A Team Eager to Excel & Make an Impact

20+ years of international CRO management and operational experience.

A top international executives in the industry, supervised 600-800 clinical trials annually, led a global clinical team of 5,700+ professionals across 55 countries.

Broad experience in cross-regional mergers, personnel and business development.

Conducted due diligence on biotech/medical device companies, and serves as aboard member for a global biotech company.

MD PhD in medicine and surgery, 20+ years of experience in industry and clinical setting.

Expertise in Drug Development, Regulatory Strategy and Medical Sciences/MW/PV, leading to successful IND/NDA/MAA worldwide.

15 years of experience in multinational pharmaceutical companies and CROs, cross-functional leadership skills in diverse therapeutic areas (phases I-IV and IIT studies).

Extensive knowledge in global and Greater China regulatory affairs.

Over 17 years of commercial leadership experience across multiple regions, including key senior roles at leading CROs.

Strong background in building, scaling, and transforming emerging organizations into recognized industry leaders.

Deep understanding of the key challenges faced by biotech companies, especially in accelerating timelines, reaching critical milestones, advancing innovative therapies, and maximizing patient impact.

Over 30 years of experience in the pharmaceutical and clinical research industry.

With 21 years of experience at three international pharmaceutical companies, held key roles in drug development, project management, clinical research, pre-clinical studies, and regulatory affairs.

Another 12 years of experience at two global CROs, overseeing client relationship development, clinical operations, and FSP/Dispatch business.

20+ years of project management and operations experience, serving top-tierinternational CROs.

Managed 200+ project managers and clinical operations professionals across 26 countries, including the US, Latin America, Europe, and Asia.

Served as a strategic consultant for 35 key clients, and completed 110+ projects, assisting in the expansion of the company’s overseas business in Asia, including Japan.

12+ years of experience in quality management and data operations in the fields of CRO and pharmacutical.

Extensive expertise in establishing quality management systems, process optimization, and overseeing audits/inspections.

Supervised, co-audited, and provided support for 30 inspections and internal/external audits in the US, EU, and APAC.

Results-oriented and strategic minded individual with more than 20 years of experience in clinical research across APAC, EMEA, LATAM and US.

Proven track record in overseeing clinical deliverables, driving process improvements with physical operational experiences in Australia, Mainland China, Taiwan and Ireland.

Experienced Head of Clinical Affairs and Operations Globally with a demonstrated history of working in In-vitro diagnostic, CRO and pharmaceuticals industry.

20+ years of experience in pharmaceutical companies, global CROs, and venture capital, covering regulatory consulting, strategy, planning, execution, post-investment management and due diligence.

17+ years of regulatory affairs experience in APAC, managing teams of 55 members in Mainland China, Taiwan, Korea, Malaysia, the Philippines, and  Thailand.

Responsibilities include providing regulatory consultancy and managing submissions for clinical and drug registrations in APAC.

Over 13 years of experience in the global pharmaceutical and CRO industry.

Extensive expertise in regulatory operations, including NDA submissions, IND submissions, GMP inspections, gap analysis, and more.

Has a remarkable career record of leading regulatory teams, overseeing start-up operations, and achieving significant milestones in regulatory approvals, including securing Top 3 rankings in Korea’s HA (MFDS) IND Approvals on multiple occasions, including in 2023.

Over 30 years’ experience within multi-national pharmaceutical and CRO industries, with a holistic understanding of all aspects of drug development.

Grown PharmaSols to be an extremely successful Australia and New Zealand focused CRO.

Successfully operated full-service clinical institutions from phase I to IV in the local area, covering cardiovascular, oncology, blood diseases, endocrine, respiratory and neurological diseases.

23 years of industry experience across CRO, biotech, and site perspectives, with a strong focus on building high-performing teams and departments while consistently meeting high-quality standards expected by clients.

Extensive expertise collaborating with biotech clients, understanding their unique needs, and supporting their efforts to achieve corporate milestones and accelerate project timelines.

Proven management experience spanning clinical operations, project management, and biometrics, ensuring efficient and seamless project delivery.

Over 30 years of clinical trial management experience in pharma and niche CRO; over 25 years in oncology product development.

Experienced with compiling IND and NDA submissions for FDA.

Initiated and executed international phase 1-4 trials for oncology therapeutics.

15 years in the clinical research industry with varied experience in Clinical Operations, Training and Compliance, Quality Assurance, Project Management and Monitoring experience in Europe and APAC Countries.

Experience on several therapeutics’ areas such as Oncology, Psychiatry, Endocrinology, Infectious Diseases, Endocrinology, Rheumatology, Medical Device and Vaccines.

Former President of Philippine Clinical Research Professionals (PCRP) (2021-2023).

18 years of clinical operations andmanagement experience in global CROs andpharmaceutical companies.

Former head of clinical startup departmentin a multinational CRO, overseeing 100+ staff in Greater China, Korea, the Philippines, Thailand, and other APAC countries.

Comprehensive experience in project and clinical operations management; strong focus on progress and quality control.

18 years of data science operational and management experience in top-tier global CROs.

Led teams of 90+ professionals in clinical data operations, medical coding, and clinical data programming, supporting 150+ clinical studies.

Dedicated to solutions in data statistics services, process automation, and data visualization.