Mary Kay Seeland

Mary Kay Seeland has over 30 years of work experience in various roles within the pharmaceutical and biotech industry. Mary Kay currently serves as the Sr. Director of Clinical Operations at Karuna Therapeutics since May 2019. Prior to this, they were the President/Consultant at MKS Pharma Consultants LLC from September 2017 to May 2019, where they provided consulting services specializing in change management, process improvement, and clinical compliance.

From September 2014 to May 2017, Seeland worked as the Executive Director of Clinical Operations, Global Study Start Up & Document Management at Premier Research. Mary Kay also held the position of Director of Clinical Planning & Study Start Up at Premier Research from September 2012 to September 2014.

Before joining Premier Research, Seeland worked at PRA International as the Manager of Clinical Operations from May 2011 to September 2012. Mary Kay was responsible for overseeing and implementing quality initiatives and business processes. Mary Kay also managed a team of CRAs and supported the career development of staff members.

From June 2010 to May 2011, Seeland worked at Amicus Therapeutics as the Document Control Manager. Their responsibilities included supporting audits and inspections, managing audit reports and CAPAs, and ensuring compliance with regulations and company policies.

Seeland's earlier experience includes working as the CRA Manager at ZeeCRO, Inc (formerly AAIPharma) from June 2007 to April 2010, and as the Manager of Regulatory Affairs at West-Ward Pharmaceuticals from June 2005 to October 2005.

Mary Kay also worked at PRA International for several years in the role of Senior Manager of Document Management from December 1999 to January 2005. In this role, they supervised and coordinated activities within the Document Management Department.

Seeland began their career at Carter-Wallace Inc. in March 1987 and worked there until August 1998 as the Administrator of R&D Documentation. Their responsibilities included managing regulatory records and documentation for clinical studies and liaising with licensors.

Overall, Seeland has a wealth of experience in clinical operations, project management, quality assurance, regulatory affairs, and document management within the pharmaceutical and biotech industry.

Mary Kay Seeland attended Middlesex College from 1988 to 1991, where they pursued a field of study in Nursing. After completing their studies at Middlesex College, Mary Kay went on to enroll at Rutgers University. From 1991 to 1998, they studied Communication, Information, and Library Studies and graduated with a Bachelor of Arts degree from Rutgers University.