Clinical Program Lead, Oncology

Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D 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 Why you? Basic Qualifications: MD, PhD or PharmD degree with 8-10 years of experience in clinical development/medical practice and/or scientific research in the relevant field. At least 10 -12 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