Director Companion Diagnostics Oncology
Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: May 28 2021 As a Companion Diagnostics (CDx) 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 CDx across therapeutic areas, with a focus in oncology. CDx 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 include The CDx director is responsible for the following: 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. 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 the review of diagnostic portions of briefing documents, informed consents, clinical protocols, schedule of activities, clinical study reports, IDE and PMA 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. Required Qualifications Advanced degree in Biological Sciences; either Ph.D. with 5 years of experience with diagnostic development in a pharmaceutical setting or M.S. with 10 years of combined pharmaceutical and IVD manufacturer experience. Understanding of oncology 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. Experience having supported diagnostic product development (pre-submission packets, SRD and IDE authoring and HDE/510k/PMA documentation) for class II and/or class III devices. Working knowledge with technical platforms that include IHC, immunoassay, PCR, NGS (DNA and RNA based), and novel assay technologies (digital pathology, liquid biopsy, multiplex technologies). Experience performing due diligence and auditing vendors for CDx test placement. Knowledge of GCP/GCLP, CLIA, CAP, ISO15189 laboratory requirements. Experience with QSR regulations, GMP manufacturing, ISO13485, and FDA, EU and other ex-US medical device regulations. Experience managing others. Preferred Experience Statistical analysis plan development and diagnostic analysis required to support regulatory submissions Experience in supporting BIMO audits Experience in more than one therapeutic area Experience in supporting CDx developments in ex-US countries. Exceptional written and verbal communication skills. Outstanding track record leading teams in a matrix environment. Able to represent GSK effectively in relationship building and due diligence and negotiations with external organizations, including academic institutions, vendors and CROs. 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. Company At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. 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