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Clinical Biomarker Lead

2 months ago

Stevenage, Hertfordshire, United Kingdom VONQ Full time
Job Description

We are seeking a highly skilled Clinical Biomarker Lead to join our team at Precision Medicine. As a key member of our biomarker team, you will play a critical role in developing, integrating, and implementing innovative biomarker strategies for Oncology clinical development programs.

Key Responsibilities:

  • Lead and/or contribute to clinical asset biomarker strategy within early and late-stage clinical development antibody drug conjugate (ADC) programs to generate data that informs on target engagement, pharmacodynamics, mechanism of action and patient selection.
  • Represent Precision Medicine Biomarker team at Clinical Matrix Teams (CMT) and clinical trial study teams (CST). As part of the CMT and CST, establishing clear decision-making criteria to enable biomarker-informed clinical decisions.
  • Provide input to clinical teams on biomarker-related elements of clinical protocols, lab manuals and consent forms.
  • Develop and implement novel biomarker assays.
  • Provide scientific expertise and technical guidance to enable timely biomarker sample collection.
  • Execute sample testing plan and deliver high-quality biomarker data packages to inform clinical development and regulatory strategy.
  • Point contact for resolving study biomarker issues.
  • Collaborate with clinical operations and sample management to ensure biomarker testing and data generation.
  • Align with the companion diagnostics team to deliver novel precision medicine approaches to select patients for treatment.
  • Serve as a point of contact for external vendors and collaborators in support of data generation.
  • Provide frequent project status updates related to biomarker deliverables.

Requirements:

  • Ph.D with experience working in the pharmaceutical industry on integrated biomarker work within clinical development or combined commensurate levels of experience and MA/MSc.
  • Experience working in the pharmaceutical industry in a professional setting.
  • Experience in the application of biomarkers in clinical trials, preferably in Oncology.
  • Experience in conducting biomarker analyses on various clinical sample types and working as part of a clinical study team.
  • Experience in high-impact contributions to biomarker discovery and/or assay development.
  • Experience working in matrixed, multidisciplinary team environment.

Preferred Qualifications:

  • Deep understanding and experience working in Oncology biomarker strategies and application to clinical trials, preferably in ADC programs.
  • Experience in Correlative Science.
  • Effective verbal and written communication skills relating to key stakeholders including colleagues, associates, and senior leaders both inside and outside of GSK.
  • Experience in managing research collaborations, contract laboratories and budgets.
  • Demonstrated scientific capability as evidenced by publications, research reports, and external presentations.
  • Flexibility to work on multiple projects as the portfolio evolves over time.
  • Up-to-date knowledge and deep understanding of major biomarker assay technologies and platforms.
  • Knowledge and track-record of working to GCP principles.
  • Having a strong sense of urgency and excellent skills in prioritization, planning as well as timely execution in a very fast-paced environment.
  • Strong interpersonal skills and ability to thrive in a matrix environment.

Why GSK?

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

We are committed to creating an inclusive and diverse workplace that reflects the communities we serve. We welcome applications from talented individuals from all backgrounds.

Equal Opportunities Employer:

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.

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