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As Clinical Biomarker Lead you will be responsible for developing, integrating, and implementing biomarker strategies for Oncology clinical development programs, including validation and integration of biomarker assays into clinical trials. You will contribute to the operational and scientific leadership for the Clinical Biomarkers Group whose objectives are to determine mechanism of action, activity and relevant biological effects in patients. In addition, you will collaborate closely with the Companion Diagnostics group to guide and implement strategies and assays that will advance patient stratification and further development of predictive diagnostics. You will also be expected to form working relationships with the Translational Research, Discovery, Epigenetics, and Cell Therapy Groups within the Oncology therapeutic area, as well as early clinical development teams, safety, and clinical pharmacology groups.

This Associate Director-level role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

  • In collaboration with individuals from Translational Research, Clinical Development and Oncology Cell Therapy groups, evaluating scientific research and technology to identify, define and implement the primary biomarker strategy in support of clinical asset development.
  • Acting as the key point of contact to clinical teams within Oncology, driving fully-developed asset-specific biomarker strategies.
  • Leading the writing and editing of the biomarker sections of the clinical protocol, study procedural manuals and consent forms.
  • Ensuring successful implementation of biomarker strategies in compliance with GSK policies and procedures including the Human Biological Sample Management. These include SOP development, appropriate language for protocol and consent forms, data standards, assessment of biomarker research proposals.
  • Interacting with Oncology clinical sites and partners to ensure accurate and appropriate clinical sample collection to support the biomarker strategy.
  • Establishing links with external experts to initiate and expedite biomarker initiatives in oncology clinical trials.
  • Representing the Clinical Biomarkers Group at internal and external meetings.
  • Partnering with colleagues in the Translational Research, Precision Medicine, and Cell Therapy groups to address translational medicine questions with samples acquired through clinical trials.
  • Contributing to group's awareness of the emerging key scientific and technical innovations to help drive our continuous improvement
  • Working with members of Precision Medicine to implement development of companion diagnostics test to support the Oncology portfolio of clinical assets.
  • Why you?

    Basic Qualifications:

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

  • Experience in immunology, molecular biology, molecular oncology, or pathology
  • For an individual with a BA/BS or MA/MS, a minimum of 5 years of experience in translational or clinical research
  • For an individual with a Ph.D., a minimum of 2 years of industry experience with experience in translational or clinical research
  • Specific experience in the application of biomarkers to clinical translational research in industry during the development process of Immuno-Inflammation, Oncology or Immuno-Oncology assets, Pivotal PhII/III preferred.
  • A proficient understanding of immunology and immunotherapy
  • Preferred Qualifications:

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

  • Ph.D. in immunology, molecular biology, molecular oncology, or pathology
  • Experience in managing research collaborations, contract laboratories and budgets
  • Experience in a matrix environment
  • Why GSK?

    Our values and expectations are at the heart of everything we do and form an important part of our culture.

    These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Agile and distributed decision-making using evidence and applying judgement to balance pace, rigour and risk.
  • Managing individual and team performance.
  • 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.
  • If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-###-#### (US Toll Free) or +1 801 ### #### (outside US).

    GSK is an Equal Opportunity/Affirmative Action Employer. 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 does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

    Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK s compliance to all federal and state US Transparency requirements. For more information, please visit GSK s Transparency Reporting For the Record site.

    Associated topics: aseptic, bacteria, cytometry, drug, food, histology, immuno oncology, immunology, physiology, therapeutic

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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