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Director - Service Excellence Portfolio Strategy

Company: Amazon Workforce Staffing
Location: Waltham
Posted on: September 17, 2020

Job Description:

Company: GlaxoSmithKline

Location: Waltham

Posted on: September 12, 2020

Job Description:

Director, Companion Diagnostics (Oncology) Waltham,Massachusetts; Collegeville, Pennsylvania

Medical and Clinical

Job description Site Name: USA - Pennsylvania - UpperProvidence, USA - Massachusetts - Waltham

Posted Date: Jul 27 2020

Job Description Are you energized by a highly-visible scientificleadership role that allows you to drive and shape scientificinnovation? If so, the Companion Diagnostics Lead (Director) rolecould be an exciting opportunity to explore. As a CompanionDiagnostics Lead, you will lead efforts to enhance innovationthrough the use of world-class information, tools, and techniquesto drive scientific excellence. This role will have responsibilityto deliver on the vision of equipping GSK to be a leader inprecision medicine through excellence in scientific discovery,clinical translation and CDx development driving value by treatingthe right patient with the right medicine.

I mplement GSK R&D wide CDx strategy encompassing technical,development, regulatory, commercial, IP and business developmentefforts by leading CDx projects and work streams according toagreed deliverables, timelines and budget. Leads thedevelopment and commercialization of companion diagnostics acrossall therapeutic areas with a focus on oncology.

Matrix team members act to embed a culture of change thatembraces precision medicine approaches in drug development throughbuilding collaboration and breaking down silos between groups thatwork in the biomarker continuum within GSK and externally.

This role will provide YOU the opportunity to lead keyactivities to progress YOUR career, these responsibilities includesome of the following…

Lead the companion diagnostics strategy within early and latestage therapeutic programs to align all companion diagnosticdevelopment milestones with clinical development milestones andoverall biomarker strategy

Be accountable for all aspects of CDx development with anexternal IVD partner to develop, validate, register andcommercialize CDx tests for prospective patient selection.

Oversee all technical aspects of development, assay validationand clinical implementation of the

selected assays

Authoring of companion diagnostic portions of informed consents,clinical protocols, schedule of activities, clinical study reports,IDE and PMA regulatory submissions

Collaborate with clinical operations and sample management toensure diagnostic testing and data generation is compliant with allregulatory requirements

Establish strategic partnerships to deliver diagnostic solutionsto support the pipeline

Exhibits timely management and delivery of projects/work streamswithin agreed budget

Must be able to manage multiple projects and work streams acrossTAs and R&D, including assessment of workload and resourcingrequirements to deliver the team’s objectives

Clearly and concisely report project progress and outcomes,coordinating with project management, finance and businessoperations

Ensure learnings and best practices are shared acrossR&D

Participate in the evaluation of advanced technologies for IVDand clinical biomarker development

Liaises with asset teams, regulatory, clinical and biomarkerleads, TA heads, and IVD partner joint project team members

Works with clinical, regulatory, operations, policy, BD andbusiness unit colleagues and key leadership within projectteams

Works with asset leads to ensure efficient implementation of allkey deliverables for the CDx

Provides frequent project status updates related to CDxdeliverables.

Why you? Basic Qualifications: We are looking for professionalswith these required skills to achieve our goals:

Ph.D. in the Biological Sciences and 5 years of pharmaceuticaland IVD manufacturer experience or M.S. with 10 years of Pharmaexperience.

Understanding of drug discovery & development especially latestage development and approval process and life cyclemanagement

Broad knowledge of technical platforms that include IHC,immunoassay, PCR, NGS and novel assay technologies (digitalpathology, liquid biopsy, multiplex technologies)

Proven track record of having supported CDx product development(pre-submission packets, SRD and IDE authoring and PMAdocumentation) for class II and class III devices

Understanding of drug discovery & development especially latestage development and approval process and life cyclemanagement

Understanding of IVD development including design history fileevaluation, risk assessments and all related analytical andclinical validation requirements

Experience performing due diligence and auditing vendors for CDxtest placement

Understanding of GCP/GCLP, CLIA, CAP, ISO15189 laboratoryrequirements

Understanding of QSR regulations, GMP manufacturing, ISO13485,and FDA and EU medical device regulations

Must be detail oriented with strong organization skills in orderto manage and meet deliverables

Understanding of clinical trial design and execution (efficacyendpoints, biomarker testing), sample operations, data managementand human biological specimen management)

Intermediate to advanced level experience with MS Officeproducts (Word, Excel, PowerPoint, SharePoint, Project) and remotemeeting tools such as WebEx and Skype

Demonstrate exceptional written and verbal communicationskills

Preferred Qualifications: If you have the followingcharacteristics, it would be a plus:

Experience with SAP development and diagnostic analysis requiredto support regulatory submissions

Experience in supporting BIMO audits

Experience in more than one therapeutic area preferable

Experience managing others is preferable

Experience in supporting CDx developments in ex-US countries,particularly China, Japan, Korea.

Why GSK? Our values and expectations are at the heart ofeverything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrityalong with Courage, Accountability, Development, and Teamwork. AsGSK focuses on our values and expectations and a culture ofinnovation, performance, and trust, the successful candidate willdemonstrate the following capabilities:

Agile and distributed decision-making – using evidence andapplying judgement to balance pace, rigour and risk.

Managing individual and team performance.

Committed to delivering high quality results, overcomingchallenges, focusing on what matters, execution.

Implementing change initiatives and leading change.

Sustaining energy and well-being, building resilience inteams.

Continuously looking for opportunities to learn, build skillsand 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, managingtrusted stakeholder relationships internally and externally.

Budgeting and forecasting, commercial and financial acumen.

*This is a job description to aide in the job posting, but doesnot include all job evaluation details.

If you require an accommodation or other assistance to apply fora job at GSK, please contact the GSK Service Centre at1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhereto Affirmative Action principles. This ensures that all qualifiedapplicants will receive equal consideration for employment withoutregard 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 orlocal protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/oremployment agencies in respect of the vacancies posted on thissite. All employment businesses/agencies are required to contactGSK's commercial and general procurement/human resources departmentto obtain prior written authorization before referring anycandidates to GSK. The obtaining of prior written authorization isa condition precedent to any agreement (verbal or written) betweenthe employment business/ agency and GSK. In the absence of suchwritten authorization being obtained any actions undertaken by theemployment business/agency shall be deemed to have been performedwithout the consent or contractual agreement of GSK. GSK shalltherefore not be liable for any fees arising from such actions orany fees arising from any referrals by employmentbusinesses/agencies in respect of the vacancies posted on thissite.

Please note that if you are a US Licensed HealthcareProfessional or Healthcare Professional as defined by the laws ofthe state issuing your license, GSK may be required to capture andreport expenses GSK incurs, on your behalf, in the event you areafforded an interview for employment. This capture of applicabletransfers of value is necessary to ensure GSK’s compliance to allfederal and state US Transparency requirements. For moreinformation, please visit GSK’s Transparency Reporting For theRecord site.

Keywords: GlaxoSmithKline, Waltham , Director, Companion Diagnostics (Oncology), Other , Waltham, Massachusetts

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Keywords: Amazon Workforce Staffing, Waltham , Director - Service Excellence Portfolio Strategy, Other , Waltham, Massachusetts

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