Senior Director, Companion Diagnostics - Oncology

    • Waltham, MA

Site Name: USA - Massachusetts - Waltham
Posted Date: Mar 18 2020
Are you energized by a scientific leadership opportunity that allows you to develop medicines and shape the scientific program for a growing pipeline? If so, this Sr Director Companion Diagnostics (Oncology) role could be an ideal opportunity to explore.

As a Sr Director Companion Diagnostics (CDx) , you will be delivering 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/gives YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...

  • Defining the CDx strategy from a portfolio and asset perspective to support global drug registration
  • Lead the companion diagnostics strategy within 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
  • Identify and 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 team's 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 7 years of pharmaceutical and IVD manufacturer experience or M.S. with 15+ years of 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)
  • 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 devices
  • 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 CDx test placement
  • Understanding of GCP/GCLP, CLIA, CAP, ISO15189 laboratory requirements
  • Understanding of CLSI, NYDOH and other industry standards for assay validation
  • Understanding of IVD regulations including QSR regulations, GMP manufacturing, ISO13485, and FDA and EU medical device regulations
  • Able to integrate and synthesize development and commercial CDx strategy for Sr Management communication
  • 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 FDA, EMA and other regulatory bodies for CDx developments
  • Experience with SAP development and diagnostic analysis required to support regulatory submissions
  • Experience in supporting BIMO audits and other health authority audits
  • Experience in more than one therapeutic area preferable
  • Experience managing and developing others
  • Experience in supporting CDx developments in ex-US countries, particularly China, Japan, Korea.
  • Experience in supporting CDx commercial activities including pre and post launch activities

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, governance and control, managing ambiguity and paradox.
  • Managing individual performance.
  • Creating a performance culture and driving results, prioritisation, execution, delivering performance.
  • Setting strategic direction and leading on-going organisational transformation.
  • Building a resilient organisation. Building strong relationships and collaboration in service of common goals, engaging the organisation and building trusted external networks for mutual benefit.
  • Managing P&L and capital allocation.

*This is a job description to aide in the job posting, but does not include all job evaluation details.

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