Offers “Gsk”

Expires soon Gsk

Clinical Biomarker Manager

  • Collegeville (Montgomery County)
  • HR / Training

Job description

Details:
The successful candidate will develop, integrate, and implement biomarker strategies for IOC development programs. This will include validation and implementation of biomarker assays into clinical trials. He/She will contribute to the operational and scientific leadership for the Clinical Research Group in the IOC and to determine drug mechanism of action, activity and relevant biological effects in patients. In addition, he/she will guide and implement strategies and assays that will aid patient stratification and diagnostic development where appropriate. This candidate will be expected to form close collaborations with the Translational Research, Discovery and Cell Therapy Groups within the IOC DPU, early clinical development teams, safety and clinical pharmacology groups.

The successful applicant's responsibilities will include:

• In collaboration with individuals from Translational Research, Precision Medicine Discovery Research and Cell Therapy groups, evaluate scientific research and technology to identify, define and implement the biomarker strategy to support the clinical development of the IOC assets.
• Act as the key point of contact to the clinical teams within the IOC DPU driving agreed upon biomarker strategies for the clinical teams.
• Lead the writing and editing of the biomarker sections of the clinical protocol, study procedural manuals and consent forms.
• Ensure successful implementation of biomarker strategies in compliance with GSK policies and procedures including the Human Biological Sample Management. These include SOP development; appropriate language in the protocol and consent forms; data standards; assessment of biomarker research proposals.
• Interact with IOC DPU clinical partners and clinical sites to ensure accurate and appropriate sample collection to support the biomarker strategy.
• Serve as a point of contact for external vendors and collaborators.
• Establish links between the IOC DPU and external experts to initiate and expedite biomarker initiatives in oncology clinical trials.
• Represent the Clinical Research Group at internal and external meetings.
• Partner with colleagues in the Translational Research, Precision Medicine, and Cell Therapy groups to address translational medicine questions with samples acquired through IOC's clinical trials.
• Contribute to group's awareness of the emerging key scientific and technical innovations to help drive our continuous improvement
• Work with members of Precision Medicine group to implement development of companion diagnostics test to support the IOC portfolio of clinical assets.

Contact information:
You may apply for this position online by selecting the Apply now button.

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Desired profile

Basic qualifications:
• Masters degree in immunology, molecular biology, molecular oncology or pathology and a minimum of 3 years of relevant industrial experience in translational or clinical research OR a Ph.D. in immunology molecular biology, molecular oncology, or pathology, biology and a minimum of 2 years of relevant industrial experience in translational or clinical research.

Preferred qualifications:
• Specific experience in the application of biomarkers during development of Immuno-Inflammation or Immuno-Oncology assets is preferred, including experience with clinical translational research and implementation.
• An understanding of immunology and developing immunotherapy is also preferred.
• Demonstration of scientific productivity (publications, research reports, presentations etc.)
• Knowledge of developing diagnostics is attractive;
• Experience in managing research collaborations, contract laboratories and budget management.
• Effective verbal and written communication skills relating to colleagues and associates both inside and outside the corporation.
• Ability to productively collaborate with multiple groups

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