Providing What You Need
I have a long tenure in industry, significant global experience and, having managed many services, a wealth of knowledge that spans much of the Clinical Development continuum.
If you're developing organizational or departmental strategy, need help selecting, establishing a partnership with or overseeing a CRO, or whether you're simply looking for someone to support your data services, I’m your go-to source.
Contact me today to set up a meeting and find out more about what I can do for you.
January 2022 - September 2023
Vice President, Clinical Research Units
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Member of the Early Development executive leadership team, providing and overseeing input to divisional vision, strategy and planning, commercial strategy and tactics.
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Delivered daily leadership to 3 fast-paced Clinical Research Units (total ~500 colleagues in clinic-floor roles, subject recruitment, quality, labs, and pharmacies).
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Directed operational, financial, and commercial performance, subject safety, and facilities.
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Oversaw strategy to drive differentiation and enhance CRU value.
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Single point of accountability and escalation point for issues; client-facing executive lead to address issues, ensure satisfactory resolution and maintain and manage client relationships as needed.
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Oversaw and supported bid proposals and bid defenses, while working with business development to drive additional study opportunities with new and existing clients.
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Provided hands-on operational support where needed.
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Provided review and approval of multiple legal documents related to the Early Development business.
June 2020 - December 2021
Vice President, Data Science Services
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Member of the Early Development executive leadership team, providing and overseeing input to divisional vision, strategy and planning, commercial strategy and tactics, etc.
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Developed department strategy for, grew, geographically expanded, and managed Data Sciences organization across Americas, Europe and Asia.
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Led introduction of new cross-functional deliverable to satisfy more cost-conscious clients, targeting greater standardization and stronger handoffs to reduce costs and cycle times.
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Developed and implemented key metrics to drive increased focus on performance and financial accountability, enhancing quality, speed, FTE utilization, revenue, and margins.
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Oversaw Data Sciences resourcing, prioritization, and operational delivery touching upto 200 studies annually.
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Provided hands-on operational support where needed.
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Provided review and approval of multiple legal documents related to the Early Development business.
August 2013 - June 2020
Vice President, Strategic Alliance Management
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Executive level VP for single, high-value, strategic accounts, partnering with clients to understand and fulfill their needs across any / all of the services we offered.
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Partnered with client and function stakeholders in development of partnership goals and operating models, creation of large multi-disciplinary operational teams and in ensuring operational and commercial delivery to agreed levels of quality / compliance.
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Selected right experts to provide clinical development guidance and consultancy
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Led successful bid defenses across multiple geographies resulting in award of high value, full service accounts.
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Chaired quarterly executive steering committees, represented executive on operational steering committees and responsible for relationship management at all levels.
October 2011 - July 2013
Vice President, Clinical Operations
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Oversaw and led Strategy and Operational delivery of a Clinical Operations team of 220 colleagues (project management, site/study management, clinical monitoring, clinical programming, data management, medical writing, contracts management), in support of phase I / II Biotech clinical research portfolio.
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Concurrently interim VP of Biostatistics for ~3 months during a period of organizational change.
April 2010 - September 2011
Chief of Staff, Development Operations
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Leadership thought partner for top 10 Pharma division of 10,000 FTEs with an annual budget of $1B
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Supported executive team in development of organizational strategy and goals
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Managed special projects including post-acquisition related activities
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Delegate for SVP Development Operations
1992 - 2010
US:
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Global Head, Medical Writing, Development Operations
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Clinical Excellence Award – delivered innovative vendor model and operational process significantly reducing costs and cycle times
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Director and group lead, Clinical Programming and Writing
Japan:
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Head, Clinical Operations Strategy Implementation
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Head, Biometrics Project Management
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Global biometrics consultant
UK:
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Biometrics team leader (Phase III)
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Biometrics team leader (Phase I)
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Lead statistician (Phases II-III)
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Lead Statistician (Phase IV)
Multiple Biometrics Roles in US, Japan, UK
Education and Certifications
1988 - 1992
B.Sc. Hons., Statistics
University of Bath, UK
2013 - 2014
Certificate in International Business Management
University College, Dublin, Ireland
2009
Six Sigma Green Belt
2005
Certificate in Advanced Japanese language proficiency
Tokyo, Japan
1998
Chartered Statistician (elapsed)