Clinical Biomarker Lead

Collegeville, Pennsylvania
Closing date
Oct 3, 2022

View more

Health Sciences, Medicine
Organization Type
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.

We seek experience within one of these areas: Neurosciences, NASH, Immunology.

Primary Responsibilities and Accountabilities:
  • 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
  • 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

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 at least 1-3 years of experience in the application of biomarkers in clinical trials.
  • Experience within the Neurosciences, NASH, or Immunology.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Expertise in the development of clinical biomarkers
  • 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
  • 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

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:
  • 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.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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 GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert