Lead the Global Clinical Development Organization and oversee the US HQ Research Clinic in Westford. As the Senior Director of Global Clinical Development, be responsible for supporting all Clinical Development activities and generating all the Clinical data to support Regulatory submissions and sustaining product compliance.Jennifer shared, "I am excited about my new role as the Unified Cynosure Lutronic team, I am dedicated to building collaborative partnerships across departments, and I am eager to embark on this new chapter with the shared vision of delivering innovative, evidence-based solutions that set the industry standard.”

Oversees all aspects of the clinical development department. Executes clinical studies in the United States and supports clinical studies globally. Preliminary contact for clinical study design, strategy, and implementation with key opinion leaders. Instrumental in assisting with regulatory submissions (such as 510(k)s) and also for insuring study deliverable s are attained; clinical studies are published and/or presented at the various trade meetings Cynosure attends globally.

-Coordinated with project managers and tracked all aspects of ongoing clinical research study projects for the department.-Assured regulatory requirements are met. -Maintained status reports. -Designed and created protocols as well as all associated study documents for clinical studies.-Directly coordinated clinical study sites and project management duties as needed. -Managed IRB relationship. -Managed relationship with Cynosure's regulatory department to determine that study design and investigational plans met the regulatory objectives. -Assisted in the compilation/writing of and clinical sections to support regulatory filings. -Directly managed a team of Clinical Research Associates to assist with data collection, quality checks, analysis and formulating study output.

-Acted as the main line of communication between the sponsor and the investigator-Project coordination, planning and logistics, including; study submission, inititiation/training visits, monitoring visits, overview of budget and timelines-Verified that all research staff, facilities and investigational products have adequate qualifications and resources-Verified that the investigator follows the approved protocol and all IRB/ICH/GCP/FDA procedures-Verified that source data/documents and other trial records were accurate, complete, and maintained-Reviewed adverse events, concomitant medications, and inter current illnesses to assure that they were reported accordingly-Communicated deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator-Created preliminary statistics and data summary reports for journal submissions and conference presentations-Provided data to support R&D, engineering, marketing and sales departments-Supported regulatory in FDA 510k and IDE submissions

-Assisted with preparing documents for IRB submission (forms, protocols, CRFs)-Supplied study centers with sufficient study supplies-Collected and authenticated CRFs-Performed monitoring visits (50% travel at 15 study locations)-Wrote study summaries, presentations and created photographic PowerPoints-Developed and performed image analysis protocols (e.g. breast lifting, hyperhidrosis, 3D analysis of cellulite)-Conducted clinical study protocols in accordance with IDE requirements

-Compiled data to build Sitetrove, a database that tracks and maintains detailed global profiles on clinical investigators and sites.-Interacted with geographically dispersed team members.-Trained and coordinated a team of Research Associates on project specific tasks.-Performed daily quality checks on the team’s actions within the database.-Developed team and project status report results from database exports and in Microsoft Excel (including; training statistics, team accuracy, and project completion).-Assisted in managing projects and documentation of the databases’ construction.-Maintained ad hoc database exports per client requests.

-Provided excellent customer satisfaction by knowing the inventory and being able to ask probing questions to help diagnose issues and make recommendations for car repair-Worked as cashier to process sales and credit card receipts-Provided added value to customers by offering additional services or warranties on purchases-Maintained accurate inventory, assured that products were always prominently displayed and that shelves were never empty-Audited registers and deligated tasks to sales team

-Tracked and entered incoming clinical data and imaging into a project specific database-Reviewed clinical data for discrepancies-Generated automated and manual Data Clarification Forms (DCF) for corrections to illegible, inconsistent and/or missing data-Trained and coordinated a team of Research Associates on FDA regulations and trial specific procedures-Performed daily quality checks on team’s actions within the database-Interacted and trained investigator sites worldwide on trial specific protocols, data acquisition, documentation and on follow up issues-Performed computer-based analysis on medical images for clinical trials-Converted medical image data to digital format (including; CT, MRI, X-Ray, Ultrasound, EKG, PET). Experience with oncology (breast, colorectal, lung), CNS (Stroke), Cardiovascular (Arrhythmias, Cardiovascular safety endpoints in oncology and neurology), musculoskeletal (arthritis, orthopedic devices) protocols-Obtained experience in large multi center studies with upwards of 3,000 patients and 250 locations.

- Prepared chemical buffers, targets and reagents.- Performed laser induced fluorescence and ultraviolet capillary electrophoresis.- Ran a variety of High throughput Screening assay formats such as; dose response, competitive inhibition, protein-protein interactions and nucleic acid-protein complexes to test potential drug targets.