Local Delivery Lead (RWE) at GSK in Tokyo, Tokyo, Japan

Local Delivery Lead (RWE) Location: Japan - Tokyo - Akasaka 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 Position Summary You will lead delivery of real-world evidence (RWE) studies in Japan. You will work closely with global study teams, local colleagues, vendors and clinical sites to ensure studies run on time, on budget and to high quality. We value clear communicators who make practical decisions, build trust and coach others. This role offers visible leadership, growth in clinical operations and a chance to make meaningful impact while uniting science, technology and talent to get ahead of disease together. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: - Act as the operational lead for assigned RWE studies in Japan and drive end-to-end delivery. - Lead local start-up activities including feasibility, site selection and regulatory and ethics submissions. - Manage relationships and performance of vendors, contract research organizations and study sites. - Track local timelines, budgets and risks, and take prompt corrective actions to keep studies on track. - Maintain study documentation and ensure inspection and audit readiness for Japan activities. - Communicate study status, risks and decisions clearly to global and local stakeholders. Responsibilities - Serve as the main operational contact between central study teams and Japan-based stakeholders. - Plan and deliver local enrolment strategies and operational solutions to support recruitment goals. - Monitor study metrics, identify operational risks and drive root cause actions. - Oversee local study-level financials and support budget and contract discussions with sites and vendors. - Ensure local activities follow Good Clinical Practice, ICH guidance and Japanese regulatory requirements. - Coach and support local study staff and promote practical process improvements. Why You? Work model: This role is hybrid with regular on-site presence expected in Japan. Travel within Japan and occasional international travel may be required. Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals: - Bachelor’s degree in life sciences, pharmacy, nursing, clinical research or a related field. - At least 5 years’ experience in clinical operations, study management or related roles. - Practical experience managing CROs, vendors or external partners for study delivery. - Strong knowledge of GCP, ICH guidelines and Japanese regulatory and ethics submission processes. - Clear stakeholder management and collaboration skills across functions and organisations. - Fluency in Japanese and professional working proficiency in English. Preferred Qualification If you have the following characteristics, it would be a plus: - Advanced degree in life sciences, clinical research, pharmacy or related discipline. - Experience leading multi-site or multi-country RWE or clinical studies based in Japan. - Proven track record of meeting recruitment targets and managing study-level budgets. - Familiarity with electronic trial master file systems and common clinical operations tools. - Experience supporting inspections, audits or corrective action plans. - Project management certification or formal clinical operations training. Apply now If this role speaks to you, please submit your CV and a brief cover note. Tell us why this role matters to you and how your experience fits. We look forward to hearing from you and exploring how you can progress your career while helping us get ahead of disease together. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. We are committed to creating an inclusive workplace and providing equal opportunities for all applicants. We embrace an agile working culture across our roles, so if flexibility is important to you please discuss opportunities with our hiring team. If you need any adjustments to the recruitment process to help you demonstrate your strengths and capabilities, contact APACRecruitment.Adjustments@gsk.com. Please note this email is for adjustment requests only; for other enquiries please use our standard contact channels. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. 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