1+ months

Associate Director, Companion Diagnostics (Oncology)

Waltham, MA 02452
Site Name: USA - Massachusetts - Waltham
Posted Date: May 15 2020

Are you energized by a highly-visible scientific leadership role that allows you to drive and shape scientific innovation? If so, the Associate Director, Companion Diagnostics role could be an exciting opportunity to explore.

In this role, you will act as a Companion Diagnostics (CDx) team member to help position GSK as 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 CDx strategy including technical, clinical, regulatory, commercial, intellectual property and business development components by leading CDx projects and work streams according to agreed deliverables, timelines and budget.Partners with aforementioned functional areas to develop and commercialize companion diagnostics across therapeutic areas with a focus on oncology.

CDx team members execute precision medicine approaches in drug development through building collaboration between groups that work in the biomarker continuum within GSK and with external, diagnostic partner companies.


The CDx associate director will be responsible for the following:

  • Lead CDx strategy within early and late stage therapeutic programs to align CDx 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 working closely with the GSK translational, clinical, regulatory, policy, medical affairs, and commercial teams.
  • Oversee technical aspects of development, assay validation and clinical implementation of the
    selected assays
  • Author CDx portions of informed consents, clinical protocols, schedule of clinical activities, clinical study reports, IDE and PMA regulatory submissions, as needed.
  • Collaborate with clinical operations and sample management to ensure diagnostic testing and data generation is compliant with regulatory requirements
  • Help establish strategic external partnerships to deliver diagnostic solutions to support the pipeline
  • Must be able to manage multiple projects and work streams, including balancing workload, resourcing requirements and delivery of projects/work streams within agreed budget and timeline
  • Clearly and concisely report project progress and outcomes related to CDx deliverables, 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 through joint project teams with asset teams, including regulatory, clinical and biomarker eads, therapeutic area heads, and IVD partner

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Advanced degree in Biological sciences; either Ph.D. with 3-5 years, or M.S. with minimum 5 years of pharmaceutical experience, including IVD development. .
  • Understanding of drug discovery & development, especially late stage development, regulatory 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 IVD development including design history file evaluation, risk assessments and related analytical and clinical validation requirements
  • Experience performing due diligence and auditing vendors for test placement
  • Understanding GCP/GCLP, CLIA, CAP, ISO15189 laboratory requirements
  • Understanding QSR regulations, GMP manufacturing, ISO13485, and FDA and EU medical device regulations
  • Must be detail oriented with strong organization skills to manage and meet deliverables
  • Understanding 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
  • 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:

  • 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/ 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 GSKs compliance to all federal and state US Transparency requirements. For more information, please visit GSKs Transparency Reporting For the Record site.

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Posted: 2020-05-18 Expires: 2020-07-17

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Associate Director, Companion Diagnostics (Oncology)

Waltham, MA 02452

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