Director, Clinical Biomarkers in Oncology Experimental Medicine - Oncology / Myeloma
- Collegeville, PA
Site Name: USA - Pennsylvania - Upper Providence
Posted Date: Dec 21 2020
Are you an experience leader in lmmuno-Oncology Biomarker Manager looking to be part of an innovative, dynamic and growing organization? If yes, GSK's Immuno-Oncology Biomarker team is looking for you.
Being part of Oncology at GSK is being part of something special. The focus of the organization couldn't be clearer - we are fueled by a personal passion to give our customers patients MORE. More of ourselves, more to fight for and more moments that matter!
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 immune-biomarker experience
- Minimum of 10 years of experience in the application of biomarkers in Oncology clinical trials
Preferred Qualifications: If you have the following characteristics, it would be a plus:
- 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
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:
- Operating at pace and agile 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.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being.
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness.
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