Associate Director of Diagnostics Precision Medicine
2 days ago
At GSK, we are committed to advancing the field of diagnostics precision medicine. We are seeking an experienced professional to lead our diagnostic projects and contribute to the implementation of our diagnostics strategy.
Key Responsibilities- Develop and lead end-to-end diagnostic strategy within early and late-stage therapeutic clinical studies to align all diagnostic development milestones with clinical development milestones and overall translational biomarker strategy.
- Accountable for all aspects of diagnostic development with external partners to develop, validate, and implement diagnostic tests required for specific clinical studies.
- Oversee all technical aspects of development, validation, and clinical implementation of the diagnostic assays within a clinical study.
- Collaborate with clinical operations and sample management to ensure diagnostic testing and data generation is compliant with all regulatory requirements.
- Exhibit timely management and delivery of projects/work streams within agreed budget.
- Works within, and may lead, matrix teams to ensure efficient implementation of all key deliverables for the diagnostic project.
- Supports regulatory interactions by contributing to the writing and the review of diagnostic portions of briefing documents, informed consents, clinical study protocols, clinical study reports, SRD, IDE, and PMA regulatory submissions.
- Where applicable, contributes to the implementation of strategies to manage risks on clinical study timelines, budgets, and goals. Contributes to decisions that balance risk/benefit with a clear understanding of the impact on the project.
- Builds and maintains networks with clinical study teams, regulatory, clinical, and biomarker leads, TA heads, project management, finance, business operations, and IVD partner joint project team members to ensure timely dissemination of information to appropriate levels to improve transparency.
- Provides frequent clinical study updates related to diagnostic project deliverables to management and to study-level matrix teams, both internally and externally.
- Advanced degree in Biological sciences.
- Experience in clinical trial design and execution (efficacy endpoints, biomarker testing), sample operations, data management, and human biological specimen management.
- Experience in clinical/translational biomarker investigation, including biomarker operations and data management.
- Experience with IVD development, including design history file evaluation, risk assessments, and all related analytical and clinical validation requirements.
- Experience in technical platforms that include IHC, immunoassay, PCR, NGS, and novel assay technologies (digital pathology, liquid biopsy, multiplex technologies).
- Experience with MS Office products (Word, Excel, PowerPoint, SharePoint, Project) and remote meeting tools such as WebEx and Microsoft Teams.
- Therapeutic area expertise in multiple specialty areas.
- Performing due diligence and auditing vendors for clinical test execution.
- Familiarity with clinical laboratory and medical device requirements, including GCP/GCLP, CLIA, CAP, ISO15189, QSR regulations, GMP manufacturing, ISO13485, including FDA/US and EMA/EU.
- Diagnostic product development (pre-submission packets, SRD, and IDE authoring and HDE/510k/PMA documentation) for class II and/or class III devices, including companion/complimentary diagnostics and surrogate efficacy biomarkers.
- Knowledge of US and Ex-US testing regulatory landscape, including evolving IVDR requirements in the EU and HGR regulations in China.
- Able to manage multiple projects, including assessment of workload and resourcing requirements to deliver the team's objectives.
- Detail-oriented with strong organization skills.
- Exceptional written and verbal communication skills.
- Good track record working within a matrix team environment.
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Stevenage, Hertfordshire, United Kingdom VONQ Full timeJob DescriptionJob Title: Associate Director- Diagnostics Precision MedicineLocation: USA - Massachusetts - Waltham, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper ProvidenceJob Type: Full-timeAbout Us: We are a global biopharma company dedicated to uniting science, technology, and talent to get ahead of disease together.Job SummaryWe are seeking...
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Stevenage, Hertfordshire, United Kingdom VONQ Full timeJob DescriptionJob Title: Associate Director- Diagnostics Precision MedicineLocation: USA - Massachusetts - Waltham, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper ProvidenceJob Type: Full-timeAbout Us: We are a global biopharma company dedicated to uniting science, technology, and talent to get ahead of disease together.Job SummaryWe are seeking...
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Stevenage, Hertfordshire, United Kingdom VONQ Full timeJob DescriptionWe are seeking a highly skilled and experienced Associate Director to lead our Diagnostics Precision Medicine team. As a key member of our organization, you will be responsible for developing and implementing diagnostic strategies to advance our precision medicine initiatives.Key Responsibilities:Develop and lead end-to-end diagnostic...
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Stevenage, Hertfordshire, United Kingdom VONQ Full timeJob DescriptionWe are seeking a highly skilled and experienced Associate Director to lead our Diagnostics Precision Medicine team. As a key member of our organization, you will be responsible for developing and implementing diagnostic strategies to advance our precision medicine initiatives.Key Responsibilities:Develop and lead end-to-end diagnostic...
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Stevenage, Hertfordshire, United Kingdom VONQ Full timeJob DescriptionWe are seeking a highly skilled and experienced Associate Director to lead our Diagnostics Precision Medicine team. As a key member of our organization, you will be responsible for developing and implementing diagnostic strategies to advance our precision medicine initiatives.Key Responsibilities:Develop and lead end-to-end diagnostic...
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Stevenage, Hertfordshire, United Kingdom VONQ Full timeJob DescriptionWe are seeking a highly skilled and experienced Associate Director to lead our Diagnostics Precision Medicine team. As a key member of our organization, you will be responsible for developing and implementing diagnostic strategies to advance our precision medicine initiatives.Key Responsibilities:Develop and lead end-to-end diagnostic...
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