As a Diagnostics (Dx) team member you will lead efforts to implement GSK diagnostic strategy including technical, clinical, regulatory, commercial, intellectual property and business development components by leading diagnostic projects and work streams according to agreed deliverables, timelines and budget. The aforementioned functional areas will partner with you to develop and commercialize Dx across therapeutic areas, with a main focus in Specialty programs such as liver diseases, Celiac's disease, and neurodegenerative diseases and may include some oncology companion diagnostic programs.
Dx team members execute precision medicine approaches in drug development through building collaboration within the GSK cross functional biomarker network and with external, diagnostic partners.Responsibilities:
Why You? Required Qualifications:
- Lead the end-to-end diagnostics strategy and diagnostics matrix team within early and late stage therapeutic programs to align all diagnostic development milestones with clinical development milestones and overall biomarker strategy. May also actively contribute to the overall program strategy and may be a member of Early Development Teams or Medicine Development Teams.
- Manage a team of 1-2 associates and support their programs and development.
- Accountable for all aspects of diagnostic development with external partners to develop, validate, implement, register and launch diagnostic tests required for therapeutic program regulatory approval.
- Establish and manage strategic partnerships to deliver diagnostic solutions to support the therapeutic program and the broader therapeutic pipeline.
- Oversee all technical aspects of development, assay validation and clinical implementation of the diagnostic assays across a program.
- 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.
- Leads matrix to ensure efficient implementation of all key deliverables for the diagnostic project.
- Lead the writing and/or the review of diagnostic portions of briefing documents, informed consents, clinical protocols, schedule of activities, clinical study reports, IDE, EU-IVDR, PMDA, NMPA, US-510(k)/PMA, and/or other regulatory submissions. Directly interact with regulatory authorities when required.
- Proactively identifies business issues/risks; proposes, recommends and implements strategies to manage implications and risks on business group level and/or clinical program timelines, budgets and goals. Actively makes decisions which balance risk/benefit with clear understanding of impact on project; takes action to mitigate risk where appropriate.
- Builds and maintains networks with asset 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 project status updates related to diagnostic program deliverables to senior management and to senior level matrix teams, both internally and externally.
- Where applicable, accountable for proposing, promoting and implementing key organizational process improvement initiatives in daily activities; may lead or drive such initiatives. Ensure learnings and best practices are shared across R&D.
- Participate in the evaluation of advanced technologies for IVD and clinical biomarker development.
- Coach and mentor direct reports and matrix team members and provide timely feedback and guidance to help them reach their goals.
- Advanced degree in Biological Sciences; either Ph.D or M.S., or a Bachelor's degree with appropriate pharmaceutical and IVD manufacturer experience.
- Understanding of Specialty area drug discovery & development especially late stage development and regulatory approval process and life cycle management.
- Experience with clinical trial design and execution (efficacy endpoints, biomarker testing), sample operations, data management and human biological specimen management)
- Experience with IVD development including design history file evaluation, risk assessments and all related analytical and clinical validation requirements.
- Proven track record of having supported diagnostic product development (e.g. pre-submission packets, SRD and IDE authoring and HDE/510k/PMA documentation) for class II and/or class III devices.
- Broad knowledge of technical platforms that include IHC, immunoassay, PCR, NGS and novel assay technologies (digital pathology, liquid biopsy, multiplex technologies).
- Experience performing due diligence and auditing vendors for CDx test placement.
- Understanding of GCP/GCLP, CLIA, CAP, ISO15189 laboratory requirements.
- Understanding of QSR regulations, GMP manufacturing, ISO13485, and FDA, EU and other ex-US medical device regulations.
- Detail oriented with strong organization skills.
- Exceptional written and verbal communication skills.
- Outstanding track record leading teams in a matrix environment.
- Able to manage multiple projects and work streams across TAs and R&D, including assessment of workload and resourcing requirements to deliver the team's objectives
- Able to represent GSK effectively in relationship building and due diligence and negotiations with external organizations, including academic institutions, vendors and CROs.
- Experience managing others.
- Statistical analysis plan development and diagnostic analysis required to support regulatory submissions
- Experience in supporting BIMO audits
- Experience in more than one therapeutic area. Understanding of oncology area drug discovery & development especially late stage development and regulatory approval process and life cycle management
- Experience in supporting Dx developments in ex-US countries.
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We're combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.
Our pipeline currently comprises of more than 60vaccines and medicines across four core therapeutic areas including infectious diseases, HIV, oncology and immunology as well at pursuing other science-led opportunities outside our core areas. Many have the potential to be first or best-in-class opportunities for patients and since 2017, we've delivered 13 major approvals and more than doubled the number of potential new vaccines and medicines in Phase 3 and registration to 23.
In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.
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