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GSK

Develops medicines, vaccines, and consumer health

Director, Oncology Translational Medicine - Clinical Biomarkers

Biology & BiotechUpdated on Nov 9
Full-time

About the Job

Requirements

  • A Ph.D. or equivalent with 7+ years, or an M.Sc. with 10+ years, of drug development experience in the pharmaceutical industry, including a solid background in oncology clinical biomarkers, expertise in late-phase oncology studies, and translational research within clinical development.
  • Strong expertise in cancer biology and clinical development, including the therapeutic landscape, approved and investigational agents, and diagnostic approaches in solid tumor and hematological malignancies.
  • Experience leading cross-functional teams and designing and executing strategic biomarker plans, including development of regulated biomarker assays.
  • Experience conducting clinical trials and working as part of clinical study teams.
  • Experience designing and executing translational biomarker plans for clinical trials, and exploring and onboarding innovative technologies to advance translational research and new biomarker development.
  • Experience collaborating with Data Sciences to analyze high-dimensional preclinical and clinical data to guide clinical decisions and inform asset strategy.
  • Hands-on experience implementing biomarker platforms including flow cytometry, molecular diagnostics such as next-generation sequencing, fluorescence in situ hybridization and polymerase chain reaction, immunohistochemistry/immunofluorescence, liquid biopsy/circulating tumor DNA approaches, and multi-omic biomarker analyses.
  • Experience directly translating preclinical research to human clinical trials, using learnings from genomic, transcriptomic, and proteomic analyses of preclinical models and patient samples.
  • Experience influencing teams and key leaders, with a track record of success.

Responsibilities

  • Collaborate with the Clinical Biomarker Executive Director to drive the design, alignment, and execution of clinical biomarker and translational medicine strategies focused on identifying predictive biomarkers that enable clinical success.
  • Validate and implement target engagement, pharmacodynamic, and proof-of-mechanism biomarker strategies for clinical-phase programs to support patient stratification, dose selection, and clinical go/no-go decisions.
  • Participate in tumor-specific Biomarker Matrix teams and execute clinical biomarker strategies for late-stage oncology programs in collaboration with internal and external stakeholders and disease area strategy teams.
  • Represent Translational Medicine at Clinical Development Matrix Teams to establish biomarker-driven decision-making criteria and integrate them into clinical study designs aligned with study objectives.
  • Support disease area strategies and translational objectives by defining biomarker priorities and areas of interest, and generating decision-enabling evidence packages informed by real-world datasets, internal and external data, and partnerships such as research collaborations and key external expert consultations.
  • Identify scientific and technological advances to incorporate into biomarker strategies for indication selection, patient enrichment, and combination strategies.
  • Oversee and/or develop sample testing plans and deliver biomarker data packages to inform clinical development and regulatory strategies.
  • Manage relationships with clinical and scientific operations, diagnostics, medical science, medical affairs, regulatory, portfolio management, and commercial functions.
  • Support the expansion of mechanism and disease understanding to generate insights for indication expansion and scientific exchange as needed.
  • Define and study mechanisms of resistance to enable reverse translation, inform next-line strategies, support patient enrichment, and influence asset life-cycle management.
  • Contribute to the company’s scientific credibility through publications and presentations.

Desired Qualifications

  • Experience with high-dimensional dataset analysis.
  • Prior experience with diagnostic development and regulatory interactions.
  • Experience with digital pathology, artificial intelligence/machine-learning-enabled biomarker analyses, external scientific partnerships, and mentoring or developing scientific colleagues.
  • Strong skills in prioritization, planning, and timely execution in a fast-paced environment.
  • Strong interpersonal skills and ability to thrive in a matrixed environment; dependability, trustworthiness, and willingness to take ownership and responsibility.
  • Communication, problem-solving, matrix project-management, and presentation skills.

About the Company

GSK

Develops medicines, vaccines, and consumer health

GSK is a global healthcare company focused on three main areas: Pharmaceuticals, Vaccines, and Consumer Healthcare. It develops medicines, vaccines, and consumer health products to improve health outcomes worldwide. Its products address diseases in respiratory, HIV, oncology, and immuno-inflammatory areas; vaccines for influenza, shingles, and COVID-19; and over-the-counter wellness products. The company relies on substantial R&D and strategic partnerships to bring new products to market and to address health needs. Revenues come from sales of medicines, vaccines, and consumer health items, often complemented by patient support programs and collaborations with governments and biotech partners.

Company size
10,001+
Company stage
IPO
Headquarters
London, United Kingdom
Founded
1891

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