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Scientific Lead

External
velsera logoVelsera · Pune, India
Full-timeHybrid2w ago
ClassificationClinical TrialsDocumentationLeadership
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Vision insurance

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Medicine moves too slow. At Velsera, we are changing that. Velsera was formed in 2023 through the shared vision of Seven Bridges and Pierian, with a mission to accelerate the discovery, development, and delivery of life-changing insights. Velsera provides software and professional services for: AI-powered multimodal data harmonization and analytics for drug discovery and development IVD development, validation, and regulatory approval Clinical NGS interpretation, reporting, and adoption With our headquarters in Boston, MA, we are growing and expanding our teams located in different countries! Designation: Scientific Lead Location: Pune, India (Hybrid) As a Scientific Lead, you will report to the Manager KB and your tasks will consist of application on strong molecular biology and cancer biology background to curate, interpret and represent data from variety of sources into logical rules that form the core of our clinical genomics knowledgebase. What will you do? Technical/Scientific Demonstrate clear understanding of therapies, drug mechanism of action, oncology disease biology, biomarker/mutation, the structure and the construction of KB rules, how it is applied to patient cases. Ability to analyze association of clinical recommendations of predictive, diagnostic, and prognostic recommendation for Oncology gene panels for NGS test. Ability to understand disease ontologies (example, WHO, SNOMED etc.) to construct custom disease ontology based on disease pathology and molecular cellular subtypes. Demonstrate understanding of somatic variant classification & classification hierarchy like AMP/ASCO/CAP classification, Germline variant classification like ACMG classification. Act as the accountable owner for curation of clinical content sources which includes clinical practice guidelines, approved drug labels (FDA, EMA), clinical trials and PubMed and take responsibility for overall QC/QA of the data curated by the team, ensuring delivery of high-quality data. - Contribute as reviewer of the curated content to review. - Review existing curation strategies and clinically significant data that is curated. - Understand usage of curated data is in the reporting platform and the impact on the patient care. SOPs &/or Work Instruction (WI) - Create/design workflow for new clinical content curation strategy or extrapolate existing curation strategies to a similar new biomarker/mutation scenario classifying variants for clinical NGS reporting. - Create/design SOPs &/or Work Instruction (WI) generation for the clinical oncology data curation process. - Identify potential risks of process, project or design, and report deviation from SOP or WI - Identify gaps or misalignment between written WI and workflow implementation and propose solutions. Demonstrate new ideas and ability to present and defend ideas in team or change control board meetings. Demonstrate problem solving mindset - provide clear solutions or take decisions to resolve blockers in day-to-day tasks and be able to support/justify them in scientifically acceptable way or by providing necessary evidence. Ability to ensure path for clinically conflicting data and observations within team Perform impact analysis for the deviation and propose a solution that is practical and accurate Initiate and drive discussions to ensure high quality KB adhering to the regulatory and customer requirements. Understand of content curation workflow thoroughly and come up with possible optimization and efficiency using upcoming technologies. Identify technology tooling requirements/enhancements to improve clinical content curation workflow. Act as a strong partner of the engineering team for software automation of scientific decision algorithms - ability to contribute towards process design and software design reviews. Provide mentorship to juniors and reviewers on clinical content strategies helping them to scale up. Demonstrate thought leadership: You should be seen as a reference and go-to person for niche expertise. Open to self-training and exploring new technologies. Communications Should be able to initiate discussions and communicate issues within team or across teams with clear background understanding to achieve outcome or conclusions. Initiate or engage in clear communication (slack, email, and verbal) regarding any blocker / issues with members of (other) teams, follow-up and conclude. Ability to develop documentation, power point presentations, flowcharts, diagrams etc. to communicate technical solutions. Operational Should have a strong sense of commitment, ownership & urgency and stay aligned with the SLAs. Establish strong tracking, quality control and communication (internal and external) methods of timely delivery. Decision making: Provide guidance in decision making to the team in case of blocker issues. Coach and train the team to take independent scientific decisions, tradeoffs and strong prioritization. Identify needs, gather supporti


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