Join us today to translate great science into therapies as a Clinical Virology Biomarker Director. In this role, you will have responsibility for development and effective implementation of biomarker strategy in support of project clinical development. Working as part of the early development / medicine development matrix teams (EDT/MDT), the Clinical Virology Biomarker Director will establish clear decision-making criteria to enable informed clinical decisions and integrate the strategy into the clinical development plans. You will employ cutting edge technologies and procedures to discover and clinically validate biomarkers. The implementation of the biomarker strategy as part of a well thought through clinical plan will ensure optimally informed decision making in drug development.
This role will provide YOU with the opportunity to progress YOUR career, these responsibilities include:
- Develop and deliver virology biomarker strategy including approaches to pharmacodynamic biomarkers, disease related biomarkers, clinically validated biomarkers and/or companion diagnostics for clinical phase programs including SARs-COV2, influenza, HBV and/or HRV to enable informed clinical decisions
- Detection and monitoring or viral resistance during treatment and in the global community
- Represent virology biomarker strategy on EDT/MDT, study teams and at internal governance reviews as well as serve as point of contact for study virology biomarker issues
- Providing input to clinical teams on virology issues that may affect clinical studies, e.g. selection and transmission of variants and the effect on the efficacy of the molecule, incidence of viral disease in the community
- Ensure alignment of virology biomarker outputs with data management, statistics, and modelling/simulation requirements to meet study requirements
- Lead writing of virology reports to support study teams and regulatory submissions as well as contribute to virology and biomarker sections of publications
- Interact with regulatory organisations, such as FDA and EMA, with one to one interactions, reports, submission documents and label changes.
We are looking for professionals with these required skills to achieve our goals:
- Scientist and/or Physician (PhD, MD or equivalent) with at least 3-5 years of experience in the application of clinical virology biomarkers in clinical trials
- In-depth knowledge of virology assays for respiratory viruses and/or hepatitis B virus
- Experience and knowledge of viral resistance
- Expertise in the discovery, validation and clinical implementation of biomarkers with a proven track record of success
- Strong understanding and experience with predictive biomarkers
- Knowledge and experience of biomarker technologies and their clinical implementation
- Experience in conducting clinical trials and working as part of a clinical study team including working to GCP principles
- Strong interpersonal skills and ability to thrive in a matrix environment
- Ability to influence teams and key stakeholders with a proven track record of success
If you have the following characteristics, it would be a plus:
- Experience with diagnostic development
*Role can be Director or Associate Director depending on level of experience
GSK offers you the opportunity to showcase your expertise with a leadership that values, recognizes and rewards talent!
~We look forward to working with you!~
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