Manager Companion Diagnostics - GlaxoSmithKline plc (Latrobe)

Employment Type

: Full-Time


: Scientific Research

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Are you energized by an opportunity to better leverage your scientific and project leadership expertise? If so, this Companion Diagnostics Manager role could be an exciting opportunity to explore.

As a Companion Diagnostics Manager you will 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 following

  • Lead 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 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 to ensure diagnostic testing and data generation is compliant with all regulatory requirements
  • Establish strategic partnerships to deliver diagnostic solutions to support the pipeline
  • Exhibits 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 objectives
  • Clearly and concisely report project progress and outcomes, coordinating with project management, finance and business operations
  • Ensure learnings and best practices are shared across R&D
  • Participate in the evaluation of advanced technologies for IVD and clinical biomarker development
  • Liaises with asset teams, regulatory, clinical and biomarker leads, TA heads, and IVD partner joint project team members
  • Works 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 CDx
  • Provides 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 3-5 years of pharmaceutical and IVD manufacturer experience or M.S. with 15 years of other relevant Pharma experience.
  • Understanding of drug discovery & development especially late stage development and approval process and life cycle management
  • Broad knowledge of technical platforms that include IHC, immunoassay, PCR, NGS and novel assay technologies (digital pathology, liquid biopsy, multiplex technologies)
  • Understanding of drug discovery & development especially late stage development and approval process and life cycle management
  • Understanding of IVD development including design history file evaluation, risk assessments and all related analytical and clinical validation requirements
  • Experience performing due diligence and auditing vendors for test placement
  • Understanding of GCP/GCLP, CLIA, CAP, ISO15189 laboratory requirements
  • Understanding of QSR regulations, GMP manufacturing, ISO13485, and FDA and EU medical device regulations
  • Must be detail oriented with strong organization skills in order to manage and meet deliverables
  • Understanding 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 Skype
  • Demonstrate exceptional written and verbal communication skills
  • Preferred Qualifications:

    If you have the following characteristics, it would be a plus:

  • Experience with SAP development and diagnostic analysis required to support regulatory submissions
  • Experience in oncology therapeutic area preferable
  • Experience in supporting CDx developments and/or biomarker testing in ex-US countries
  • Experience in establishing diagnostic or biomarker testing operations for clinical trial support
  • 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:

  • Operating at pace and agile decision-making using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness
  • If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-###-#### (US Toll Free) or +1 801 ### #### (outside US).

    GSK is an Equal Opportunity/Affirmative Action Employer. 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.

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    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.

    Associated topics: bacteria, biopharma, histotechnologist, immunology, nephrology, nutritionist, pharmacy, protein, toxicologist, vaccine

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