Celine M. Clive, President, has more than 30 years of experience in diverse areas of the drug development process, including positions in pharmaceutical companies and CROs. She has worked with sponsors, CROs, IRBs, and investigational sites to assure compliance with GCP regulations and has trained many clinical research professionals in GCP compliance. She’s the author of a reference book entitled “Handbook of SOPs for Good Clinical Practices” and was an alternate member of The Copernicus Group IRB. Ms. Clive is the former President of North Carolina Regulatory Affairs Forum and is a member of several professional societies. Ms. Clive has a BS degree in Biology from Wilson College in Chambersburg, PA and an MBA from Meredith College in Raleigh, NC.
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John Lowman, Business Development, has more than 20 years of global experience in consulting to the pharmaceutical industry. This includes experience in Clinical Development, Quality Assurance, Regulatory, Pharmacovigilance and Medical Writing. Mr. Lowman has a BS degree in Chemical Engineering from Lehigh University and an MBA from Columbia University.
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Jean Noblin, Resourcing Manager, has over 24 years of experience in virology research, clinical drug development from Investigational New Drug (IND) submission through regulatory submission, approval and marketing, medical writing, and change management at a major research-based pharmaceutical company and as an independent consultant. She has held positions as a clinical monitor, clinical project manager, medical writer and an International Product Development Team Leader (program director). In addition, Ms. Noblin has over 16 years of experience as a Clinical Resourcing Manager recruiting and managing consultants in clinical operations, medical writing, regulatory, safety and quality assurance for clients in the biopharmaceutical and device industries and serving as the primary client and consultant liaison. She has a BS in Zoology from North Carolina State University and a MS in Microbiology and Immunology from Wake Forest University in Winston-Salem, NC.
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Alkka Johnson, Projects Manager, is a life science professional with both a PharmD and MBA degrees from Campbell University. With a diverse educational background in pharmacy and strong business acumen, Alkka brings a unique skill set to the role of Project Manager at Polaris. Alkka collaborates with the talented team at Polaris Compliance Consultants to exceed client expectations and deliver exceptional results. With a passion for excellence and a dedication to ensuring compliance, Alkka is enthusiastic to make a significant impact in the success of Polaris clients.
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