Resume


Kathleen (Kay) J. Monroe

Walnut Creek, CA 94597

[email protected]            
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Summary

Decision-maker well-versed in executive level responsibilities; used to motivating teams/departments of all sizes. In-depth experience in project management and PMO set-up ensures rapid completion of tasks. Strong financial skills support a proven ability to maintain cost control. In-depth clinical operations experience from Phase 1 to 4 and some physician-sponsored studies. Experience working in multiple therapeutic areas (CV, CNS, growth factors, vaccines, oncology), medical devices and CROs. Agent for change, integration specialist, team player and skilled implementer of strategic plans.


Experience

2005–present
Cayman Scientific Consulting, LLC, Walnut Creek, CA                  
President
Clients supported: Daiichi Asubio Pharmaceuticals Inc., Helicon Therapeutics, Center for Professional Innovation and Education, Dynamic Resource Management (division of the Cambridge Group), Zagaya
Senior-level consultant providing project management and training to pharmaceutical and biotechnology companies. Responsibilities range from acting as Project Team Leader to managing CROs, negotiating outsourcing contracts, providing organizational development expertise and classroom training on a variety of subjects.

2010–2012
Amyris and Zagaya, Emeryville, CA                  
Executive Director
Hired by renewable chemical company to start a non-profit entity (Zagaya) working in malaria. Created corporate entity, filed and obtained 501(c)3 status; wrote and received Gates Challenge Grant; created, organized and implemented World Malaria Day for local groups working in malaria. Worked one year for Amyris, one year for Zagaya and then moved into consulting role.

2010–2011
Synarc Inc, San Francisco, CA                  
Vice President, Imaging Services
Niche CRO providing management of imaging for global clinical studies; Responsible for Clinical Operations, Clinical Project Management and Radiology Departments (~130 employees) servicing over 150 clients in biotech, pharma and medical device industry.

2008–2010
Institute for OneWorld Health, San Francisco, CA                  
Vice President, Project Management & Quality Assurance
Team Leader, Malaria Program
Responsible for leading the Artemisinin Project, which developed a semi-synthetic pre-API for use in ACTs, the WHO recommended treatment for malaria in developing countries. This project involves multiple external partners, stakeholder management and global health initiatives. Headed up the PMO and the QA Dept to support a growing drug development organization.

2006–2008
Dynavax Technologies, Berkeley, CA                  
Director, Project Management
Primary Project Manager for Lead Compound in Vaccine Portfolio. Included: 
  • BLA Preparation
  • Holder of Project Timeline and Budget
  • Implemented (with Finance) project-based budgeting for the company

2002–2005
Lundbeck Research USA, Paramus, NJ                  
Vice President, Operations (2003-2005)
Responsible for all non-scientific operations of Lundbeck Research USA (formerly Synaptic Pharmaceutical Corporation), a subsidiary of the Danish Pharmaceutical company, H. Lundbeck A/S and for delivering qualified CNS discovery compounds to the pipeline. Operations included ~35 employees in Corporate Communications, Facilities, Finance, Human Resources, IT (Corporate and Scientific) and Legal.
  • Reduced operating costs > 15% annually; responsible for $35MM operating budget, $23MM construction budget
  • Founded Communications Department to support corporate goal of raising awareness of Lundbeck in the USA; awarded "Best Employer 2005" by NJ Business Innovation Association
  • Established and staffed Human Resource function; moved from self-insured to PPO, developed and implemented performance management system, created highly competitive benefits package
  • Converted Legal into a functioning patent office, reducing costs and eliminating use of external firms

2002–2003
Synaptic Pharmaceutical Corporation, Paramus, NJ
Director, Project Management
Responsible for Clinical Operations/Regulatory; managed external CROs for Phase 1/2, provided oversight of Preclinical Safety/Toxicology/CMC to ensure project scope, timelines and budget were met. Project Manager for lead development compound. Supported evaluation of development portfolio and research pipeline.
  • Initiated company-wide SOP and Documentation Management System
  • Introduced Project Management Tools and Techniques for drug development teams

1999–2001
Cerus Corporation, Concord, CA
Director, Project Management
Established and built Cerus’s PMO which manages all project planning, communication, reporting and budgeting for the Development portfolio and Research pipeline. Developed and implemented tools for tracking and auditing project status. Introduced the strategic planning tool to prioritize development programs and ensure fit with the company’s overall business strategy. Managed and supported all external collaborations with R&D partners.
  • Submitted first stage of CE Mark application (TUV–EU) for Intercept™ Platelet product 
  • Submitted first two modules of the PMA filing to the FDA for Intercept™ Platelet product
  • Led the reorganization of the company into functional R&D areas with project team focus
  • Managed the collaboration with Kirin Pharmaceuticals as Member of the Development Committee
  • Chaired the SubTeam for Implementing new Governance Committees at the company

1995–1999
Genentech Inc., South San Francisco, CA
Project Manager
Managed Project Teams and supported the implementation of the Product Development Plan (PDP). Identified and resolved project issues, recommended course of action on development issues, presented to senior management committees on project plans, proposals and budgets. Coached and mentored project team members on managing the drug development process, the project budget, project management tools and team dynamics.
  • Developed and implemented an intranet-based team folder system for sharing, editing and safekeeping of critical team documents. Established a web-based system to do the same between Genentech and European partner which included submission documentation for both a US and EU filing
  • Project Manager for Nerve Growth Factor and Oral IIbIIIa inhibitor
  • Completed small  (n=200) and large (n =1,000) Phase II and III clinical programs


Other Experience 

LabTools Inc., Concord, CA (COO)
Costar Corporation, Pleasanton, CA (Sales Rep)
Genentech Inc., South San Francisco, CA (Manager, Bioassay Services)


Education and Other Relevant Training

MBA, Golden Gate University, San Francisco, CA
BS (Animal Science), University of California, Davis, CA

Program on Negotiation at Harvard Law School, 2005
Strategies for Enhancing Executive Influence at Harvard University, 2005
Coverdale Team Training, 2004


Professional Affiliations and Other Accomplishments

National Association of Female Executives (NAFE)
Project Management Institute (PMI)
Drug Information Association (DIA)
Founder, East Bay Chapter of the Association for Women in Science (ebAWIS); President (1993–94) 
Board Member, Armenian Women’s Archives
Emmy Project (STEM) for Boys Hope, Girls Hope