Job Description
This Clinical Lead role is created following the AsiaR&D reorganisation, which is shifting as an integrated contributor acrossthe full clinical research and development lifecycle. This role is designed toact as the single accountable person for China-specific clinical strategy andIntegrated Evidence Plan (IEP) on Global Health related programmes and Vaccine& Infectious Disease (VID) related early pipeline programmes. It ensures alignment of clinical plans with regulatory expectations and portfolio priorities.
The role also supports key governance forums (CDB, ASSR) and strengthens data-driven decision-making on clinical strategy, benefit-risk, and investment. This role is critical to enabling China's effective participationin global development and supporting Asia R&D's strategic objectives.
Roles & Responsibilities
- Single point of accountability at clinical program level for the China-specific components of Integrated Evidence Plan (IEP) from Commit to Project (C2P) through Life Cycle of medicine in the vaccine and infectious disease (VID) area.
- Provide medical inputs and support for VID early pipeline projects under Asia Research & Development (R&D).
- Scientific and strategic leadership in clinical program planning and execution. Key contributor on the Therapy area Medicine Team (TMT)/Integrated Evidence Team (IET).
- Responsible for making clinical development recommendations for evaluations by China Development Board (CDB) and Asia Strategic & Scientific Review (ASSR).
- 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 Responsibilities
- Provide clinical leadership and asset/disease expertise for the clinical trial program and indications in scope.
- Provide scientific and strategic input into early development clinical studies and early pipeline projects involving Asia R&D.
- 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/IETLeader and senior stakeholders on benefit risk assessment, Go/No-go criteria, and Clinical PoS for the program in scope.
Basic Qualifications
- Master's degree in clinical medicine, or public health, or medical science
- 5 years of experience in the 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.
Additional Requirements
- 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 and Chinese.
