Clinical Program Lead, Immunology

7 months ago

Pu Dong Xin Qu, China 10287 GlaxoSmithKline (China) R&D Company Limited Full time

Summary:

Responsible for integrating clinical development strategy with global considerations into strategic business decisions. Responsible for oversight of development and execution of studies linked to worldwide clinical development plans for assigned programs in assigned portfolio.  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). Ensures clinical, operational and medical governance excellence across all clinical development projects for assigned programs. Evaluates the efficacy and safety of drugs in human clinical studies. (Phases I to IV) involving patient interaction and/or research, consulting, bench work and/or analysis. Provides medical expertise to ensure the proper development of new products and the optimal positioning and promotion of existing products. Medical governance for responsible clinical program in China.

Key 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. 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. May lead TMT/IET to 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. As line manager, coach and develop clinical team of study physicians/scientists.

Qualification Requirements:

MD, PhD or PharmD degree with > 5 years of experience in medical practice and/or scientific research in the relevant field. > 8 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, operationalization, 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 analyze 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 Experience of change management and leading teams through change. Proven ability to communicate effectively with credibility, accuracy, and confidence with internal and external stakeholders. Proficiency in English

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.


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