GSK

Director, Clinical Biomarkers in Oncology Experimental Medicine - Oncology / Myeloma

Employer
GSK
Location
Collegeville, PA
Salary
Competitive
Posted
October 02 2020
Ref
264166
Organization Type
Pharma
Are you interested in the development of novel, integrated biomarker strategies to support projects across clinical development for Oncology? Are you searching for a position where you will be working as a key contributor to clinical matrix team (CMT), medicines development team (MDT) and leading development and integration of biomarker strategy into clinical development plans? If so, the Clinical Biomarker Director role within Experimental Medicine Unit (EMU) could be an ideal opportunity to explore.

This role will provide YOU the opportunity to lead key activities to progress YOUR career.These responsibilities include some of the following:

  • Represent biomarker group at Medicine Development Teams (MDT) and/or Clinical Matrix Teams (CMT). As part of the MDT/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.

  • Provide input to clinical teams on biomarker-related elements of study trial design and conduct and incorporating biomarkers into clinical protocols, lab manuals and consent forms.

  • 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 affair, 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 lead and EMU companion diagnostic lead to ensure alignment of preclinical, clinical biomarker strategies and CDx strategy



Basic Qualifications:

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

  • PhD with at least 5 years of experience or MS/MA with at least 10 years of experience in the application of biomarkers in Oncology clinical trials

  • Expertise in the development of clinical biomarkers 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

  • Highly experienced in conducting biomarker analyses on various clinical sample types

  • Experience in conducting clinical trials and working as part of a clinical study team and other matrix teams

  • Experience with authoring clinical and regulatory documents

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

  • 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.

  • Experience in late stage development and leading biomarker strategies for multiple myeloma clinical trials

  • Knowledge and track-record of working to GCP principles

  • Strong interpersonal skills and ability to thrive in a matrix environment

  • Dependable and trustworthy, willing to take ownership and responsibility



Why GSK?

Our values and expectationsare 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, rigor 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.



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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