Precision Medicine is an organization within Development which aims to drive end-to-end clinical development of innovative medicines and vaccines with clinical pharmacology, model-informed drug and vaccine development, biomarker and diagnostic strategies, state-of-the-art bioanalysis capabilities, to transform clinical care and drive meaningful patient outcomes. Through this we inform the clinical development of the right medicine or vaccine at the right dose (regimen) at the right time for the right patient supported with the right assays.
Does this mission excite you? If so, GSK Asia Development is evolving to address specific demands and growth opportunities in Asia, especially in China and Japan, by focusing on both regional challenges and potential to strengthen GSK’s influence. The strategy centres on three priorities:
- Execution: Accelerate delivery of Innovative Medicines and Vaccines in Asia, by impactful contribution to co-creation of strategy and execution, actively shaping the ecosystem in China and Japan.
- Technology: Drive innovation and tech advancements in Asia and beyond, by enabling business development and harnessing cutting-edge digital tools and tech
- Culture: Foster culture of inclusivity and collaboration and nurture both Asian and next-gen global leaders to ensure they thrive
What we are looking for
We are seeking a dynamic and highly skilled leader to serve as the Head of Precision Medicine Asia who will report to the Head of Asia Development with a dotted line to Global Head of Precision Medicine. This role is responsible for driving the overall Precision Medicine strategy in the Asia region with specific focus on leveraging innovative clinical pharmacology and MIDD approaches, while integrating with comprehensive biomarker and diagnostic solutions to directly impact drug development programs in the Asia region. The successful candidate will manage a multidisciplinary team of experts, collaborating across global and regional functions to deliver innovative, personalised healthcare solutions that enhance patient outcomes.
Key responsibilities:
Strategic Leadership:
- Represents Precision Medicine organization on the Asia development leadership team and ensures full integration of the Precision Medicine strategy within the overall Asia development plans.
- Develop and implement Precision Medicine strategies specific to the Asian population while aligning with the global objectives.
- Lead clinical pharmacology and bioanalytical operational and regulatory strategies with respect to Chinese and Japanese authorities with a vision to expand to other countries in the region
- Identify opportunities to integrate clinical pharmacology, MIDD, and biomarker and diagnostic capabilities into Asia development efforts to personalise treatments for the Asian population.
- Ensures unified vision, strategy, goals, ways of working and communications across regional and global Precision Medicine teams.
- Approval of design, analysis, interpretation, reporting and corresponding regulatory documents across a portfolio of programs
Team Management and Development:
- Lead and manage a multidisciplinary team specialising in clinical pharmacology, biomarkers, bioanalytical, and diagnostic capabilities.
- Foster a high-performing, collaborative team environment, driving innovation and professional growth.
- Contribute to group's awareness of the emerging regional and global key scientific and technical innovations to help drive our continuous improvement.
- Maintain strong working relationships with the global functions within the Precision Medicine organization and with the regional cross-functional Asia development team.
Clinical Pharmacology Expertise:
- Oversee the application of clinical pharmacology and MIDD principles (e.g. Phase 1 strategy, clinical pharmacology plan, PKPD and QSP modelling) to support Asia development plans.
- Ensure optimal dose selection and therapeutic strategies through data-driven and model-based approaches.
- In close alignment with global clinical pharmacology strategies, oversee the clinical pharmacology components of all regulatory documents and responses such that GSK products are rapidly and efficiently approved with optimum labelling.
- Work with local and global experts to design and implement optimized MIDD strategies
Biomarker and Diagnostics Integration:
- In collaboration with global clinical biomarker team, oversee biomarker discovery, validation, and implementation to support patient selection and monitoring strategies in Asia development.
- Oversee the writing and editing of the relevant biomarker sections of the clinical protocol, study procedural manuals and consent forms.
- Collaborate on the development and integration of diagnostics into clinical development programs.
- Work with local testing partners and health and regulatory authorities to enable development, testing, validation, and registration of diagnostics as needed per the Asia development asset plan.
Cross-functional Collaboration:
- Work closely with internal and external stakeholders, including development, biostatistics, regulatory, and commercial teams, to ensure Precision Medicine strategies are effectively executed in Asia.
- Partner with regulatory authorities in Asia to ensure compliance with Precision Medicine requirements.
- Drive partnership sourcing and evaluation by enabling appropriate selection of capable partners to allow tech / innovation capture
Basic Qualifications:
- PhD or equivalent in clinical pharmacology, pharmacokinetics, biopharmaceutics, or other relevant discipline
- 10 years of experience in designing global clinical pharmacology plans and in the application of MIDD approaches in drug development within the pharmaceutical industry.
- Experience in basics of bioanalytical and biomarker assay development and application in drug development
- Minimum of 10 year experience in Clinical Pharmacology in an industry setting with different components of a precision medicine strategy.
- Direct experience with regulatory interactions (e.g. IND, NDA/BLA, response to questions) with respect to both Japan and China
Preferred Qualifications:
- Specific experience in the integration of biomarker strategies into the MIDD and clinical development plans.
- Prior experience in development, testing, and registration of diagnostic tests.
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:
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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