2018 Faculty

Karen Aitken
Associate Director of Start-Up and Regulatory
Syneos Health, Australia

Karen holds a Bachelor of Pharmacy and has held roles in clinical pharmacy and the pharmaceutical industry over 27 years. Currently, Karen is Associate Director of Site Start-Up and Regulatory at Syneos Health Australia and oversees the site activation stage of clinical trials across Australia and New Zealand. Karen advocates streamlining start-up processes and ensuring the conduct of trials in Australia and New Zealand is attractive to global sponsors.


Helen Aunedi
Country Head, Clinical Operations
Roche, Australia

Helen Aunedi has over 25 years of experience working in the pharmaceutical/healthcare industry in the Asia Pacific region, with broad leadership experience in regional and local clinical operations, development, compliance, pharmacovigilance and training. She is currently the country head of country clinical operations for Roche Pharmaceuticals Australia, providing leadership and strategic direction and oversight for all clinical trials. Helen holds a Masters of Medical Science and Drug Development from The University of NSW, Masters of Arts in Psychology from The University of Sydney and is a Six Sigma Black Belt.


Dominic Bailey
CEO
Genesis Research Services, Australia

Dom has studied Nursing, Occupational Health and Safety and Clinical Trials Research at University and is a highly experienced healthcare professional having worked extensively in both public hospitals and private companies. Dom has conducted clinical research workshops, webinars and presentations locally and internationally on Quality Management, Social Media in Clinical Trials, Medical Device Studies, and Site Development. Over 5 years he has led the development of Genesis Research Services from a small clinical trials practice into a multi-service company that manages multiple specialist investigators, international modern recruitment services, a research network, a registry of over ten thousand trial participants and obtained ongoing ISO9001 Quality Management Accreditation for all aspects of the business. With a focus on business development, innovation and sustainability, Dom’s professional goal is to provide simple and valuable quality management for clinical research success.


Carrie Bloomfield
Associate Director, Head Clinical Research, Australia & New Zealand
GlaxoSmithKline, Australia

 

Matthew Cook, PhD
Senior Clinical Site Monitor
Bristol-Myers Squibb, Australia

Matthew Cook is a Senior Clinical Site Monitor at Bristol-Myers Squibb Australia where he has worked since May 2015. Prior to this, he worked as a study coordinator on haematology, oncology, and phase I clinical studies. He has background in cell biology, working as a Research Associate/Specialist Scientist in both Australia and the United Kingdom. Matthew holds a PhD (Cell Biology), Bachelor of Science with Honours and a Graduate Certificate in Technology and Innovation Management all from the University of Queensland. Matthew has a strong focus on improving patient outcomes and on establishing strong relationships with clinical research sites.


Kelsey Dobell-Brown
Manager, Clinical Trials Support Unit
South West Sydney Local Health District (SWSLHD), Australia

Kelsey Dobell-Brown is the current Manager for the Clinical Trials Support Unit at South West Sydney Local Health District (SWSLHD). She trained and worked as an ICU (cardio-thoracic) nurse before embarking on a diverse career in clinical trials at Liverpool Hospital, the Melanoma Institute, Campbelltown Hospital and the Ingham Institute. Kelsey was instrumental in establishing the SWSLHD Clinical Trials Support Unit which includes the establishment of a clinical trials finance officer and standard operating procedures. Across the South West there are currently 25 active clinical trial groups from 19 different specialty areas. In 2016/17 the District was involved in over 300 clinical trials. She also works with researchers across the District to instill a high standard of practice through onsite Good Clinical Practice (GCP) training and in assisting researchers with the navigation through the Ethics and Governance processes. Her role also provides a point of contact for clinical trials Sponsors, Investigators and supporting departments to ensure a streamlined approach to all aspects of clinical trial feasibility, application and ongoing management.


Lorena Figueroa
CCO Line Manager, Clinical Operations
Roche, Australia

Lorena has 20 years’ experience in roles such as Global Project Manager and People Manager, both in Pharma and Biotech. She spent almost 10 years managing clinical trials at a global level. Lorena joined Roche in 2015 as a clinical research manager responsible for managing a team of regional project managers, providing functional expertise and individual coaching to support the delivery of the highest quality and standard clinical studies as well as ongoing process improvement projects. Lorena is also a member of the e-label TransCelerate APAC working group and a subject matter expert in support of the implementation of SIP and IR initiatives at Roche. Lorena holds a degree of Pharmacy from the University of Buenos Aires and a diploma in Project Management from New England University.


Steven Flaherty
Asia Pacific Head/Associate Director, Clinical Project Management, Early Clinical Development
IQVIA, Australia

 

David Fuller
Senior Vice President, Clinical Development
Syneos Health, Australia

Dr. Fuller currently holds the position of Senior Vice President, Clinical Development for Syneos Health and is qualified in both Medicine and Pharmacy. He commenced his career as a CRA for a major pharma company and now has and has over 30 years international experience including leadership of 4 product approvals. His R&D experience encompasses pre-clinical, clinical development, pharmacovigilance and medical and regulatory affairs with diverse therapeutic expertise spanning oncology, rheumatology, renal medicine, CNS, dermatology and infectious disease products. David also serves as a Board Director for Linear Clinical Research.


Mel Grand
Clinical Trials Manager, Radiation Oncology
Liverpool & Macarthur Cancer Therapy Centres, Australia

Mel is the Radiation Oncology Clinical Trials Manager at Liverpool and Campbelltown Hospitals in NSW, is employed by the Ingham Institute and has been in this position for over 3 years. Prior to this, Mel was a clinical radiation therapist and project manager of radiation oncology government-funded projects working for both TROG and RANZCR. Mel has experience with the development of investigator-initiated studies and is a current GCP trainer.


Andrew Huxley
Regional Director, Clinical Operations for Asia Pacific
Eli Lilly and Company, Australia

Andrew Huxley is currently the Regional Director of Clinical Operations for Eli Lilly within Asia Pacific. Through a number of roles Andrew has had over 5 years experience managing virtual teams and working with CROs in Asia Pacific and throughout the Emerging Markets. In this most recent role he has been responsible for leading a new functional sourcing model and organisational change which is intended to provide improved sense of partnership and customer focus. With a Bachelor of Science and MBA in Project Management and Marketing, Andrew is passionate about effectively integrating business with science. Other topics of interest include staff engagement, balanced scorecards and developing high performance teams.


Catherine Lee
Area Head, Global Clinical Site Management Asia
Pfizer, Taiwan

Catherine Lee is the Area Head of Global Clinical Site Management in Asia for Pfizer with over 24 years of experience in clinical research. Catherine is responsible for supervising the medical and operational resources in the Asia Pacific region, excluding Japan, to ensure effective delivery of key clinical site management milestones and overseeing the clinical/medical, operational and scientific oversight activities for Pfizer clinical trials. Catherine is a registered pharmacist with a Master's degree in Pharmacology and an EMBA. She is passionate about drug development and advance science with clinical research site to accelerate the availability of therapies for patients.


Marian Lieschka
Nurse Unit Manager, Cancer Clinical Trials
Peter MacCallum Hospital, Australia

 

David Lloyd
Managing Director
Southern Star Research, Australia

 

Marie Luci
Clinical Trials Contracts Manager
Cancer Trials Australia, Australia

 

Chris McConachy, BSc
Associate Director, Customer Relationship Management - Asia Pacific
Covance, New Zealand

Chris entered the clinical research industry in 2006, and subsequently joined Covance in 2011. In addition to broad experience across Clinical Operations in Asia Pacific, Chris has specific experience in the support of international clients conducting Phase I research in Australia. Chris is currently Associate Director, Customer Relationship Management for Covance in Asia Pacific - providing oversight and facilitation of customer relationships with sponsors, key research sites, and partner Institutions.


Jenny McGrath
Senior Clinical Research Coordinator
Respiratory Clinical Trials Unit, Royal Adelaide Hospital, Australia

Jenny has an extensive background in clinical research and has worked in respiratory research since 1994. As a registered nurse these qualifications compliment her research achievements (Master in Science – Research). Jenny is part of the senior management team in RCTU. Her initiatives to RCTU and the running of the Unit include: Training and education of Clinical Research Coordinators (CRC). CRC education – in ICH GCP, respiratory diseases, respiratory therapies and their uses, and study subject advocacy, Jenny developed the first business plan for RCTU (in 2003). Jenny initiates governance and finance reviews (clinical trials budget negotiations) to ensure studies undertaken are able to be completed to a high clinical research standard within given timelines.


Sophie Mepham, PhD
National Research Manager
Genesis Cancer Care, Australia

Sophie has worked in clinical research since 1997 and is currently National Research Manager for GenesisCare, specialising in research that focuses on oncology and radiotherapy treatments. Sophie previously worked as Senior Manager, Translational and Clinical Research and for 3 years as the Head of the Clinical Trials Unit at Peter Mac, covering all specialities of oncology trials, from first in human, through to phase III. Before taking up this role in Australia, Sophie worked in the UK managing a haematology clinical trials unit for 8 years and then subsequently for 2 years as a Research & Development Manager for all clinical research across a large NHS hospital as part of the National Institute for Health Research (NIHR). She is an NIHR accredited GCP trainer and GCP program lead.


Christine Pierre
President
Society for Clinical Research Sites, USA

Christine Pierre is the President of the Society for Clinical Research Sites (SCRS). She is internationally known for her expertise in clinical research site management and patient recruitment and retention for the clinical trials industry. In addition, she also addresses audiences around the world on issues pertaining to human subject protection, site operations and subject recruitment and retention. Her global reach has included presentations in Australia, Canada, Africa, Israel, and the United States.


Amy Pietrzykowski
Clinical Team Leader, Oncology Business Unit
Syneos Health, Australia

Amy Pietrzykowski is currently a Clinical Team Leader in the Oncology Business Unit of Syneos Health. She has over 17 years of experience in oncology clinical trials working in both global pharmaceutical companies and CROs. Her current role includes working within the Site ID team to identify suitable sites for new Oncology and Haematology studies in Australia and New Zealand. Amy is also the Catalyst Site Relationship Manager of the Catalyst Oncology Site Network in Australia and works within the Catalyst program to further strengthen site relationships and ensures continual process improvement and collaborative working approaches are fostered and developed to maximize efficiencies throughout the project life cycle. Amy holds a Bachelor of Science (Hons) in Pharmacology and has a keen interest in identifying and working with new sites particularly in the early phase oncology trial setting.


Megan Robertson
Director of Research
St. Vincent's Hospital Melbourne, Australia

Dr. Megan Robertson is an alumna of the University of Melbourne where she completed a Bachelor of Medicine, Bachelor of Surgery (MBBS). She is the current Director of Research at St Vincent’s Hospital, Melbourne, and works as a Senior Intensivist at Epworth HealthCare, and Assistant Censor at the College of Intensive Care Medicine (CICM). Previously, she held positions as the Director of Professional Affairs, CICM, as the Executive Director of Research at Epworth HealthCare, and as the Co-Director of the Intensive Care Unit at Epworth Freemasons.


Natasha Rogic
Regional Site Advocate
Vertex Pharmaceuticals, Australia

Natasha Rogic is a clinical research professional with over six years’ experience in the Australian and New Zealand clinical trials industry. Natasha holds a Bachelor’s degree in Science (Pharmacology) from the University of Sydney and has therapeutic experience in Cystic Fibrosis, Oncology, Haematology, Neurology, Immunology and Rare Diseases. Currently serving as Regional Site Advocate and Regional Clinical Operations Study Lead at Vertex Pharmaceuticals, Natasha has also held the roles of Site Activation Manager, Clinical Research Associate and In-House Clinical Research associate at PRA Health Sciences and AstraZeneca. Natasha has a passion for improving patient outcomes and supporting clinical research sites by removing obstacles between study sponsor and investigative sites in addition to reducing site and patient burden.


Gabriel Silver, BN, MHA
Clinical Research Associate
Medpace, Australia

Gabriel is a passionate research professional with over 13 years of experience in Clinical Trials as both a Clinical Research Coordinator and a Clinical Research Associate (CRA). Holding a Bachelor of Nursing and Master of Health Sciences (Health Administration), he has a combined 18+ years of experience in leadership positions on numerous national and international clinical research executive committees and councils. Gab is currently combining his role as a CRA with oversight of feasibility, recruitment, and site engagement operations in the Asia Pacific Region for the Global CRO Medpace.


Adam Stoneley
Clinical Trials Operations Manager
Icon Cancer Foundation, Australia

Adam is an experienced clinical operations manager with a demonstrated history of working in the hospital and healthcare industry. He is skilled in clinical research, life sciences, oncology, clinical data management, and clinical trials. He is a strong research professional with a Bachelor's degree focused in Health/Health Care Administration/Management from Queensland University of Technology.


Rick Ward
Vice President, Commercial Operations
Trifecta Clinical, USA

Rick Ward is Vice President of Commercial Operations at Trifecta - a leading global clinical technology solutions provider, producing more than 350 live, on-demand and web-based Investigator meetings each year in 87 countries. Prior to joining Trifecta, Rick has driven commercial growth strategies and led business development efforts for various CRO and niche service organizations supporting the Clinical Trial industry. Rick has over 20 years of business development experience, in both direct sales and sales management roles. Rick graduated with a degree in Marketing from the Pennsylvania State University and is a member of the Hammond Society, having served on Penn State’s Smeal College of Business Alumni Society Board of Directors from 1999 through 2013. Rick is also one of the founding members and former President of the Smeal Business Club of Philadelphia.


Angela Watt, BSc (Hons), PhD, GDHSM
Director Research Governance and Ethics
Melbourne Health Office for Research, Royal Melbourne Hospital, Australia

 

Andrew Wear
Director, Medical Technologies & Pharmaceuticals
Department of Economic Development, Jobs, Transport & Resources, Australia

Andrew is the Director of the Medical Technologies and Pharmaceuticals branch at the Victorian Department of Economic Development, Jobs, Transport and Resources (DEDJTR), where he leasd the development of government policy aimed at growing the economic impact of this sector. In this role, he also has responsibility for Victorian government science and innovation policy. Before joining DEDJTR, Andrew was a Director at the Department of Premier and Cabinet, leading the provision of advice to the Premier in a variety of policy areas, including: education; justice; energy; water; agriculture; and environment. He has also worked in a variety of executive roles with the Department of Planning and Community Development, and Regional Development Victoria. In 2007, he undertook a secondment with the OECD's Local Economic and Employment Development Program in Italy.


Elizabeth Wilson
Associate Director for Sites Relationships
IQVIA, Australia

Elizabeth worked initially in hospital and retail pharmacy roles before moving to the biopharmaceuticals industry. She has since worked in various clinical development and management roles with Agenix Ltd, Progen Pharmaceuticals Industries Ltd, and QuintilesIMS. Elizabeth is currently Associate Director for Sites Relationships for IQVIA Australia-New Zealand. Elizabeth completed her degree in Pharmacy (University of Queensland) and has postgraduate qualifications in clinical pharmacy. She has spent more than 20 years focusing on clinical hospital pharmacy and drug development, particularly in the area of clinical cancer services for paediatric and adult patients. Her current role involves working with sites and sponsors to increase the speed and efficiency of patient recruitment and clinical research in Australia and New Zealand to bring new medicines to patients faster.