Clinical Biomarker Lead, Virologist (CPEM), Open to flexible working

4 days left

Stevenage, Hertfordshire
28 Apr 2021
12 May 2021
Contract Type

GlaxoSmithKline is a world leading research-based pharmaceutical company that combines both individual talent and technical resources to support our mission to improve the quality of human life by enabling people to do more, feel better and live longer.

The Clinical Biomarker Lead will have responsibility for development and effective implementation of biomarker strategy in support of project clinical development. Working as part of the early development / medicine development matrix teams (EDT/MDT), the clinical biomarker lead will establish clear decision-making criteria to enable informed clinical decisions and integrate the biomarker strategy into the clinical development plans. The Clinical Biomarker Lead will employ cutting edge technologies and procedures to discover and clinically validate biomarkers. The implementation of the biomarker strategy as part of a well thought through clinical plan will ensure optimally informed decision making in drug development.

Key Responsibilities include, but are not limited to:

  • Developing and maintaining project clinical biomarker strategy including approaches to pharmacodynamic and predictive biomarkers.
  • Representing biomarker strategy at the EDT/MDT, study teams and Protocol Review Forum.
  • Providing input to clinical teams on biomarker-related elements of study trial design and conduct and incorporating biomarkers into clinical protocols, Study Reference Manuals and Central Lab Worksheets.
  • Working with clinical teams to ensure virology assays and data outputs are adequate to meet study requirements.
  • Establishing and delivering budget plans for biomarkers to EDT/MDT.
  • Working with Research Unit project biologist to ensure alignment of preclinical and clinical biomarker strategies.
  • Working with internal technology groups, Contract Research Organisations and collaborators to deliver clinically validated biomarker assays into clinical studies.
  • Developing companion diagnostic strategies for validation, implementation and regulatory approval of predictive biomarkers.
  • Ensuring alignment of biomarker outputs with data management, statistics, and modelling/simulation requirements.
  • As part of the EDT/MDT establishing clear decision-making criteria to enable informed clinical decisions.
  • Point contact for resolving study biomarker issues.
  • As required, contributing to the study design, biomarker implementation and analysis of observational studies, Investigator Sponsored Studies and collaborative/consortia approaches.
  • As required, supporting the expansion of mechanism and disease understanding of approved drugs to generate insights that can be leveraged in indication expansion and marketing.
  • Lead writing of virology reports to support study teams and submissions.
  • Interact with regulatory organisations, such as FDA and EMA, with one to one interactions, reports, submission documents and label changes.
  • Contribute to virology and biomarker sections of publications.
  • Provide virology expertise to GSK departments on virology documents e.g. Medical Affairs.
  • Provide expert advice on resistance to antiviral assets.
  • Must have an in-depth knowledge of virology assays for respiratory viruses and hepatitis B virus and keep up to date with developing technologies.

Closing Date for Applications: 12th May 2021 (COB)

Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

During the course of your application you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

Why you?

Basic Qualifications:

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

  • Scientist and/or Physician (PhD, MD or equivalent) with extensive experience in the application of biomarkers in clinical trials.
  • Expertise in the development of clinical biomarkers with a proven track record of success.
  • Expertise in either a specific research area and/or biomarker technology.
  • Experience in conducting clinical trials and working as part of a clinical study team.
  • Knowledge and track-record of working to GCP principles.
  • Expertise in the discovery, validation and clinical implementation of biomarkers.
  • Strong understanding and experience of predictive biomarkers, including diagnostic development.
  • Knowledge and experience of biomarker technologies and their clinical implementation.

Preferred Qualifications:

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

  • Strong interpersonal skills and ability to thrive in a matrix environment.
  • Ability to influence teams and key stakeholders with a proven track record of success.

Note: Preference will be given to candidates with experience and knowledge of virology.

Why GSK?

Our values and expectations are 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.

At GSK, we're a company with a special purpose, to help people do more feel better and live longer. Realising our purpose starts with us. When we feel at our best, we perform at our best.

When you set out on your adventure at GSK, we make a deal. You commit to living GSK's values and expectations and performing against our Innovation, Performance and Trust priorities. And in return, GSK commits to providing the right environment for you to thrive. Put simply, it's about you being motivated to do your best work, in a place where you can be you, feel good and keep growing.

Together we build an environment where we can all thrive and focus on what matters most to each of us. It is only through the energy, dedication, drive and passion of all of us that we can be the very best for GSK, and importantly, for our patients and consumers.

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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