c-shape
ABOUT

Leadership

Linical's commitment to providing quality services starts with our people. Our team members are passionate about their work and are dedicated to fulfilling each client's requirements in a timely, accurate, well managed and cost-effective manner.

Our Leadership Across the Globe

Americas & Europe Leadership Team

Isao Sakamoto, Ph.D.

Chief Executive Officer

Isao Sakamoto, Ph.D.

Chief Executive Officer
  • Established Linical in 2005 as one of the co-founders
  • Leads the Linical Group as one of the HQs' Board members (since 2007), Linical Americas organization (2018 to 2020 and 2023 - ), Linical Europe organization (2021 to 2022), ensuring commitment to and compliance with all applicable laws and regulations across the organization as well as contributing global operations with close and timely communications with HQs and the other affiliates
  • Ph.D. of Medicine from Kobe University and Master of Science, Pharmaceutical Sciences from Tokyo University of Pharmacy and Life Sciences

Tracy Goeken, M.D.

Chief Medical Officer

Tracy Goeken, M.D.

Chief Medical Officer
  • Accomplished Medical Doctor with extensive experience as an Executive and Chief Medical Officer in the Clinical Development and Medical Affairs functions with experience in multiple therapeutic areas across drug/biologic and medical device platforms, including oncology and endothelial cell injury and dysfunction within cardiac, multi-organ transplant and vascular indications
  • Responsible for providing strategic and operational leadership regarding the company's Medical and Scientific Operations
  • Prior to joining Linical, was Chief Medical Officer at a Global Biotech Company and held positions as VP of Clinical and Medical Affairs as well as Director, Global PV
  • Received his MD from St. Christopher’s College of Medicine in Luton, England, and completed his clinical training at LSU Health Sciences Center in Houma, Louisiana

Clareece West

Chief Commercial Officer

Clareece West

Chief Commercial Officer
  • Over 20 years of executive leadership experience including global clinical and commercial operations across numerous therapeutic areas, regulatory, data management, safety, change management, international sales, proposals and marketing, M&A, P&L, and restructuring expertise
  • Proven global commercial leader who has worked in global leadership positions across health technology, two Fortune Top 10 companies, and large CROs
  • Served the American Red Cross, GKCNWMO board, Vice President of the Healthcare Businesswomen Association Board of Directors (KC Region) and Founding Member of the Women’s Capital Connection, a regional angel investment group and continues to serve as an active Board member

Will Kiser, CPA

Chief Financial Officer

Will Kiser, CPA

Chief Financial Officer
  • Oversees corporate accounting, financial reporting and budgeting, audit compliance, and the financial delivery of Linical America’s clinical trials
  • Certified Public Accountant with 16 years of financial experience within the CRO industry
  • Prior to joining Linical Americas in 2021, held varied roles of increasingly visibility and responsibility at a globally recognized CRO which provided extensive exposure to the many unique challenges CRO’s face today
  • Earlier in his career, served as the Financial Controller for a manufacturing firm for several years
  • Holds a degree in Accounting from Appalachian State University

Miguel Urrutia

Chief Information Security Officer

Miguel Urrutia

Chief Information Security Officer
  • Technology and certified information security professional (CISSP) with over 14 years of practical experience in enhancing IT operations, and security programs, building and leading successful teams
  • Previously worked as Global Information Technology Director, successfully leading IT operations supporting global mergers and acquisitions, managing cross-functional teams, overseeing the global IT infrastructure, and supporting over 1,200 end users across the globe
  • Holds a Master in Information Technology specializing in security management from Colorado Technical University  & currently attending Texas A&M pursuing a second Master of Legal Studies specializing in Cybersecurity Law

Tyler Cochran

Chief Compliance Officer

Tyler Cochran

Chief Compliance Officer
  • Over 20 years of experience in the Life Sciences, including pharmaceuticals, biologics and medical devices
  • Global leadership experience in the areas of Quality, Compliance, Enterprise Risk Management, Regulatory Affairs, Pharmacovigilance and Clinical Development
  • Holds a BS in Biological Sciences from Kennesaw State University and a Master of Science in Jurisprudence from Seton Hall University School of Law

Heidi Miller

Senior Vice President of Clinical Operations

Heidi Miller

Senior Vice President of Clinical Operations
  • Oversees and manages the Project Management and Clinical Operations departments of North America and Europe.
  • Leverages 30 years of clinical research experience to provide leadership to ensure operational excellence, client satisfaction, and financial performance.
  • In prior role as Senior Project Director at Linical, providing oversight and management of global and regional teams for phase I-III clinical trials
  • Therapeutic expertise includes oncology, neurology, endocrinology, infectious disease, and ophthalmology
  • Extensive experience overseeing teams working on rescue studies (regional and global)
  • Prior to joining Linical, held positions as Senior Project Manager, Clinical Research Manager, Safety Compliance Manager, Senior Clinical Research Associate and Nurse
  • Bachelor of Science in Nursing from the University of Ottawa
  • Practiced nursing in General Medicine, General Surgery, Surgical Intensive and Trauma Care, Community Nursing and Clinical Research

 

Marisol Ribes

Vice President, Human Resources

Marisol Ribes

Vice President, Human Resources
  • More than 15 years experience leading human resources in international companies in fields including life science, automotive supply chain and renewable energy
  • Areas of expertise include, employment law, C&B,  organizational development and  talent management
  • Extensive experience in M&A due diligence and post-merger integrations  
  • Degree in law, HR management and master´s degree in global reward management 
  • Active member of several professional HR organizations, including the German Human Resource Management association (BPM)

Isao Sakamoto, Ph.D.

Chief Executive Officer
  • Established Linical in 2005 as one of the co-founders
  • Leads the Linical Group as one of the HQs' Board members (since 2007), Linical Americas organization (2018 to 2020 and 2023 - ), Linical Europe organization (2021 to 2022), ensuring commitment to and compliance with all applicable laws and regulations across the organization as well as contributing global operations with close and timely communications with HQs and the other affiliates
  • Ph.D. of Medicine from Kobe University and Master of Science, Pharmaceutical Sciences from Tokyo University of Pharmacy and Life Sciences

Tracy Goeken, M.D.

Chief Medical Officer
  • Accomplished Medical Doctor with extensive experience as an Executive and Chief Medical Officer in the Clinical Development and Medical Affairs functions with experience in multiple therapeutic areas across drug/biologic and medical device platforms, including oncology and endothelial cell injury and dysfunction within cardiac, multi-organ transplant and vascular indications
  • Responsible for providing strategic and operational leadership regarding the company's Medical and Scientific Operations
  • Prior to joining Linical, was Chief Medical Officer at a Global Biotech Company and held positions as VP of Clinical and Medical Affairs as well as Director, Global PV
  • Received his MD from St. Christopher’s College of Medicine in Luton, England, and completed his clinical training at LSU Health Sciences Center in Houma, Louisiana

Clareece West

Chief Commercial Officer
  • Over 20 years of executive leadership experience including global clinical and commercial operations across numerous therapeutic areas, regulatory, data management, safety, change management, international sales, proposals and marketing, M&A, P&L, and restructuring expertise
  • Proven global commercial leader who has worked in global leadership positions across health technology, two Fortune Top 10 companies, and large CROs
  • Served the American Red Cross, GKCNWMO board, Vice President of the Healthcare Businesswomen Association Board of Directors (KC Region) and Founding Member of the Women’s Capital Connection, a regional angel investment group and continues to serve as an active Board member

Will Kiser, CPA

Chief Financial Officer
  • Oversees corporate accounting, financial reporting and budgeting, audit compliance, and the financial delivery of Linical America’s clinical trials
  • Certified Public Accountant with 16 years of financial experience within the CRO industry
  • Prior to joining Linical Americas in 2021, held varied roles of increasingly visibility and responsibility at a globally recognized CRO which provided extensive exposure to the many unique challenges CRO’s face today
  • Earlier in his career, served as the Financial Controller for a manufacturing firm for several years
  • Holds a degree in Accounting from Appalachian State University

Miguel Urrutia

Chief Information Security Officer
  • Technology and certified information security professional (CISSP) with over 14 years of practical experience in enhancing IT operations, and security programs, building and leading successful teams
  • Previously worked as Global Information Technology Director, successfully leading IT operations supporting global mergers and acquisitions, managing cross-functional teams, overseeing the global IT infrastructure, and supporting over 1,200 end users across the globe
  • Holds a Master in Information Technology specializing in security management from Colorado Technical University  & currently attending Texas A&M pursuing a second Master of Legal Studies specializing in Cybersecurity Law

Tyler Cochran

Chief Compliance Officer
  • Over 20 years of experience in the Life Sciences, including pharmaceuticals, biologics and medical devices
  • Global leadership experience in the areas of Quality, Compliance, Enterprise Risk Management, Regulatory Affairs, Pharmacovigilance and Clinical Development
  • Holds a BS in Biological Sciences from Kennesaw State University and a Master of Science in Jurisprudence from Seton Hall University School of Law

Heidi Miller

Senior Vice President of Clinical Operations
  • Oversees and manages the Project Management and Clinical Operations departments of North America and Europe.
  • Leverages 30 years of clinical research experience to provide leadership to ensure operational excellence, client satisfaction, and financial performance.
  • In prior role as Senior Project Director at Linical, providing oversight and management of global and regional teams for phase I-III clinical trials
  • Therapeutic expertise includes oncology, neurology, endocrinology, infectious disease, and ophthalmology
  • Extensive experience overseeing teams working on rescue studies (regional and global)
  • Prior to joining Linical, held positions as Senior Project Manager, Clinical Research Manager, Safety Compliance Manager, Senior Clinical Research Associate and Nurse
  • Bachelor of Science in Nursing from the University of Ottawa
  • Practiced nursing in General Medicine, General Surgery, Surgical Intensive and Trauma Care, Community Nursing and Clinical Research

 

Marisol Ribes

Vice President, Human Resources
  • More than 15 years experience leading human resources in international companies in fields including life science, automotive supply chain and renewable energy
  • Areas of expertise include, employment law, C&B,  organizational development and  talent management
  • Extensive experience in M&A due diligence and post-merger integrations  
  • Degree in law, HR management and master´s degree in global reward management 
  • Active member of several professional HR organizations, including the German Human Resource Management association (BPM)

Asia Pacific Leadership Team

Toshiaki Nagafuji Ph.D.

Senior Executive Officer, Head of Innovative Drug Development Business Unit, Linical Japan

Toshiaki Nagafuji Ph.D.

Senior Executive Officer, Head of Innovative Drug Development Business Unit, Linical Japan
  • +30 years of experience in the pharmaceutical and CRO industry in Japan and the US.
  • +6 years of experience at Linical Co., Ltd. (Osaka, Japan) in leading IDDB and providing +30 mid-sized pharma and biotech companies with the following services: market/gap analysis, medical writing, regulatory, PMDA consultation, CTN, ICCC, NDA, and strategic partnering/licensing.
  • 8 years of experience with licensing/business development and corporate planning at Shionogi & Co. and made 5 licenses and 1 M&A deals.
  • 7 years of experience with clinical monitoring, project management and regulatory strategy for the products to treat brain diseases at Shionogi & Co. and its subsidiary in NJ, USA.
  • 13 years of experience with drug discovery & neuroscience research at Chugai Pharmaceuticals, Visiting Researcher at Departments of Neurology and Neurological Surgery, University of California at San Francisco, USA and Visiting Professor at Department of Molecular Neuropathology, Brain Research Institute, Niigata University, Japan.
  • Ph.D. (Pharmaceutical Sciences) from Hiroshima University

Kosuke Yoshida

Senior Director, Contract Medical Affairs Unit, Linical Japan

Kosuke Yoshida

Senior Director, Contract Medical Affairs Unit, Linical Japan
  • More than 10 years of experience in quality control of clinical trials at Astellas Pharma, including global SOP manager,  system administrator, and global trainer.
  • At Linical, experience as a head of the QC2 and CMA departments, and experience in setting up a large clinical study of colorectal cancer and an Asian clinical study of rheumatoid arthritis.
  • An established member of the Japan Society of the Clinical Trials and Researches (JSCTR), which was established in 2009, and a board member and a leader of the Seminar Planning and Conducting Team of JSCTR, also now.
  • A leader of the Pocket's Reference Book for the multi-regional clinical study and the clinical trial in Japan.
  • Holds a Master of Science degree.

Satoru Toyota

Senior Executive Officer, Head of Oncology Business Unit, Linical Japan

Satoru Toyota

Senior Executive Officer, Head of Oncology Business Unit, Linical Japan
  • Over 28 years working in the pharmaceutical industry including CRO and his career is mainly focusing on oncology field
  • Over 12 years working at Linical Japan HQs, in heading Oncology area and managing and oversighting over 70 studies through Phase I-IV
  • Last 8 years responsible for Senior Executive Officer in Linical Japan HQs
  • Extensive experience in clinical research & development, sales, marketing and CRO business 
  • Holds a Bachelor of Osaka University of Pharmaceutical Sciences (Osaka Medical and Pharmaceutical University) and holds a national qualification of the pharmacist license
  • Holds a certificate of PASSPORT for GOOD CLINICAL PRACTICE from Japan Society of Clinical Trials and Research
  • Holds a certificate Shogi 5th Dan of Japan Shogi Association

Tomoko Inomata

Senior Executive Officer, Head of Primary Business Unit, Linical Japan

Tomoko Inomata

Senior Executive Officer, Head of Primary Business Unit, Linical Japan
  • Over 20 years of experience in the pharmaceutical and CRO industry, including management of Phase I-III clinical studies
  • Extensive experience in a variety of therapeutic areas including Ophthalmology, Respiratory, Immunology, Neurology, Pain, etc.
  • She started her career as a CRA at a global pharmaceutical company then worked at a Japan based pharma before joining Linical
  • Provides added value from a sponsor's perspective and strengthens relationships with sponsors
  • Holds a master of pharmacy from Hoshi University
  • Holds a Certificate of PASSPORT for GOOD CLINICAL PRACTICE from Japan Society of Clinical Trials and Research

Jihoon Hwang

President & CEO, Linical Korea

Jihoon Hwang

President & CEO, Linical Korea
  • Jihoon Hwang holds a Master’s Degree in Biological Science from Ajou University in Korea.
  • Mr. Hwang worked in the Department of Drug Development for a local Bio-pharmaceutical company, (Korea Green Cross), for 8 years.
  • From 2004, he worked for 2 CRO companies, including Linical Korea.
  • He is now a Director, who has responsibility for Business Development, Regulatory Affairs, and overall management of Linical Korea.

 

Eun Kyung An

Vice President, Linical Korea

Eun Kyung An

Vice President, Linical Korea
  • Eun Kyung An joined Linical as QA and Training Manager in 2014
  • In 2016, she became Director of Clinical Operation of Linical Korea
  • Prior to joining Linical, Ms. An held various positions across clinical operations, training and quality assurance in other CRO companies.
  • Ms. An has more than 15 years experiences in the clinical trial industry
  • Ms. An holds a Bachelor in Nursing from Yonsei University, in Wonju, Korea.

Masaya Miyazaki

Executive Vice President, Linical Japan President & CEO, Linical Taiwan Co., Ltd. President & CEO, Linical China Co., Ltd.

Masaya Miyazaki

Executive Vice President, Linical Japan President & CEO, Linical Taiwan Co., Ltd. President & CEO, Linical China Co., Ltd.
  • After graduating from the School of Pharmaceutical Sciences at Kyoto Pharmaceutical University, Mr. Miyazaki earned a Master’s degree in Pharmacology at the same university.
  • After a stint as a CRA in Japan, in 1999 he started working on the development of immunosuppressant drugs in the Development Division of Fujisawa Pharmaceutical Co., Ltd. (now Astellas Pharma Inc.).
  • From 2003, he worked as a project leader on fertility and anticancer drugs at a foreign pharmaceutical company.
  • In 2005, he co-founded Linical and on the opening of the Tokyo office in 2006 was appointed a director of the company.
  • After serving as head of the Development division, Mr. Miyazaki assumed the position of Executive Vice President, Asia and President and CEO of Taiwan in December 2020.

Toshiaki Nagafuji Ph.D.

Senior Executive Officer, Head of Innovative Drug Development Business Unit, Linical Japan
  • +30 years of experience in the pharmaceutical and CRO industry in Japan and the US.
  • +6 years of experience at Linical Co., Ltd. (Osaka, Japan) in leading IDDB and providing +30 mid-sized pharma and biotech companies with the following services: market/gap analysis, medical writing, regulatory, PMDA consultation, CTN, ICCC, NDA, and strategic partnering/licensing.
  • 8 years of experience with licensing/business development and corporate planning at Shionogi & Co. and made 5 licenses and 1 M&A deals.
  • 7 years of experience with clinical monitoring, project management and regulatory strategy for the products to treat brain diseases at Shionogi & Co. and its subsidiary in NJ, USA.
  • 13 years of experience with drug discovery & neuroscience research at Chugai Pharmaceuticals, Visiting Researcher at Departments of Neurology and Neurological Surgery, University of California at San Francisco, USA and Visiting Professor at Department of Molecular Neuropathology, Brain Research Institute, Niigata University, Japan.
  • Ph.D. (Pharmaceutical Sciences) from Hiroshima University

Kosuke Yoshida

Senior Director, Contract Medical Affairs Unit, Linical Japan
  • More than 10 years of experience in quality control of clinical trials at Astellas Pharma, including global SOP manager,  system administrator, and global trainer.
  • At Linical, experience as a head of the QC2 and CMA departments, and experience in setting up a large clinical study of colorectal cancer and an Asian clinical study of rheumatoid arthritis.
  • An established member of the Japan Society of the Clinical Trials and Researches (JSCTR), which was established in 2009, and a board member and a leader of the Seminar Planning and Conducting Team of JSCTR, also now.
  • A leader of the Pocket's Reference Book for the multi-regional clinical study and the clinical trial in Japan.
  • Holds a Master of Science degree.

Satoru Toyota

Senior Executive Officer, Head of Oncology Business Unit, Linical Japan
  • Over 28 years working in the pharmaceutical industry including CRO and his career is mainly focusing on oncology field
  • Over 12 years working at Linical Japan HQs, in heading Oncology area and managing and oversighting over 70 studies through Phase I-IV
  • Last 8 years responsible for Senior Executive Officer in Linical Japan HQs
  • Extensive experience in clinical research & development, sales, marketing and CRO business 
  • Holds a Bachelor of Osaka University of Pharmaceutical Sciences (Osaka Medical and Pharmaceutical University) and holds a national qualification of the pharmacist license
  • Holds a certificate of PASSPORT for GOOD CLINICAL PRACTICE from Japan Society of Clinical Trials and Research
  • Holds a certificate Shogi 5th Dan of Japan Shogi Association

Tomoko Inomata

Senior Executive Officer, Head of Primary Business Unit, Linical Japan
  • Over 20 years of experience in the pharmaceutical and CRO industry, including management of Phase I-III clinical studies
  • Extensive experience in a variety of therapeutic areas including Ophthalmology, Respiratory, Immunology, Neurology, Pain, etc.
  • She started her career as a CRA at a global pharmaceutical company then worked at a Japan based pharma before joining Linical
  • Provides added value from a sponsor's perspective and strengthens relationships with sponsors
  • Holds a master of pharmacy from Hoshi University
  • Holds a Certificate of PASSPORT for GOOD CLINICAL PRACTICE from Japan Society of Clinical Trials and Research

Jihoon Hwang

President & CEO, Linical Korea
  • Jihoon Hwang holds a Master’s Degree in Biological Science from Ajou University in Korea.
  • Mr. Hwang worked in the Department of Drug Development for a local Bio-pharmaceutical company, (Korea Green Cross), for 8 years.
  • From 2004, he worked for 2 CRO companies, including Linical Korea.
  • He is now a Director, who has responsibility for Business Development, Regulatory Affairs, and overall management of Linical Korea.

 

Eun Kyung An

Vice President, Linical Korea
  • Eun Kyung An joined Linical as QA and Training Manager in 2014
  • In 2016, she became Director of Clinical Operation of Linical Korea
  • Prior to joining Linical, Ms. An held various positions across clinical operations, training and quality assurance in other CRO companies.
  • Ms. An has more than 15 years experiences in the clinical trial industry
  • Ms. An holds a Bachelor in Nursing from Yonsei University, in Wonju, Korea.

Masaya Miyazaki

Executive Vice President, Linical Japan President & CEO, Linical Taiwan Co., Ltd. President & CEO, Linical China Co., Ltd.
  • After graduating from the School of Pharmaceutical Sciences at Kyoto Pharmaceutical University, Mr. Miyazaki earned a Master’s degree in Pharmacology at the same university.
  • After a stint as a CRA in Japan, in 1999 he started working on the development of immunosuppressant drugs in the Development Division of Fujisawa Pharmaceutical Co., Ltd. (now Astellas Pharma Inc.).
  • From 2003, he worked as a project leader on fertility and anticancer drugs at a foreign pharmaceutical company.
  • In 2005, he co-founded Linical and on the opening of the Tokyo office in 2006 was appointed a director of the company.
  • After serving as head of the Development division, Mr. Miyazaki assumed the position of Executive Vice President, Asia and President and CEO of Taiwan in December 2020.

Meet Linical’s Board of Directors

Learn more about the Linical’s Members of the Board.
JOIN US

Careers at Linical

To be a great place to work, we need great people to work with us. At Linical, we care deeply about employee health and wellness, financial well-being, work-life balance, professional development, and career growth. Learn more about Careers at Lincial.
“Since coming to Linical, I feel as though I have found my workplace utopia! It is so fulfilling to work in an environment with people who are truly committed to improving the lives of people through our dedication to performing top quality research”

Senior Project Manager

Successful clinical trials start with Linical.

Don’t let the complex clinical development journey hold you back. With Linical, you can overcome obstacles, save valuable time and money, and reach your goals. 

01 Request a proposal

We start by listening to your needs and understanding your goals to ensure we’re the right CRO for you.

02 Get a plan for success

We propose solutions that proactively tackle obstacles, optimize your trial design, and position you for success every step of the way.

03 Execute with confidence

We’ll guide you through each phase of the process, offering personalized support and a full range of services to help you achieve a successful trial. We are not a “one size fits all” CRO.

cta-img (2)