Director, Companion Diagnostics (Oncology)

Company: GSK
Location: Collegeville
Posted on: August 3, 2020

Job Description:

Site Name: USA - Pennsylvania - Upper Providence, USA - Massachusetts - WalthamPosted Date: Jul 24 2020Job DescriptionAre you energized by a highly-visible scientific leadership role that allows you to drive and shape scientific innovation? If so, the Companion Diagnostics Lead (Director) role could be an exciting opportunity to explore.As a Companion Diagnostics Lead, you will lead efforts to enhance innovation through the use of world-class information, tools, and techniques to drive scientific excellence. This role will have responsibility to deliver on the vision of equipping GSK to be a leader in precision medicine through excellence in scientific discovery, clinical translation and CDx development driving value by treating the right patient with the right medicine.Implement GSK R&D wide CDx strategy encompassing technical, development, regulatory, commercial, IP and business development efforts by leading CDx projects and work streams according to agreed deliverables, timelines and budget. Leads the development and commercialization of companion diagnostics across all therapeutic areas with a focus on oncology.Matrix team members act to embed a culture of change that embraces precision medicine approaches in drug development through building collaboration and breaking down silos between groups that work in the biomarker continuum within GSK and externally.This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the followingLead the companion diagnostics strategy within early and late stage therapeutic programs to align all companion diagnostic development milestones with clinical development milestones and overall biomarker strategy Be accountable for all aspects of CDx development with an external IVD partner to develop, validate, register and commercialize CDx tests for prospective patient selection.Oversee all technical aspects of development, assay validation and clinical implementation of theselected assaysAuthoring of companion diagnostic portions of informed consents, clinical protocols, schedule of activities, clinical study reports, IDE and PMA regulatory submissionsCollaborate with clinical operations and sample management to ensure diagnostic testing and data generation is compliant with all regulatory requirementsEstablish strategic partnerships to deliver diagnostic solutions to support the pipelineExhibits timely management and delivery of projects/work streams within agreed budget Must be able to manage multiple projects and work streams across TAs and R&D, including assessment of workload and resourcing requirements to deliver the teams objectivesClearly and concisely report project progress and outcomes, coordinating with project management, finance and business operationsEnsure learnings and best practices are shared across R&DParticipate in the evaluation of advanced technologies for IVD and clinical biomarker developmentLiaises with asset teams, regulatory, clinical and biomarker leads, TA heads, and IVD partner joint project team membersWorks with clinical, regulatory, operations, policy, BD and business unit colleagues and key leadership within project teams Works with asset leads to ensure efficient implementation of all key deliverables for the CDxProvides frequent project status updates related to CDx deliverables.Why you?Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:Ph.D. in the Biological Sciences and 5 years of pharmaceutical and IVD manufacturer experience or M.S. with 10 years of Pharma experience. Understanding of drug discovery & development especially late stage development and approval process and life cycle managementBroad knowledge of technical platforms that include IHC, immunoassay, PCR, NGS and novel assay technologies (digital pathology, liquid biopsy, multiplex technologies)Proven track record of having supported CDx product development (pre-submission packets, SRD and IDE authoring and PMA documentation) for class II and class III devicesUnderstanding of drug discovery & development especially late stage development and approval process and life cycle managementUnderstanding of IVD development including design history file evaluation, risk assessments and all related analytical and clinical validation requirementsExperience performing due diligence and auditing vendors for CDx test placementUnderstanding of GCP/GCLP, CLIA, CAP, ISO15189 laboratory requirementsUnderstanding of QSR regulations, GMP manufacturing, ISO13485, and FDA and EU medical device regulationsMust be detail oriented with strong organization skills in order to manage and meet deliverablesUnderstanding of clinical trial design and execution (efficacy endpoints, biomarker testing), sample operations, data management and human biological specimen management)Intermediate to advanced level experience with MS Office products (Word, Excel, PowerPoint, SharePoint, Project) and remote meeting tools such as WebEx and SkypeDemonstrate exceptional written and verbal communication skillsPreferred Qualifications:If you have the following characteristics, it would be a plus:Experience with SAP development and diagnostic analysis required to support regulatory submissionsExperience in supporting BIMO auditsExperience in more than one therapeutic area preferableExperience managing others is preferableExperience in supporting CDx developments in ex-US countries, particularly China, Japan, Korea.Why GSK?Our values and expectationsare 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.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.Important notice to Employment businesses/ AgenciesGSK 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 GSKs compliance to all federal and state US Transparency requirements. For more information, please visit GSKs Transparency Reporting For the Record site.

Keywords: GSK, Philadelphia , Director, Companion Diagnostics (Oncology), Executive , Collegeville, Pennsylvania