Clinical Biomarkers Director

2 months ago

Stevenage, Hertfordshire, United Kingdom 1925 GlaxoSmithKline LLC Full time
Job Description

Job Summary:

We are seeking a highly experienced Clinical Biomarkers Director to lead the development of clinical biomarker strategies for our Precision Medicine team. The successful candidate will have a strong background in oncology translational research and a proven track record of success in leading matrix team structures.

Key Responsibilities:

  • Develop and implement clinical biomarker strategies to guide indication selection, patient enrichment, and combination strategies.
  • Represent Precision Medicine at Medicine Development Teams (MDT) and/or Clinical Matrix Teams (CMT) to establish clear biomarker-driven decision-making criteria.
  • Identify cutting-edge science and technological advances and incorporate them into biomarker strategies.
  • Develop translational analysis plans and ensure seamless incorporation into clinical study design and alignment with clinical study objectives.
  • Oversee and/or develop sample testing plans and deliver high-quality biomarker data packages to inform clinical development and regulatory strategy.
  • Manage effective working relationships with clinical operations, medical science, medical affairs, regulatory, portfolio management, and commercial functions.
  • Establish and manage external collaborations with leading academic groups, diagnostic partners, and CROs.
  • Contribute to scientific credibility of the company through contributions to the scientific literature (publications/presentations).
  • Establish and deliver budget plans for biomarkers to MDT.
  • Work with Research Unit biology leads and Precision Medicine Companion Diagnostic leads to ensure alignment of preclinical, clinical biomarker, and CDx strategies.

Basic Qualifications:

  • Bachelor's degree in oncology, immunology, or a related discipline required. PhD preferred.
  • 7+ years of experience in Clinical Biomarkers and Translational Research.

Preferred Qualifications:

  • Expertise in leading the development of clinical biomarker strategies with a proven track record of success.
  • Extensive experience in oncology translational research, with a proven track record of high-impact contributions to biomarker discovery and implementation of biomarker strategy into clinical development.
  • Demonstrable leadership of matrix team structures across functional disciplines.
  • Experience in conducting clinical trials and working as part of a clinical study team and other matrix teams.
  • Ability to influence teams and key stakeholders with a proven track record of success.
  • Experience with authoring clinical and regulatory documents.
  • Having a strong sense of urgency and excellent skills in prioritization, planning, as well as timely execution in a very fast-paced environment.
  • Up-to-date knowledge and deep understanding of major molecular and genomic assay technologies and platforms.
  • Deep knowledge of immuno-oncology biology, biomarker strategies, and application to clinical trials.
  • Knowledge and track-record of working to GCP principles.
  • Strong interpersonal skills and ability to thrive in a matrix environment.

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