Director, Clinical Biomarkers

5 months ago

Waltham, United States 1925 GlaxoSmithKline LLC Full time

GSK site preferred locations: US - Waltham, MA,Upper Providence, PA. UK – GSK House, Stevenage. Switzerland. On-site presence of 2-3 days per week average is anticipated. Additional flexible arrangements considered on case by case basis.

Leading the conceptualization, alignment and delivery of Clinical Biomarker Strategies on behalf of Precision Medicine

Representing Precision Medicine at Medicine Development Teams (MDT) and/or Clinical Matrix Teams (CMT) establishing clear biomarker driven decision-making criteria to enable clinical development.

Identify cutting edge science and technological advances and incorporate them into biomarker strategies to guide indication selection, patient enrichment, and combination strategies.

Develop translational analysis plan and ensure its seamless incorporation into clinical study design and alignment with clinical study objectives.

Oversight and/or development of sample testing plan and delivery of high-quality biomarker data packages to inform clinical development and regulatory strategy.

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 company through contributions to the scientific literature (publications/presentations)

Establish and deliver budget plans for biomarkers to MDT.

Working with Research Unit biology leads and Precision Medicine Companion Diagnostic leads to ensure alignment of preclinical, clinical biomarker and CDx strategies

Basic Qualifications:

Bachelor’s degree in oncology, immunology or a related discipline required. PhD preferred.

7+ years of experience in Clinical Biomarkers and Translational Research

Preferred Qualifications:

Expertise in leading the development of clinical biomarker strategies with a proven track record of success

Extensive experience in oncology translational research, with 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

#LI-GSK

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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.

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.

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