Manager, Sr. Manager, or Associate Director Companion Diagnostics (Oncology)
Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Jun 14 2021 Are you a professional in the companion diagnostics field looking to advance your career? If so, this Manager, Sr. Manager, Associate Director Companion Diagnostics role may be an ideal opportunity to explore! As a Companion Diagnostics (CDx) team member you will contribute to efforts to implement GSK diagnostics 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. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Help 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 biomarker strategy. Accountable for all aspects of diagnostic development with external partners to develop, validate and implement diagnostic tests required for specific clinical studies. Supports regulatory interactions by contributing to 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. 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. Where applicable, contributes to the implementation of strategies to manage risks on clinical study timelines, budgets and goals. Contributes to decisions which balance risk/benefit with clear understanding of impact on 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. Where applicable, accountable for implementing key organizational process improvement initiatives in daily activities. Participate in the evaluation of advanced technologies for IVD and clinical biomarker development. Why You Basic Qualifications: Advanced degree in Biological sciences; either Ph.D. with 3 years or more experience, or M.S. with minimum 5 years or more experience in pharmaceutical and/or IVD manufacturer experience. One or more years experience in IVD development including design history file evaluation, risk assessments and all related analytical and clinical validation requirements. One or more years experience using technical platforms that include IHC, immunoassay, PCR, NGS and novel assay technologies (digital pathology, liquid biopsy, multiplex technologies). Preferred Experience: Oncology therapeutic area expertise. One or more years of experience in drug development particularly clinical trial design and execution. One or more years experience in clinical biomarker investigation including biomarker operations and data management. 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. Understanding of IVD development including design history file evaluation, risk assessments and all related analytical and clinical validation requirements. Statistical analysis plan development, and diagnostic analysis required to support regulatory submissions. Knowledge of Ex-US testing and regulatory landscape. 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. Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *This is a job description to aide in the job posting, but does not include all job evaluation details. *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). 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