EU MDR Compliant StrategiesHighly skilled consultant with in-depth knowledge of EU MDR (2017/745) requirements and a proven track record of simplifying compliance. Extensive experience developing clinical, medical, and regulatory strategies and documents, and interfacing with regulatory bodies for Class I, IIa, IIb, and III medical devices across diverse therapeutic areas. Providing consulting services in the following areas:Clinical & Regulatory Affairs: Develop comprehensive strategies for regulatory compliance that are operationally feasible and designed within business constraints of budget, timelines, and risk tolerance. Lead PMCF teams, manage external contractors, and interface with Notified Bodies.Medical Writing & Documentation: Develop/Review Clinical, Medical, Regulatory, and Process documents, including:• Clinical Study Protocols, Reports, and other study documentations• Post-Market Clinical Follow-up (PMCF) Plans, and Reports• Post-Market Surveillance (PMS) Plans, and Reports• Systematic Literature Review Protocols, and Reports• Clinical Evaluation Plans, and Reports• Clinical Development PlansCost Optimization: Strategy review to reduce compliance execution costs through cross-disciplinary strategy development.Process Development and Project Management: Lead teams to achieve EU MDR compliance for medical device families with accelerated timelines. Develop/Review quality and business documents, including:• Standard Operating Procedures (SOPs), training and testing materials• Templates, Work Instructions• Statements of Work (SOWs), Requests of Proposals (RFPs)• Gnatt Charts, executive summaries, scorecards, and other project/ program management materials• Press releases, white papers, website content, and other marketing and sales materialsCommunication: Facilitate strategy communication to internal and external stakeholders, including notified bodies and auditors.

•Defined PMCF / Phase IV strategy aligned with business objectives and priorities for a portfolio of >80 medical device families; updated the previous strategy, reducing expected execution costs >100-fold, saving >$300MM.•Grew team from 1 to 6 contributors•Thoughtfully designed new processes/ SOPs, templates, PMCF Plans and PMCF studies in compliance with international regulations (e.g., EU MDR, ISO 14155, ICH E6)•Established collaborative cross-departmental relationships and stakeholder buy-in supporting CE-mark maintenance and business growth•Provide mentorship to junior and peer colleagues•Managed relationships with external contractors and CROs

•Head clinical scientist for post-market clinical research / Phase IV strategy for 23+ medical devices and solutions (EU MDR Class I, IIa, IIb, & III)•Secure cross-functional department alignment (commercial, marketing, regulatory, clinical, scientific, engineering) on medical device strategy and tactics supporting multiple business areas in a global setting•Design, conduct, analyze, and report on clinical research activities using real-world data•Develop, implement, and review processes and regulatory documents in compliance with EU MDR 2017/745 (E.G., PMCF, PMS, Clinical Evaluation, Systematic Literature Review, and Clinical Study Plans/Protocols & Reports)

Operations Leadership• Led process optimization, tool and personnel development for the Americas’ Market and Sales Development Team, doubling the top-line sales pipeline in <1 year from establishing the department.Market Development and Sales Excellence• Spearheaded market campaigns for conferences and events. Consistently performing ≥100% of quotas, resulting in >$7MM opportunities added to the sales pipeline.

• Construct and execute business development strategies for burgeoning startups in the tech and health tech industries• Create strategic development plans to build profitable business in existing and new markets• Train sales teams in effective client communication to close deals and increase market penetration

Discovery and Clinical Study Design and Execution• Responsible for biomarker study design, protocol development, study execution, data analysis, interpretation, and report generation for discovery research and clinical studies in muscular dystrophy, immuno-oncology, and other disease areas. Spearheaded Flagship’s first interactions with FDA and EMA in support of a client’s clinical study.Business Development• Collaborated with business development and marketing departments to develop strategies for business expansion into neuromuscular diseases. Developed blog and press release documents. Secured the single, highest valued project in Flagship history. Scientific Collaboration• Collaborated with clients and academic partners to develop joint publications, and poster presentations for scientific conferences. Internally collaborated on R&D projects for Flagship’s proprietary image analysis approaches and to develop image analysis process patents.

Project Management• Simultaneously managed multiple clinical pipeline projects, valued >$3MM. Project lead of multi-disciplinary teams comprised of pathologists, statisticians, image analysts, & histo-technicians to deliver biomarker solutions to pharma & biotech clients in all stages of drug development.Scientific Communication• Scientific liaison between scientific clients and operational stakeholders. Translate complex scientific study designs for discovery and clinical research into actionable operational workflows.

• Perform data mining and analysis, and internal research and development for Flagship’s proprietary image analysis approaches and diagnostic development efforts.• Design and manage GCP biomarker development studies for pharmaceutical companies to evaluate efficacy of cancer and muscular dystrophy therapeutics

• Consulting for the health care, biotech, pharma, and life science research industries• http://glg.it/life-science/

• Consulting for the health care, biotech, pharma, and life science research industries• http://www.guidepointglobal.com/services/

• Life science tutoring tailored to students' individual learning styles to promote understanding of core concepts, not just memorization of facts

• Developed a novel assay to measure skeletal muscle stem cell homeostasis• Optimized myofiber isolation from challenging muscle groups, including the diaphragm, extraocular, and tongue muscles

• Investigated RNA post-transcriptional regulation of stem cell mediated skeletal muscle regeneration• Examined skeletal muscle stem cell turnover in uninjured muscles• Performed bioinformatic analysis of skeletal muscle stem cell gene expression through aging and muscle injury• Mentored multiple undergraduate and graduate students in experimental design and techniques• Collaborated with a Computer Science graduate student to develop a machine learning algorithm for RNA binding protein target prediction• Developed multiple ImageJ macros, including automated four-color quantification of cultured cells and myofiber-associated satellite cells• Skilled in molecular biology, biochemistry, cellular, and microbiology techniques, including DNA & RNA isolation, PCR, qRT-PCR, Next-generation sequencing, flow cytometry, Western blotting, miRNA/siRNA, immunofluorescence, IHC, confocal microscopy, mouse husbandry, whole tissue extraction and processing, and cloning to develop cell-based assays

Introduction to Cellular and Molecular Biology (Lecture and Lab, Fall 2009)• Prepared and delivered lectures on biological concepts and laboratory techniques• Directed students in creating experimental research projects• Managed several laboratories consisting of 30 students each

Fundamentals of Human Genetics (Fall 2008)• Assisted teaching genetic concepts to over 100 undergraduate students • Facilitated hands-on learning in small groups of 5-10 students

• Developed a cell culture assay to examine the molecular mechanisms of mitochondrial fission and fusion using fluorescent microscopy

• Prepared standard solutions• Performed basic biochemical assays such as liquid chromatography and Bradford assays