09 Sep Boston Biomedical Associates Announces Senior Management Appointments
Marlborough, MA – Boston Biomedical Associates (BBA), a product development consultancy and full-service contract research organization (CRO) serving the medical device and biopharmaceutical industries, today announced three key appointments to the company’s senior management team.
Ken Dhimitri has been appointed to the newly created position of Vice President of Operations. Mr. Dhimitri, who has more than 15 years of experience in medical device and biopharmaceutical product development, will oversee Clinical Development, Regulatory and Quality Services at BBA.
“Ken’s proven industry track record and product development expertise make him an ideal choice to lead Operations at BBA,” said Lauren Baker, President and CEO. “Medical device and biopharmaceutical Sponsors are increasingly reliant on strategic collaboration with CROs. Ken’s appointment reflects our ongoing commitment to leverage global industry expertise, advance our clients’ pipelines and support their product development journey,” Baker remarked.
“With the CRO industry trending toward consolidation, an increasing number of medical device and biopharmaceutical Sponsors are looking for small and mid-sized development partners who are nimble enough to accommodate their needs. BBA provides highly customized solutions that afford Sponsors an opportunity to offset the risks inherent to partnering with larger strategic providers,” said Ken Dhimitri. “I am excited to lead Operations and leverage my experience to help our clients find innovative, cost-disciplined solutions in the design and execution of their development programs,” he added.
Prior to joining BBA in 2013, Mr. Dhimitri spent nine years at PAREXEL International where he worked in PAREXEL’s strategic partnership office, leading multiple global clinical development programs and a product development portfolio in excess of $300M. He previously held leadership positions in Project Management, Clinical Operations and Clinical Data Services.
Mack Rubley PhD is promoted to the newly created position of Vice President of Consulting Services. Dr. Rubley, who has more than 15 years of experience in sports medicine, clinical research and medical device product development, will oversee Consulting Services at BBA.
“Mack’s background as a clinical scientist paired with his strategic mind-set allows him to match clients’ research needs to the best BBA experts. I am excited that Mack will be utilizing these partnership skills as the VP of Consulting Services to expand the strategic impact BBA will have across the industry.” said Lauren Baker. “Under Mack’s leadership, BBA will continue to collaborate with global regulatory agencies and Sponsors to bring unique and innovative new products to market,” she added.
“This new position allows BBA to further expand our leadership position as a clinical and regulatory strategist for medical device and biopharmaceutical companies,” Mack Rubley stated. “I am honored to accept this opportunity of leadership. Our outstanding group of experts will continue to partner with clients in the development of innovative, cost-conscious, study designs and global regulatory strategies to bring products to market sooner,” he noted.
For the past three years, Dr. Rubley has been leading BBA’s business development function. During that time, BBA has seen impressive growth in service offerings, revenue and client partnerships. Prior to joining BBA, Dr. Rubley was an Associate Professor of Athletic Training in the School of Allied Health Sciences at UNLV for 10 years and the Director of the Athletic Training Education Program and the Therapeutic Modalities Research Laboratory from 2006-2011. His previous experience directing a research program positions him to balance the scientific and business aspects of product development.
Maria Francescon has been appointed to the position of Executive Director, Clinical and Safety Operations. Ms. Francescon, who has more than 15 years of experience within the medical device and pharmaceutical industry, will oversee Clinical and Safety Operations at BBA.
“Maria’s tenacity and strong leadership skills are a great asset to our clients and their clinical trials,” noted BBA’s President and CEO Lauren Baker. “As BBA continues to execute large clinical trials globally, I am confident Maria’s skills and experience will yield innovative trial management solutions for BBA’s clients,” she added.
“With clinical trial complexity increasing, medical device and biopharmaceutical Sponsors are looking for efficient yet innovative methods to ensure patient safety and data integrity,” said Maria Francescon. “I am excited to lead Clinical and Safety Operations at BBA. I look forward to helping our clients execute safe and effective clinical programs.”
Since joining BBA in 2012, Maria has expanded Safety Operations service offerings and refined Data Monitoring and Clinical Event Committee procedures. She has leveraged best practices from her experience in the industry. Prior to working at BBA, Ms. Francescon spent 10 years at Harvard Clinical Research Institute (HCRI), overseeing Clinical Event Committee and Data Monitoring Committee services. In this role, she contributed to the success of the business unit and its growth as a niche service provider to Sponsors.