Director, Translational Research and Innovation

Employer
GSK
Location
Rockville, Maryland; Collegeville, Pennsylvania
Salary
Competitive
Closing date
Oct 3, 2022
Are you interested in the development and effective implementation of biomarker strategy to support clinical development across our Oncology portfolio? Are you searching for a position where you will be working as a key contributor to leading development and integration of novel biomarkers into clinical trials and/or as a biomarker lead on clinical matrix team (CMT) and leading development and integration of biomarker strategy into clinical development plans? If so, the Biomarker Director role within Experimental Medicine Unit (EMU) could be an ideal opportunity to explore.

Key Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
  • Identify, develop and implement cutting edge science and technological advances into biomarker strategies to guide indication selection, patient enrichment, and combination strategies.
  • Work with external industry and/or academic partners to evaluate, validate and establish key biomarker capabilities. Design, implement and manage pilot studies and/or collaborative projects that aid in developing biomarker capabilities that are of strategic importance to EMU and in alignment with GSK clinical trials.
  • Provide input to clinical biomarker teams on novel technologies that will enable clinical development of GSK candidate drugs.
  • Manage effective working relationships with clinical biomarker leads, clinical development and EMU management.
  • Represent Biomarker team at CMT and clinical trial study teams (ST). As part of the CMT and clinical ST, establishing clear decision-making criteria to enable informed clinical decisions.
  • Contribute to the development of the translational analysis plan and ensure its seamless incorporation into clinical study design and alignment with clinical study objectives.
  • 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.
  • Execute sample testing plan and deliver high quality biomarker data packages to inform clinical development and regulatory strategy. Point contact for resolving study biomarker issues.
  • Manage effective working relationships with clinical operations and medical science.
  • Contribute to and ensure the quality of EMU biomarker reports, summaries, data reviews and interpretations. Present key data/findings/accomplishments at internal as well as external scientific forums, lead the preparation and publication of scientific manuscripts as needed.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Ph.D. or equivalent with minimal 5-8 years or M.Sc with minimum 8-11 years of relevant experience in biotechnology or pharmaceutical industry setting in the application of biomarkers in clinical trials preferably in oncology biomarker development.
  • Experience in the development of clinical biomarkers with a proven track record of success
  • Highly experienced in oncology translational research on molecularly targeted therapies or IO therapies, with proven track record of high-impact contributions to biomarker discovery and/or assay development
  • Experience in conducting clinical trials, conducting biomarker analyses on various clinical sample types and working as part of a clinical study team
  • Up-to-date knowledge and deep understanding of major molecular and genomic assay technologies and platforms.
  • Experience in tissue and blood-based biomarker analysis of clinical samples
  • Experience of working to GCP principles


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change.
  • Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Developing people and building a talent pipeline.
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
  • Budgeting and forecasting, commercial and financial acumen
  • Having a strong sense of urgency and excellent skills in prioritization, planning as well as timely execution in a very fast-paced environment
  • Strong interpersonal skills and ability to thrive in a matrix environment
  • Dependable and trustworthy, willing to take ownership and responsibility


Why GSK?

We're uniting science, technology and talent to make a difference in more people's lives, and revolutionizing the way we do R&D.

We're combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated.

Our pipeline currently comprises of more than 60vaccines and medicines across four core therapeutic areas including infectious diseases, HIV, oncology and immunology as well at pursuing other science-led opportunities outside our core areas. Many have the potential to be first or best-in-class opportunities for patients and since 2017, we've delivered 13 major approvals and more than doubled the number of potential new vaccines and medicines in Phase 3 and registration to 23.

In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention.

Find out more:

Our approach to R&D.

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

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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GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

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