Therapy Area Leader, Oncology
- Shanghai, China
Site Name: China - Shanghai - PuDong New District - Lane 999 Huanke Road - Building18
Posted Date: Jun 8 2020
Single point of accountability at TA 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 for the Therapy area Medicine Team (TMT) /China Integrated Evidence Team (IET). Accountable for China medicine development recommendations to China DRB, China PIB and Global MDTs.
Key deliverables include:
- China components of Global IEP 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 that is aligned with IEP
- Overall benefit/risk of the medicine for indications developed in China
- Medical governance and project compliance for clinical development in China
- Lead the development and oversee the execution of China components of IEP that is aligned with Life Cycle strategy and Target Medicine Profile for successful drug registration, indication expansion and patient access.
- Provide strategic leadership on TMT/Integrated Evidence Team (IET) through LCM; build high performance multifunctional team.
- Responsible for overall assessment of benefit/risk, Go/No-go criteria, and Clinical PoS for the medicine development recommendations from C2P through launch
- Single China IET/TMT voice at the program level into China-DRB, China PIB, MDT, EDT, Medical, and Commercial
- Lead China disease area strategy development to inform portfolio prioritisation & delivery
- Lead interactions and positively interface with a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) to deliver integrated medicine strategy, drive innovation and advance science and practice
- Develop Clinical strategy and development plan for the assets/indications in China
- Resource, build and develop high performance Clinical /TA team
- Lead trial design and protocol development for local registration, PAC and other Ph4 studies; input to global clinical programs with China participation
- Lead scientific components of, and provide strategic inputs to regulatory interactions
- Oversee the overall, and lead for Clinical, the end-to-end delivery of clinical studies in alignment with IEP and meeting quality, budget and timeline requirements
- Responsible for (physician) or ensuring (scientist) medical governance of the project
- Create innovative scientific and technical solutions to accelerate clinical development including use of digital tools, technology applications, analytical methodology/modelling, mechanistic strategy
- MD, PhD or PharmD degree with > 5 years of experience in medical practice and/or scientific research in the relevant field.
- >10 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
- Significant experience in clinical trial conception, design, planning, operationalisation, reporting, data analysis and publication
- Thorough 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
- Strong 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, complexity management, multidisciplinary collaboration, operating at pace and agile decision making
- Experience in appropriately resourcing, and line management /matrix leadership
- Success in building high performance team by inspiring, motivating, coaching, mentoring
- Outstanding ability to communicate effectively with credibility, accuracy, and confidence with internal and external stakeholders
- Proficiency in English
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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