and global project management within a matrix organization.

Qualifications

• Education: BS in life science; 7+ years in clinical operations, bioanalysis or biomarkers; advanced degree with 3 years in clinical ops/bioanalysis/biomarkers.

Responsibilities

• Independently provide end-to-end operational support to clinical studies focusing on biomarkers and PK samples, study setup, sample tracking, and study closure.
• Serve as BMD Study Expert/BSE and clinical team representative for selected studies; partner with clinical teams and functions.
• Set up central lab services (specifications, sites, samples, assays) and monitor biomarker/PK sample flow across modalities (Immunoassay, LC-MS, Flow cytometry, genetics).
• Coordinate with BMD SME to set up assays at ESPs, ensuring data transfer and data flows in LIMS and DTS; update study information in reports and IT systems.
• Identify and resolve assay and sample management issues with ESP/vendors; engage LF experts as needed.
• Lead best practices and continuous improvement initiatives in sample, vendor, data and assay monitoring.
• Collaborate across TM functions; drive process improvements in LEO.

Skills

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

Education

BS in life science / advanced degree

Tools

DTS data flows

LIMS

Job description

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.

Job Description

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, escalat 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.

Job Dimensions

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.

Requirements

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.

Experience / Professional

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 Job holder :

Date and signature supervisor :

Skills Desired

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