Clinical Program Lead, Oncology Shanghai Site Name: China - Beijing - ChaoYang District - Ocean International Centre - Tower A, China - Shanghai - PuDong New District - Lane 999 Huanke Road - Building18 Posted Date: Nov 5 2020 Role Purpose ? Single point of accountability at clinical program level for the China specific components of Integrated Evidence Plan (IEP) from China Commit to Project (C2P) through Life Cycle of medicine. Scientific and strategic leadership in clinical program planning and execution. Key contributor on the China Therapy area Medicine Team (TMT)/Integrated Evidence Team (IET). Responsible for making clinical development recommendations for evaluations by CMDR and China PIB.
Key deliverables include: China components of Global IEP for the programme in scope that is aligned with the Global Life Cycle strategy of the medicine and fit for purpose for China China components of Clinical strategy/ Development Plan for the program in scope that is aligned with IEP Overall benefit/risk of the medicine... for the indications in scope Medical governance for responsible clinical program in China Key Accountabilities/Responsibilities ? Provide clinical leadership and asset/disease expertise for the clinical trial program and indications in scope Provide scientific and strategic input to China component of IEP for the program Provide matrix leadership at program level to ensure integrated approach, robust planning and execution oversight; may lead TMT/IET Deliver robust trial design, protocols, study reports and appropriate data interpretation required for local registration, PAC and other Ph4 studies through collaboration on TMT Responsible for timely assessment and mitigation of risks associated with clinical trial and scientific content delivery at program level Responsible for medical governance for the clinical program in scope Clinical lead for the program for external collaborators, regulatory agencies and GSK Global, as appropriate. Responsible for making recommendations to TAL/IET Leader and senior stakeholders on benefit risk assessment, Go/No-go criteria, and Clinical PoS for the program in scope Line manage, coach and develop clinical team of study physicians/scientists Why you? Basic Qualifications: MD, PhD or PharmD degree with > 5 years of experience in medical practice and/or scientific research in the relevant field. >5 years of experience in Pharmaceutical industry, a track record of success in leading clinical development in China and Global Excellent knowledge of GCP and regulatory requirements Strong experience in trial design, planning, operationalisation, reporting and publication Understanding of clinical research methodology to facilitate innovative trial design and clinical plans with credible data-driven decision making Experience in inductive and deductive reasoning, and providing mechanisms to interpret and analyse complex information Relevant expertise in the disease area including biology, potential therapeutic targets, treatment pathways, unmet need and evolving practice Demonstrated ability to incorporate global aspects into strategic and operational decisions Proven ability of strategic thinking, practical problem solving, multidisciplinary collaboration and agile decision making Experience in line management /matrix leadership Proven ability to communicate effectively with credibility, accuracy, and confidence with internal and external stakeholders Proficiency in English
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. This is a job description to aide in the job posting, but does not include all job evaluation details.
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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Clinical Program Lead, Oncology Shanghai GSK Shanghai