Clinical Biomarker Lead- Oncology Translational Medicine

GSK•Waltham, PA

9d•Hybrid

About The Position

This role is for an Associate Director of Biomarkers in Oncology Translational Medicine (OTM) at GSK. The position involves leading the development and implementation of biomarker strategies to support clinical development across GSK's portfolio. The individual will be a key contributor in developing novel biomarkers for clinical trials and serving as a biomarker lead on clinical matrix teams, integrating biomarker strategies into clinical development plans. GSK's R&D focuses on discovering and delivering vaccines and medicines, combining an understanding of the immune system with cutting-edge technology to transform lives. The company aims to positively impact the health of 2.5 billion people by the end of the decade.

Requirements

Ph.D. or equivalent with 3+ years or M.Sc with 7+ years of drug development experience in pharmaceutical industry preferably in oncology biomarker development.
Experience with biomarker assays, technologies, platforms and providers.
Experience of implementation of a range of biomarker platforms including flow cytometry, molecular diagnostics (NGS, FISH, PCR), and/or IHC/IF for Oncology clinical trials.
Experience designing and executing translational biomarker strategies in oncology clinical trials, including assay development, validation, sample testing plans and clinical deployment.
Experience conducting biomarker analyses on various clinical sample types and delivering biomarker data packages at pace to inform clinical development and regulatory strategies working collaboratively as part of cross-functional matrix teams.
Experience coordinating and managing key deliverables, timelines, contracts and budgets with internal and external partners.
Experience working to GCP/GLP principles.
Experience managing multiple priorities and delivering projects within established timelines in a fast-paced environment.

Nice To Haves

Strong interpersonal skills and ability to thrive in a matrix environment.
Dependable and trustworthy, willing to take ownership and responsibility.
Experience with high-dimensional dataset analysis.
Strong communication, organizational, matrix project-management, and presentation skills.
Experience with digital pathology, AI/ML-enabled biomarker analyses, and external scientific partnerships.

Responsibilities

Work with key external industry and/or academic partners to evaluate, validate and establish key biomarker capabilities and/or generate key biomarker data to support biomarker strategies for clinical trial implementation at GSK.
Design, implement and manage collaborative projects that aid in developing biomarker capabilities that are of strategic importance to OTM and in alignment with GSK clinical trials.
Identify, develop and implement cutting edge advances in science and technology into biomarker strategies to guide indication selection, patient enrichment, and combination strategies.
Provide input to clinical biomarker teams on novel technologies that will enable clinical development of GSK candidate drugs.
Manage effective working relationships with clinical biomarker leads, medical affairs, oncology tumor teams, portfolio management, competitive intelligence, clinical development and OTM management.
Coordinate and manage biomarker projects with cross-functional internal stakeholders and external partners.
Contribute to and ensure the quality of OTM biomarker reports, summaries, data reviews and interpretations as applicable.
Present key data/findings/accomplishments at internal as well as external scientific forums, lead the preparation and publication of scientific manuscripts as needed.