Clinical Development Scientist - Oncology
Reporting to the Medical Director, Therapeutic Area, the Clinical Development Scientist, aligned by asset, will work closely with the MDL/PPL/PT in the development and global execution of the clinical development plan including regulatory submissions and life-cycle plans. In addition, you would work closely with the other global team functional leads and Regional Heads to provide "enterprise thinking" in the development of the overall Oncology portfolio.
You will be expected to have a strong scientific and clinical research background and be able to take a lead role in the clinical and scientific responsibilities of oncology clinical trials.
• Provide strategic leadership for the development of an asset or portfolio of assets.
• Execute the broad strategy and vision of the organization through the leadership of a multi-disciplinary matrix team within the R&D organization.
• Help to define and mitigate key development risks of a compound.
• Work closely with functional lines to evaluate and identify key clinical and pre-clinical data required for decisions around medicine development.
• Facilitator of decision-making both within the project team and with external stake-holders.
• Accountable for quality, timely, and on-budget delivery of the asset clinical development plan and studies
• Direct study responsibility, if required
• Collaboration with the MDL & PPL(s) to plan and implement strategy to address asset program requirements in alignment with Oncology R&D goals
• Excellence in the clinical research staffs contribution to successful regulatory approvals, reimbursable medicines, and lifecycle management
• Identification and sharing of best practices with oversight for the implementation of these best practices into business processes
• Close collaboration with other matrixed functions for in-stream, end-to-end process flow, document preparation, data review and submissions.
• Creation and fostering of strong strategic partnerships with key internal stakeholders and strategic external partners
• Bachelors Degree
• Minimum of 10 years of relevant clinical drug development experience
• Demonstrated ability to lead in a heavily matrixed environment
• Ability to influence staff and stakeholders to adapt to positive change
• Master's degree or beyond
• Comprehensive knowledge of asset and asset strategy highly recommended
GSK Oncology R&D
Oncology is an area of high unmet medical need, providing fertile grounds for rapid growth. The lack of effective therapies for most of the advanced cancers, coupled with substantial progress in basic cancer biology and new technologies, provide unparalleled potential for innovation and transformational science. Oncology R&D is focused on building industry-leading portfolios in 3 cutting-edge areas of science: Immuno-Oncology, Cancer Epigenetics, and Cell Therapy. Our vision is to achieve a long-term leadership position in Oncology by delivering Transformational Medicines that Maximize Patient Survival.
• Immuno-Oncology is the use of the human immune system to treat cancer. Several modalities stimulating the immune system are now being investigated with remarkable success. Our IO portfolio has also progressed into the clinic, with novel check point modulators targeting OX40 and ICOS poised to have broad clinical applicability. The recent FTIH of GSK1795091A (TLR4), an activator of the immune system, has potential as an immunologic adjuvant with our OX40 and potentially other checkpoint inhibitors. Our antibody drug conjugate (ADC) targeting B-cell maturation antigen (BCMA) shows encouraging early signs of clinical efficacy in multiple myeloma.
• Targeting epigenetic pathway provides a fundamentally new approach to treating cancer by altering essential aspects of the cancer cell state or wiring. The Cancer Epigenetics DPU has advanced four novel assets into the clinic (BET, EZH2, LSD1 and PRMT5) and we are beginning to see signs of early clinical efficacy.
• Thru a strategic alliance with Adaptimmune, an autologous, engineered cell product expressing an affinity matured T cell receptor (TCR) targeting NY-ESO-1 is advancing our Oncology cell therapy effort in the clinic.
Overall, Oncology R&D has an exciting portfolio with several opportunities for first or best in class monotherapy agents in addition to significant opportunities for potentially transformative combination therapies. Our strategy is to foster innovation and leverage internal and external partnerships to enable combinations and accelerate development.
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