Are you interested in developing, integrating, and implementing innovative biomarker strategies for Oncology Cell and Gene Therapy clinical development programs, including validation and integration of biomarker assays into clinical trials? If so, the Associate Director, Clinical Biomarkers Cell and Gene Therapy role within Experimental Medicine Unit (EMU) could be an ideal opportunity to explore.
This role will provide YOU
the opportunity to lead key activities to progress YOUR career.These responsibilities include some of the following :
Why You? Basic Qualifications:
- Lead and/or contribute to clinical asset biomarker strategy within early and late stage clinical development programs in Cell and Gene Therapy to generate data that informs on target engagement. pharmacodynamics, mechanism of action and patient selection.
- Represent EMU Biomarker team at Clinical Matric Teams (CMT) and clinical trial study teams (ST). As part of the CMT and clinical ST, establishing clear decision-making criteria to enable biomarker-informed clinical decisions.
- Develop and implement novel biomarker assays
- Provide input to clinical teams on biomarker-related elements of clinical protocols, lab manuals and consent forms.
- 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.
- Collaborate with Research groups within the Oncology therapeutic area, as well as Clinical Safety and Clinical Pharmacology groups
- 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
- Ph.D. or equivalent with minimum of 2 years or MA/MS with minimum 5 years of relevant experience in pharmaceutical industry setting in the application of biomarkers in clinical trials preferably in Oncology and Cell Therapy
- One or more years experience in conducting biomarker analyses on various clinical sample types and working as part of a clinical study team
- One or more years experience working in matrixed, multidisciplinary teams
- One more years experience working in a matrixed tream environment.
If you have the following characteristics, it would be a plus:
Why GSK? *LI-GSK
- Deep understanding and experience working in the Cell Therapy field and engineered T -cells (TCR-T/ CAR-T cells)
- Experience in high-impact contributions to biomarker discovery and/or assay development
- Experience in Correlative Science
- Deep knowledge of immuno-oncology biology, biomarker strategies and application to clinical trials
- Experience in managing research collaborations, contract laboratories and budgets
- Demonstrated scientific capability as evidenced by publications, research reports, and external presentations.
- Effective verbal and written communication skills relating to colleagues and associates both inside and outside the corporation
- Flexibility to work on multiple projects as the portfolio evolves over time.
- Up to date knowledge and deep understanding of major molecular and genomic 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
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