Karen is a Senior Partner with tranScrip and brings 26 years of experience working with large and small pharmaceutical companies, biotechs and CROs. Karen has a wealth of experience in the leadership of cross functional clinical study and development teams and has a successful track record in the design, budgeting and execution of clinical programs supporting several product approvals.
Strengths include team leadership, project/program management, risk and issue identification and management, clinical development plans, data quality and integrity, inspection readiness/conduct and vendor evaluation, selection and oversight. Karen has a successful track record of the hiring, developing and leading clinical operations and data management teams and for developing highly collaborative, motivated cross-functional product teams.
Karen joined tranScrip from Summit Therapeutics where she was VP, Clinical Operations, where she hired and led the clinical, data management and project management functions and led the cross functional clinical development team. Karen successfully initiated Summit’s first Phase 3 clinical program in C.difficile infection and was a key member of the company’s leadership team.
As VP, Clinical Operations with Shield Therapeutics, Karen was part of the company’s leadership team where she supported the selection of a 2nd therapeutic indication for the lead product and initiated the registration study.
Prior to Shield, Karen spent 8 years at Biogen where she led 5 cross functional clinical development teams, including ownership of the CDPs. Two of these programs were novel hemophilia replacement factors (Eloctate and Alprolix) from Phase 1 through NDA submissions, approvals (including the US, Japan, EU), pediatrics (PIPs/PDPs) and life cycle management planning. The other programs were late stage multiple sclerosis products two of which received EMA, FDA/EMA approvals.
In addition to program management, Karen has significant experience in leadership of cross functional clinical study teams for Biogen, Pfizer and Napp Pharmaceuticals in several therapy areas including oncology (thyroid, breast, renal cell, NSC lung and melanoma), heart failure, detrusor hyperreflexia, IBD, asthma, male and female sexual dysfunction, and rheumatoid arthritis.