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Associate Director - Companion Diagnostics, Oncology EMU

Waltham, Massachusetts; Collegeville, Pennsylvania
Closing date
Dec 4, 2021

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Site Name: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Oct 19 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). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.
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