Associate Director, Clinical Biomarker Lead
1 week ago
Posted Date: May
The Associate Director, Clinical Biomarker Lead will lead and/or contribute to the clinical asset biomarker strategy within early and late-stage clinical development programs to generate data that informs on target engagement, pharmacodynamics, mechanism of action and patient selection.
We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK
Job responsibilities include , but are not limited to,
- Lead and/or contribute to clinical asset biomarker strategy within early and late-stage clinical development programs to generate data that informs on target engagement, pharmacodynamics, mechanism of action and patient selection.
- Represent Clinical Biomarker team at Clinical Matrix 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 with robust assay validation. 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 and analysis including from high dimensional assays. Execute sample testing plan and deliver high quality biomarker data packages to inform clinical development and regulatory strategy.
- Lead writing of reports to support study teams and regulatory submissions as well as contribute to publications
- Collaborate with clinical operations and sample management to ensure biomarker testing and data generation while being a point of contact for resolving study biomarker issues.
We are looking for professionals with these required skills to achieve our goals,
- MA/MS with extensive experience in the pharmaceutical industry setting in the application of biomarkers in clinical trials preferably in Respiratory and Immunology disease areas.
- Experience in contributions to biomarker discovery and/or assay development
- Experience in conducting biomarker analyses on various clinical sample types and working as part of a clinical study team
If you have the following characteristics, it would be a plus,
- Experience in managing research collaborations, contract laboratories and budgets.
- Demonstrated scientific capability as evidenced by publications, research reports, and external presentations.
- Correlative Science Experience
- Up to date knowledge and deep understanding of major molecular and genomic assay technologies and platforms
- Experience with clinical flow cytometry, immunohistochemistry and/or immunoassay development
- Knowledge and track-record of working to GCP principles
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the 'cover letter' of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.
Find out more:
Our approach to R&D .
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
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. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, 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*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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