Professional Experience

Cynthia Lacker, RN, MS, CPHRM

Currently:  Mallinckrodt Pharmaceuticals

Director, Clinical Education, Immune Cell Therapy, North America

Direct the Therakos Clinical Specialist Team in North America in the provision of excellent, compliant onsite clinical training and remote clinical and technical support to Clinicians responsible for prescribing and administering THERAKOS ® Photopheresis therapy using THERAKOS® CELLEX® Photopheresis systems.  Development of national clinical account management program to effectively manage and quantify national training effort. Complete revision of educational material and tools used by national training team to maximize positive clinical training outcomes of both proactive and reactive training sessions.  Manage 3.2 MM budget to execute on strategic goals. Liaise with key industry stakeholders to improve clinical provision of photopheresis therapy. Lead the North American clinical execution of Phase II Clinical Studies including Clinical SOP and training material development, Site Initiation Visit training and real-time study center support.  Lead global cross-functional collaboration with business stakeholders to build, maintain and improve excellence in the provision of photopheresis therapy to achieve corporate milestones and goals.

2013 DePuy Synthes, a Johnson & Johnson Company
Clinician, Product Safety and Performance
Responsible for post market product safety and performance. Mandatory participant in Health Hazard Evaluations, articulating potential patient safety and risk consequences of a diverse portfolio of marketed devices. Driver of consistency and accuracy across multiple operating companies.  Complaint trending and analysis. Development of tools and methodologies to capture and categorize medical device risk.

2012 Siemens Medical Solutions, Malvern, PA
Global Regulatory Analyst
Global Regulatory Analyst responsible for a diverse portfolio of healthcare IT solutions, with a focus on ensuring patient safety, regulatory compliance, quality and usability issues.  Key member of the Risk Management and Patient Safety Core Teams. Responsible for analyzing emerging regulations and trends to maintain competitive, quality-driven focus.

2011 ECRI Institute Patient Safety Organization, Plymouth Meeting, PA
Senior Patient Safety Analyst/Consultant
Project management of health-system level patient safety organization enrollment including marketing, recruitment, c-suite presentations, kick-off planning, on-boarding of facilities, program monitoring, and continuing education via onsite training, webinars and teleconferences.

2009-2011 ECRI Institute, PA-PSRS Group, Plymouth Meeting, PA
Senior Patient Safety Analyst/Consultant
Analyze serious event reports for patient safety trends and triggers; develop evidence-based risk mitigation strategies via medical research; facilitate state-wide patient safety initiatives.

2008-2009 University of Delaware, Wilmington, DE
Faculty Member, Legal Nurse Consulting Certificate Program
Developed and presented curricula related to the profession of Legal Nurse Consulting.

2008 PESI Inc.  
Traveled nationally to present day-long seminars to physicians, nurses and risk managers regarding legal issues surrounding documentation.

2005-2007 Litigation Management, Inc., Mayfield, OH
Clinical Analyst
Performed medical record review and analysis in defense of pharmaceutical litigation.  Case triage and complex report writing, integrating medical and legal knowledge. 

1997 - 2005 Lacker & Associates, Colorado and Pennsylvania
Principal, Senior Consultant, Project Manager
Senior consultant in the patient safety, risk management, quality improvement and medical-legal domains. Large scale project management, data and medical record analysis, scientific and technical writing, and risk mitigation strategy development.

Sergeant, US Army
German Linguist; Top Secret Security Clearance
Honorable Discharge