Synteract Management Team

Ellen Morgan
CEO/President, co-founder

As co-founder, CEO and President of Synteract, Ellen Morgan has established the corporate vision and business strategy for the company. Ellen has over 25 years experience in clinical research. She is a renowned expert in data management, statistics, clinical information systems and successfully preparing and submitting studies to the FDA.

Prior to founding Synteract, Ellen held positions with:

• Gensia, Inc. as Director of Data Management and Statistics
• Pfizer, Inc. as Manager of Clinical Data Operations
• Sterling Drug as Project Coordinator, Clinical Data Management

Ellen holds a Bachelor’s degree in chemistry from Siena College in Albany, New York and a Master’s in management engineering/statistics from Rensselaer Polytechnic Institute in Troy, New York.

Ellen has been recognized multiple times by various professional and business organizations. In 2008, Ellen was the winner in the services category of the Athena Pinnacle Award, which recognizes organizations that, through the development and promotion of skilled and talented women, have had a significant impact within the San Diego technology, life science and healthcare sectors. She was a finalist for the Ernst & Young Entrepreneur of the Year Award in 2006 and semi-finalist again in 2008.

 

Russell Holmes
Executive Vice President, co-founder

Russell Holmes has been working in the clinical research industry since 1987 and, as co-founder, has been instrumental in the development of Synteract since the very beginning. He is responsible for the operations of the IT department, including networking, help desk, databases and software development, as well as the business operations department comprised of finance, human resources, office administration and real estate/leasing. He is also involved in corporate governance, business development and quality assurance for the company.

Prior to founding Synteract with Ellen Morgan, Russ worked for:

• Gensia, Inc. as Manager of Project Information Resources
• Pfizer, Inc. as Senior CANDA and Statistical Data Analyst
• Montefiore Medical Center as Planning Analyst

Russ holds Bachelor’s degrees in computer science and mathematics and a Master’s in business administration from Sacred Heart University in Fairfield, CT. He was a recent finalist for the Technology Executive of the Year award from the San Diego Business Journal.

 

Stewart Bieler
Vice President, Clinical Operations & Project Management

As Senior VP of Clinical Operations and Project Management, Stewart is responsible for the management of the clinical operations, project management and medical writing departments. Stewart has worked in the industry since 1987 and is well versed in the entire clinical development process. He has been with Synteract since 1999, and has been instrumental in the growth of Synteract to becoming a full-service clinical CRO, specifically developing the clinical operations and project management service offerings.

Prior to joining the Synteract team, Stewart worked for:

• Dura Pharmaceuticals, Inc. as Senior Manager of Regulatory Submissions
• Gensia, Inc., as Manager of Clinical Development

Stewart holds a Bachelor’s degree in economics from Stanford University.

 

Steve Preiss
Vice President, Corporate Regulatory & East Coast Business Operations

Steve has 30 years of industry experience with 25 years focused on clinical research and development. He joined Synteract in 2001 and is responsible for general Business Development, for project management and regulatory support of Synteract's Device Client Companies and for project management of Biotech/Pharma Clients located in the Eastern through Mid-West U.S. locations.

Prior to Synteract, Steve held positions for:

• UroSurge, Inc. (Medical Devices - Urology) as Vice President of Clinical and Regulatory Affairs
• Bio-Pharm Clinical Services as Vice President, Clinical Programs & Data Management
• Ioptex, Inc. (Medical Devices, Ophthalmology) as Clinical Programs Director

Steve holds a Bachelor’s degree in chemistry from St. Lawrence University in Canton, N.Y., and completed Masters work (in Computer Science) at Union College in Schenectady, N.Y.

 

Marilyn R. Carlson, D.M.D., M.D., RAC
Vice President, Medical & Regulatory Affairs

Maryilyn Carlson joined Synteract in 2004 and is responsible for medical, regulatory and safety services. She has over 17 years of experience with small, mid-size and large companies in the development and post-marketing support of drugs, biologics and diagnostics. Marilyn’s high level medical/clinical background and broad range of therapeutic expertise make her an integral part of the Synteract team.

Prior to working with Synteract, Marilyn held positions for:

• U.S. Agent for non-U.S. companies seeking FDA approval
• entreMeDica, Inc. (a consulting company) as Founder and President
  
• Prometheus Laboratories, Inc. as Chief Medical Officer and Vice President of Medical/Regulatory
  
• Ista Pharmaceuticals as Chief Medical Officer and Vice President of Clinical and Medical Affairs
  
• XOMA as Vice President of Clinical & Medical Affairs
  
• Proctor & Gamble Pharmaceuticals as Worldwide Technical Brand Manager and Medical Director of Medical Affairs
  
• Proctor and Gamble Healthcare as Medical Director of Worldwide Medical Affairs

Marilyn holds a Bachelor’s degree in anthropology and biology from Hunter College in New York City, A Doctor of Dental Medicine (DMD) degree from Harvard and a Doctor of Medicine degree (MD) from Case Western Reserve University in Cleveland. She completed residencies in Geriatrics and Special Patient Care at Long Island Jewish and Internal Medicine at the Cleveland Clinic Foundation. Marilyn also has a Regulatory Affairs Certification from the Regulatory Affairs Professionals Society.

 

Elaine Kelley
Senior Director, Clinical Operations

Having been in the pharmaceutical and biotechnology industry since 1981, Elaine is especially qualified to serve as Synteract’s Director of Clinical Operations. Elaine is responsible for oversight of the clinical operations area, clinical resourcing, and clinical trial management.
In her career, Elaine has worked primarily in the area of clinical research and development and has extensive experience in the design, monitoring and management of all phases of clinical trials. Additionally, she has medical writing experience for regulatory submissions and scientific publications.

Prior to her position at Synteract, Elaine worked for:

• Allergan, Inc. as a Clinical Research Associate and Manager, Clinical Research
  
• The Immune Response Corporation as a Director, Clinical Operations

Elaine holds a Bachelor’s degree in biological science from the University of California, Irvine.

Ali Sadighian
Director, Business Development

Ali has been in R&D and clinical development for over 15 years, and with Synteract since 2006. As Director of Business Development, he is responsible for assessing and managing new business opportunities as well as developing, leading, and participating in both general capability and proposal presentations to study sponsors. In this role he is also a primary team member overseeing Synteract’s advertising, promotional programs, public relations, and trade shows, including Internet-based communications.

Before Synteract, Ali held positions for the following companies:

• Monitorforhire.com as Manager, then Director of Clinical Operations
  
• PRA International as a Senior Clinical Research Associate (CRA)
  
• Quintiles, Inc. as a CRA, then Senior CRA
  
• The Immune Response Corporation as a Quality Control Associate
  
• The University of California as a Staff Research Associate

Ali holds a Bachelor’s degree in General Biology from the University of California in San Diego.

Mark Knowles
Principal Statistician

Mark Knowles joined the Synteract team in 2002, and is responsible for providing statistical expertise in study design, data analysis and reporting in a range of therapeutic areas including: oncology, ophthalmology, cardiovascular, and gastrointestinal. He also writes statistical methodology sections and analysis plans for study protocols and reports.
Mark assists Synteract clients with the statistical aspects of regulatory strategies and provides representation at regulatory meetings.

Prior to joining Synteract, Mark worked for:

• Maxim Pharmaceuticals, Inc. as Senior Director of Biostatistics
  
• Agouron Pharmaceuticals, Inc. as Director and Head of Biostatistics
  
• Gensia Pharmaceuticals, Inc. as Associate Director of Statistics
  
• ALZA Corporation as Manager of Biostatistics

Mark holds a Bachelor’s degree in Mathematics from Simon Fraser University in Burnaby, B.C., Canada, and a Ph.D. in Statistics from Stanford University. He is an active member of the American Statistical Association, and is an author on numerous published articles.