Lisa Walker

Background

About Lisa Walker

THE VALUE I BRING R&D leader with 20+ years of experience directing preclinical safety strategy for pharmaceutics and medical devices. Working within the biotechnology/pharmaceutical sector has been a very rewarding experience, since it allowed me to combine by love for science with the ability to contribute to delivering new products that improve people’s health and quality of life. I am also proud of my efforts to grow, expand, and reshape the preclinical safety team and its capabilities to meet the growing needs of Alcon in compliance with regulatory changes of the medical device industry. A FEW CAREER HIGHLIGHTS & QUALIFICATIONS - Diplomate of the American Board of Toxicology (D.A.B.T.) and Ph.D. in Interdisciplinary Toxicology- Directed preclinical safety programs for 20+ programs and acquired robust regulatory submission experience across CE mark, IDE, PMA, 510(k), IND, NDA, MAA, and Japan, China, and South Korea device applications for a company with >7B in annual revenue- Extensive experience creating MDR compliant CE mark dossiers for biocompatibility aspects of class II and medical devices. Provided leadership to ensure on-time transition of ~ 100 preclinical (biocompatibility) technical files for marketed and in-development medical device products to new EU Medical Device Regulation (EU MDR)- Led the development and validation of a finished product release test assessing inflammation for ophthalmic viscosurgical devices (OVDs). Actions included method development, validation, transfer to MTO operations, and global registration of the method- Led preclinical risk management across all stages of the development lifecycle; applied knowledge of GLP/ISO quality systems and end-to-end operations including study execution, quality, compliance, procurement, audit participation, vendor contracts, animal sourcing and logistic execution- Built a best-in-class in vivo and in vitro operations team within R&D Preclinical Safety (PCS) Unit. Scaled PCS group to assume global preclinical safety accountability for medical device products- Established productive working relationships across 5 R&D sites in the US and Europe to collaboratively enable optimum progress on medical device product development- Coauthored over 25 manuscripts and conference presentations. MY CONTACT INFORMATION You can network with me here or email me at lmw2004@charter.net