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Clinical Biomarkers Director
2 months ago
We are seeking a highly skilled Clinical Biomarkers Director to lead the development of clinical biomarker strategies and drive the implementation of biomarker-driven decision-making criteria to enable clinical development. The ideal candidate will have extensive experience in oncology translational research and a proven track record of success in leading matrix team structures across functional disciplines.
Key Responsibilities- Develop and execute 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.
- 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.
- Bachelor's degree in oncology, immunology, or a related discipline required; PhD preferred.
- 7+ years of experience in Clinical Biomarkers and Translational Research.
- 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.
Why GSK?
GSK is a global biopharma company with a special purpose – to unite science, technology, and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.
We prevent and treat disease with vaccines, specialty, and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/immunology, and oncology).
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged, and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing.
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status, or any other federal, state, or local protected class.
