BMD Lead and Senior Principal Scientist
Novartis
Full time- 7+ years
- Not Disclosed
- Hyderabad, India
- Post Date: Apr 26, 2024
- End Date: Jun 26, 2024
- 7+ years
- Not Disclosed
- Hyderabad, India
- Post Date:Apr 26, 2024
- End Date: Jun 26, 2024
Skills:
- clinical research
- Operations
- Clinical Trial
- Inspection
Job Description:
Responsibilities
- Partner with BMD Biomarker Leads (BML) and biomarker subteam SMEs and contribute to project and study biomarker strategy, co-lead (with BML) the efficient transition of biomarker strategy to biomarker study operational plan for assigned studies
- Lead clinical biomarker operational study strategy and biomarker study plan implementation in TM clinical studies including providing input and reviews of clinical synopsis, study protocols, and other biomarker study operations documentation.
- Represent all BMD platforms and modalities in CTT including soluble, cellular, genetics, imaging and digital endpoints. Partner with BMD BML and SME and provide biomarker and operational expertise on all assigned clinical studies e.g. lead the BM setup, sample tracking/reconciliation, assay set up, data flow, vendor set up, biomarker sections of clinical study report and biomarker study closure
- Effectively engage and partner with BMD subteams and biomarker LF experts to ensure on time internal and external (vendor) biomarker deliverables. Update study and project information in relevant meeting, reports and IT systems
- Serve as a scientific monitor i.e. assay set up, assay transfer and implementation, and monitor biomarker assays at external service providers in one or more biomarker modalities (e.g. Immunoassay, LC-MS, Flow cytometry, tissues, genetics, digital endpoint and devices, etc.)
- Lead best practices, process and continuous improvement initiatives and innovations in sample, vendor, data flow and assay monitoring functions
- Contributes to talent and career development of Biomarker Science and Operations staff locally. In collaboration with the relevant BMD managers, contributes to the hiring/interview/onboarding and mentoring process for new hires in India
- Utilizes established networks and builds new network connections to bring new knowledge into the BMD department.
Qualification & Experience
- 7+ years in clinical trials and clinical biomarkers. Scientific and operational knowledge of clinical trials, study set up and operations, clinical sample analysis and managing external service provider (ESP) including central laboratories and/or specialized vendors
- Broad knowledge of clinical biomarkers including soluble, cellular, tissue, genetics, imaging and digital endpoints/devices. Track record of contributions to complex global early phase clinical trials and biomarker implementation
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Salary
Not Disclosed
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Role
Scientist
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Area of Practice
- Clinical Operations
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Experience
7+ years
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