Clinical Research
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Jobs in Clinical Research.
Associate Director Regulatory Operations (Japan)
- Attractive Salary & Benefits Package
Benefits • Senior leadership opportunity in a Japan market build phase • Strategic influence on regulatory positioning in Japan • Competitive base salary with bonus structure • Flexible working arrangement, remote initially • Opportunity to shape and build a future team About the Company Our client is a global clinical research organisation supporting biotechnology and pharmaceutical companies with the design and delivery of clinical trials across multiple regions. With established operations internationally, the organisation is now strengthening its direct presence in Japan as part of its continued global expansion. About the Opportunity This is a senior regulatory leadership role responsible for establishing and overseeing regulatory operations capability within Japan. Reporting directly to the Japan Country Head, the Associate Director will provide strategic regulatory oversight across ongoing and future clinical trials. The role will focus on regulatory deliverables within Japan, ensuring compliance with PMDA and local requirements while supporting business growth initiatives. The successful candidate will act as a senior regulatory advisor to internal stakeholders and clients, contributing to feasibility assessments, bid defence activities and strategic planning. Initially this role will operate as an individual contributor, with the expectation of building and leading a regulatory team as Japan operations expand. This is a pivotal appointment in strengthening the organisation’s long-term presence in Japan. Duties Provide strategic oversight of regulatory operations in Japan Oversee preparation and review of regulatory submissions Act as Japan regulatory subject matter expert Advise internal teams on regulatory strategy and timelines Support business development and bid defence activities Build scalable regulatory processes and frameworks Collaborate closely with global clinical and project teams Represent regulatory function in leadership discussions Skills and Experience CRO regulatory operations background Strategic and commercial regulatory capabilities PMDA submission expertise Leadership experience Fluent Japanese and English Life sciences degree Culture Fast-paced, growth-oriented and collaborative. A build-phase environment where senior leaders work closely together to shape the future direction of the Japan business. How to Apply Click apply or contact Adrian McConchie, Director Executive Search at amcconchie@hpgconnect.com in confidence. About Healthcare Professionals Group Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care. • Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific; • Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs; • Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse; • Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing. For more job opportunities, visit www.hpgconnect.com.
Senior Manager, Clinical Operations (Japan)
- Attractive Salary & Benefits Package
Benefits Senior leadership role within expanding Japan operations Direct collaboration with Japan Country Head Competitive salary and bonus structure Flexible working arrangement Opportunity to build and lead future clinical team About the Company Our client is a global clinical research organisation delivering end-to-end clinical trial solutions to biotech and pharmaceutical sponsors worldwide. As part of strengthening its Japan presence, the organisation is expanding its internal clinical operations capability. About the Opportunity The Senior Manager, Clinical Operations will oversee clinical trial delivery within Japan, ensuring compliance with ICH-GCP, local regulations and company SOPs. Reporting to the Japan Country Head, this role will provide leadership across clinical operations while maintaining close collaboration with project management and regulatory teams. Initially this position will operate as an individual contributor role with billable responsibilities, with scope to transition into broader team leadership as the Japan structure expands. The role will support current and future studies in Japan, working within a global matrix environment. Duties Oversee local clinical trial execution Support and guide monitoring activities Collaborate with project management teams Ensure regulatory and SOP compliance Contribute to training and development Participate in client meetings as required Identify process improvement opportunities Skills and Experience CRO clinical operations experience Prior CRA experience Line management experience Fluent Japanese and English Life sciences degree Culture Performance-driven, collaborative and internationally connected. A hands-on leadership environment in an expanding Japan business. How to Apply Click apply or contact Adrian McConchie, Director Life Sciences Executive Search at amcconchie@hpgconnect.com in confidence. About Healthcare Professionals Group Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care. Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific; Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs; Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse; Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing. For more job opportunities, visit www.hpgconnect.com.
Senior Clinical Project Manager
- Competitive
Benefits Senior project leadership within growing Japan operations Direct exposure to global sponsors and executive stakeholders Competitive base salary with performance bonus structure Opportunity to expand scope across APAC and global programs About the Company Join a global Contract Research Organisation (CRO) supporting pharmaceutical and biotechnology companies with the planning and execution of clinical trials worldwide. With a strong international presence and expanding regional footprint, the organisation is investing in strengthening its direct Japan capability to support continued growth across APAC. The Japan business plays a strategic role within the global framework, offering the opportunity to work on complex, high-profile studies while contributing to the development of local operational excellence. About the Opportunity The Senior Clinical Project Manager will lead the end-to-end planning and execution of clinical trials within Japan, acting as the primary contact between the organisation and sponsors Project Manager. You will be accountable for study delivery from site selection through to close-out, ensuring projects are delivered on time, within budget, and in compliance with ICH-GCP and local regulatory requirements. This role requires strong operational oversight, financial management capability, and the ability to lead cross-functional project teams across Clinical, Regulatory, Biometrics, and external vendors. Initially focused on Japan-based studies, the position offers future scope to expand into APAC and broader global projects, providing exposure to complex, multi-regional programs and senior stakeholder engagement. Duties Lead full lifecycle clinical project delivery from feasibility and start-up through to database lock and close-out Act as primary client contact, managing sponsor communication and expectations Coordinate cross-functional internal teams to ensure aligned and compliant project execution Manage change orders in collaboration with Business Development to ensure scope adjustments are appropriately documented and approved Drive subject recruitment strategy and site performance management to meet study timelines Contribute to bid defence meetings and support feasibility and business development activities Skills and Experience Extensive CRO project management experience is essential Minimum 5 years’ experience within the clinical research industry, including prior Project Management responsibility Project Manager Prior CRA background with strong understanding of site management and monitoring activities Strong knowledge of ICH-GCP and Japan regulatory requirements Fluent Japanese (native-level proficiency) and business-level English communication skills are required Tertiary qualification in life sciences or a related discipline Demonstrated ability to lead cross-functional teams within a matrixed global environment Culture Dynamic, accountable, and highly collaborative. The Japan operation is in a growth phase, offering strong leadership visibility and the opportunity to shape local delivery capability while backed by established global infrastructure and systems. How to Apply Click apply or contact Rohan Lallbeeharry - Senior Recruitment Consultant - via email at rlallbeeharry@hpgconnect.com or call +61 485 860 660 for a confidential discussion. About Healthcare Professionals Group Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care. Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific; Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs; Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse; Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing. For more job opportunities, visit www.hpgconnect.com.
Senior Manager, Regulatory Affairs Operations
- Competitive
Benefits Attractive salary package with performance bonus Flexible working model to support a balanced lifestyle High-visibility role working directly with Japan Country Head Ongoing opportunities for career progression into formal team leadership About the Company Join a market-leading global Contract Research Organisation (CRO) partnering with biotechnology and pharmaceutical companies to deliver high-quality clinical trials worldwide. With a strong international footprint and continued investment across APAC, the organisation is expanding its direct regulatory capability in Japan. The Japan business represents a key strategic growth market, supported by global infrastructure and leadership. This is an opportunity to join a high-performing CRO environment where regulatory expertise is central to operational excellence and client delivery. About the Opportunity The Senior Manager, Regulatory Affairs Operations will oversee regulatory deliverables across clinical trials within Japan, ensuring full compliance with ICH-GCP guidelines and local regulatory requirements. Reporting directly to the Japan Country Head, you will provide operational regulatory leadership while working closely with Project Management and Clinical Operations teams. You will be responsible for managing regulatory submissions, documentation, and start-up activities to ensure timely approvals and high-quality execution. Duties Lead and manage regulatory submission deliverables (RA and EC) to ensure timely clinical trial approvals Review and approve regulatory documentation to ensure compliance with ICH-GCP and local regulations Act as key liaison with regulatory authorities and ethics committees as required Contribute to process optimisation and continuous improvement initiatives within regulatory operations Support bid preparation and provide regulatory input into business development activities Collaborate with global stakeholders to ensure alignment with international standards and delivery models Skills and Experience Current or prior CRO regulatory experience is essential Strong knowledge of Japan regulatory requirements and clinical trial start-up processes Minimum two years’ line management experience is essential, or demonstrated readiness to step into formal team leadership At least 5 years’ experience within the pharmaceutical or clinical research industry Fluent Japanese (native-level proficiency) and business-level English communication skills are required Culture Join a collaborative, quality-focused, and commercially aware organisation with strong global backing. The Japan operation is in an exciting growth phase, offering high visibility, direct leadership engagement, and the opportunity to shape regulatory capability locally while contributing to global standards of excellence. How to Apply Click apply or contact Rohan Lallbeeharry – Senior Recruitment Consultant – at rlallbeeharry@hpgconnect.com or call +61 485 860 660 for a confidential discussion. About Healthcare Professionals Group Healthcare Professionals Group recruits all positions: Medical Affairs & Life Sciences Recruitment: Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific. Commercial Recruitment: Marketing, Sales, Analytics, Government, and External Affairs. Business Operations & Infrastructure Recruitment: Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse. Clinical Care Recruitment: Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing.
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