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Early Phase Clinical Operations Strategist for emerging Biotechnology companies with a focus on strategic planning, operational execution, risk mitigation development programs. Executive Coach for those working through new positions or career transitions focused on strengths and core values. Creator of The Journey, an online Community for Professionals Seeking Learning, Growth and Making an Impact. Author Monthly leadership blog and newsletter.

Led the growing FIH Early Clinical operations team and Early Phase Development Center of Excellence
• Built and led a team of strong operational pioneers who were determined to deliver new oncology medicine via FIH basket trials. We reviewed and adapted study designs and processes to ensure we removed obstacles to delivering fast go/no go decisions for new solid tumor oncology targeted medicines.
• Created and led an Early Phase Center of Excellence to optimize learnings across FIH studies cross-functionally - focusing on operational efficiencies, global learnings and building site strategies & relationships across our early portfolio.
• Grew a high-performance virtual team to accommodate a 3x growth in our early phase portfolio with a lens for strategic planning including site utilization strategy. Focusing on efficiencies across the early portfolio including input for translational operational planning, global capabilities building to enable portfolio execution, including 9 new IN

Led the change management function to support an enterprise-wide project portfolio system adoption including resourcing, timeline and financial algorithms for data driven decisions.
• Managed a team of highly skilled experts in driving strategic initiatives and change management across the Pharmaceutical Development organization, primarily delivering technology and digital solutions to impact patient centricity, operational excellence, and smarter decisions through RWE, AI and machine learning.
• Aligned and prioritized the ongoing strategic initiatives by facilitating a strategic workshop with organizational VPs building out our SWOT, key capabilities required to deliver vision and design criteria to enable prioritization.
• AbbVie Lead Reprentative to TransCelerate - a global biopharma consortium focused on trial, data and patient alignment and streamlined processes.

Worked closely with TA, VP, and team to create clarity of expectations to drive to strategic vision of an emerging business pillar as Director of Strategic Planning and Operations for the Neuroscience Development TA.
Kathleen Harper Wisemandle 847.315.0181 Page Three

Senior Director, Head of Early Development Global Clinical Operations, June 2015 – June 2017 Director, Global Clinical Operations, December 2012 – June 2015 Associate Director, Clinical Program Management, February 2011– December 2012 Provided strategic vision and leadership for global clinical operations portfolio delivery (early and late phase): Including a team of two Directors, Program Managers and Study Managers.
• Identified internal opportunities to create efficient strategic cross-functional processes from preclinical research to clinical development (reducing cycle time by 3 months) focused on optimized CDP, protocol process, funding approvals, streamlined processes and early CRO engagement.
• Implemented early development strategic vendor partnership CRO services, CRO sites, bioanalytical and biomarker analysis; defining partnership KPIs.
• Created and expanded global team model to accommodate 2x portfolio growth supporting US and EU.
• Participated on Leadership Team for

Led remote North American based 50 CRAs and redefined monitoring strategy to enhance data retrieval to meet key milestones and risk management strategy. Directed project managers to support Phase 3 pivotal trials delivery to NDA.

Directed and developed global operations staff for registrational, observational and marketing dialysis studies across US, EU, Asia (including India). Corporate wide Clinical Operations lead for CTMS creation.

Led clinical operations teams for transplant clinical program delivery – provided input and an review for NDA, sNDA and applications in US, Brazil and Europe, including heart, liver and kidney transplantation and pediatric liver transplantation. Led cross-functional operational team for the full transplantation clinical portfolio. Participated in cross-functional work initiatives including EDC vendor assessment (move from paper environment), global SOP harmonization. Manage staff consisting of program managers, CRAs and CRO oversight.
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