|Kelley Kendle, President
A long-tenured Synchrogenix executive Kelley Kendle possesses a keen understanding of the regulatory landscape, coupled with a strong focus on client relationships. Ms. Kendle has been instrumental in developing services and cultivating staff to address our industry’s needs. With more than 13 years of experience in regulatory writing consulting, she is both an internal and external subject matter expert. Along with our leadership team, she will drive the company’s strategic growth, business process, and organizational dynamics.
|Steve Sibley, Vice President, Global Submissions and Submission Leadership
With a career spanning more than 25 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and clinical project leadership roles. He has successfully supported projects from discovery through approval and life cycle management. These include significant roles in more than 50 submissions and, in several cases, leading the entire submission team overseeing all documentation from Modules 1 through 5. Mr. Sibley drives the expansion of the company’s submission leadership and consulting capabilities in guiding clients to successful clearance of regulatory milestones.
|Kelley Hill, Director, Global Submissions — Orphan Drug and Rare Disease
has over sixteen years of pharmaceutical experience in drug development from target identification through regulatory submissions and post-marketing activities with an additional 16 years in academic experience across the life sciences.
|Stephanie O'Keefe, Director, Internal Operations
oversees administration and facilities management for Synchrogenix’s eight global locations. Ms. O’Keefe drives recruiting and hiring worldwide to ensure continued growth and development of the company’s most valued asset, its employees.
|Lauren Sobocinski, Director, Client Services
has core responsibilities in new business development, client management and satisfaction, and marketing. Ms. Sobocinski’s career in the pharmaceutical industry and consultative approach provide Synchrogenix clients with the valuable expertise necessary to achieve their goals.
|Kim Green, Director, Team Leads
has written and oversees Synchrogenix’ in-house staff writers and document quality specialists across the global offices.
|Tatyana Wanderer, PhD, Director, Strategic Partnerships and Alliances
responsible for effective and efficient collaboration with industry partners and Certara business divisions