Clinical Biomarker Director

Full Time
Collegeville, PA 19426
Posted
Job description
Site Name: UK - Hertfordshire - Stevenage, Upper Providence, USA - Pennsylvania - Upper Providence
Posted Date: Mar 22 2023


Clinical Pharmacology & Experimental Medicine (CPEM) serves as a translational bridge between GSK research units and late clinical development. We leverage expertise in human disease, clinical pharmacology, biomarkers, imaging, and experimental medicine to define the optimal destination for cutting edge science to impact patient lives. It is under this umbrella that Clinical Biomarkers resides.

Are you passionate about science and wanting to make a difference to patients’ lives?

At GSK science is at the heart of everything we do. Join us to translate that great science into therapies as a Clinical Biomarker Lead Director.

In this role, you will have responsibility for development and effective implementation of biomarker and precision medicine strategy in support of clinical development of assets. Working as part of the early development / medicine development matrix teams (EDT/MDT), the Clinical Biomarker Leader will establish clear decision-making criteria to enable informed clinical decisions, identify patient segmentation strategies and integrate the strategy into the clinical development plans. You will employ cutting edge technologies and methods 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 and identification of the right patient population for our medicines.

This role will provide YOU with the opportunity to progress YOUR career, and your responsibilities include:

  • Develop and deliver biomarker strategies including approaches to pharmacodynamic biomarkers, proof-of-mechanism biomarkers, for clinical phase programs to enable informed clinical decisions.

  • Develop and deliver precision medicine strategy to identify predictive biomarkers to enable clinical success and differentiation.

  • Represent biomarker strategy at EDT/MDT, study teams and at internal governance reviews as well as serve as biomarker point of contact for clinical studies.

  • Ensure alignment of biomarker outputs with clinical team to meet study requirements.

  • Lead writing of reports to support study teams and regulatory submissions as well as contribute to publications.

  • As required, supporting the expansion of mechanism and disease understanding to generate insights that can be leveraged for indication expansion and scientific exchange.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Minimum of 5 years relative experience with strong background in translational research and experience/track record in the application of biomarkers in clinical trials.

  • PhD scientific area of concentration.

  • Expertise in a specific research area/biomarker technology.

  • Experience in conducting clinical trials and working as part of a clinical study team.

  • Experience in cellular/molecular biology technologies, techniques, and data analysis.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

  • Experience in High dimensional dataset analysis.

  • Experience in conducting clinical trials and working as part of a clinical study team including working to GCP principles.

  • Experience with identifying predictive biomarkers and/or diagnostic development.

  • Preference will be given to candidates with experience and knowledge of dermatology, immunology and/or inflammatory disease. Ability to analyze and interpret molecular data sets.

  • Ability to solve problems.

  • Strong writing and presentation skills.

  • Strong interpersonal skills and ability to thrive in a team setting.

  • Ability to influence teams and key leaders with a proven track record of success.

Why GSK?

At GSK, we're a company with a purpose to help people do more, feel better and live longer. We realize that our purpose starts with us. When we feel at our best, we perform at our best. Therefore, we want all applicants to be able to perform their best throughout the recruitment process.

We will be delighted to hear from talented individuals that align to our values. These are at the heart of everything we do and include: Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.

When you set out on your adventure at GSK, we make a deal. You commit to living our values and expectations and performing against our Innovation, Performance and Trust priorities. In return, GSK commits to providing the right environment for you to thrive. Together, we build an environment where we can all thrive and focus on what matters most to each of us.

As a modern employer, we empower you to be yourself, share ideas and work collaboratively.

#LI-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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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