Craig Stone, PhD
Denver,CO
Summary
Highly experienced People Manager with 9 years of experience within the Medical Device industry. Experienced in managing high performing teams and effective in cross-collaborating with global and regional teams. Proficient in clinical strategy, medical/scientific communications, and regulatory requirements including EU MDR. Results-oriented leader with an analytical approach to problem-solving.
Overview
13
13
years of professional experience
Work History
Manager, Clinical Sciences and Communications
Medtronic Neurovascular
04.2021 - Current
- Lead Clinical Communications and Strategy activities for Acute Ischemic Stroke (AIS) portfolio
- Manage high performing team of Medical Writers and Medical Science specialists to complete Clinical Evaluations, Clinical Study, and Clinical Communications activities
- Clinical strategy lead for real-world clinical registry activities including development of study protocols and cohort designs
- Lead initial evidence dissemination activities for global registry
- Clinical core team member for new product development including global evidence strategy
- Partner with marketing to develop clinical claims, clinical evidence summaries, and create educational content for promotional materials and sales force education to drive business growth
- Lead completion of clinical communications deliverables including key publication alerts and conference summaries
- Develop abstracts, posters, and conference presentations
- Led remediation of all Clinical Evaluation documents for AIS products to compliance with EU MDR
- Lead Clinical point of contact for internal and external audits
- As workstream lead, developed enterprise content management requirements for AI-based tools
- Key committee member for development and maintenance of Medtronic enterprise Clinical Evaluation templates and procedures
- Develop and maintain Clinical Evaluation templates, SOPs, and supporting documents for Neurovascular Operating Unit
- Lead software validation activities for CER efficiency software
- Lead manager for use of Power BI and other data analytics methods for analyses of complex clinical data
- Lead manager of quarterly Clinical Sciences and Communications engagement survey to drive employee engagement and productivity
- Lead journal clubs and other educational activities for cross-functional audiences
- Experienced in cross-functional partnerships including Clinical Operations, Biostatistics, Medical Safety, Data Quality, Regulatory Affairs, Quality Affairs, Post-Market Vigilance, and Project Management Office
Principal Medical Writer and Manager
Medtronic Medical Surgical
07.2019 - 04.2021
- Managed and coached team of direct reports and functional reports to complete CERs in accordance with internal requirements and EU regulations
- Direct authorship of CERs, CEPs, and PMCF reports for new and existing Class I-III devices
- Led remediation of all CERs within Gastrointestinal portfolio to compliance with MEDDEV 2.7.1 Rev 4
Senior Medical Writer
Medtronic Medical Surgical
04.2015 - 07.2019
- Developed CERs to meet requirements of MEDDEV rev4
- Drove alignment on resources, timelines, and expectations with global cross-functional partners
Medical Writer II
EBSCO Health
04.2011 - 04.2015
- Generated summaries of published clinical trials for point-of-care medical database
Education
PhD - Cell and Molecular Biology
University of Pennsylvania
Philadelphia, PABA - Biochemistry and Molecular Biology
Clark University
Worcester, MASkills
- Implementing processes and procedures
- Executing Clinical Evaluations per EU MDR
- Coaching and mentoring
- Clinical communications
- Real-world evidence strategies
- Implementation of AI-based tools
Timeline
Manager, Clinical Sciences and Communications
Medtronic Neurovascular
04.2021 - Current
Principal Medical Writer and Manager
Medtronic Medical Surgical
07.2019 - 04.2021
Senior Medical Writer
Medtronic Medical Surgical
04.2015 - 07.2019
Medical Writer II
EBSCO Health
04.2011 - 04.2015
PhD - Cell and Molecular Biology
University of Pennsylvania
BA - Biochemistry and Molecular Biology
Clark University
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