Senior scientific executive overseeing the clinical development and post-marketing medical affairs support of a novel AI/ML-powered skin cancer detection device for healthcare providers and patients. Responsible for all aspects of designing and managing studies supporting enhanced labeling, meeting post marketing requirement, RWE generation and independent investigations, as well as KOL development, MSL support, publication and presentation planning, scientific exchange, advisory board management, medical education and communications, and providing tools and services supporting the successful introduction of a hand-held, FDA-cleared POC tool providing immediate results to assist physicians with clinical decision making and triage of potentially malignant skin lesions.

Provides strategic clinical guidance to executive team while overseeing all aspects of clinical development and operations, medical affairs and drug safety focusing on novel delivery of neurology and immunology products. Work collaboratively with CEO and other functional heads to define and support formulation design, development, regulatory submission, commercialization, external communications and and business development. Serves as scientific face to regulators, investigators, analysts, Scientific Advisory Board members, and end users.• Lead Phase I-III protocols, analyze and generate data of for regulatory submission of NDAs for a epilepsy treatment; guide responses to information requests; produce posters, abstracts and manuscripts• Support commercialized CNS therapeutic area products in ALS, LGS, and pain management, including clinical and safety oversight and participation in licensing discussions.• Lead clinical development of novel epinephrine delivery system for anaphylaxis through IND, PK studies and later phase pivotal trial.• Stand up and execute new Medical Affairs capability, including MSLs, scientific platform and publication planning, KOL development, and scientific exchanges at conferences • Oversee Drug Safety medical monitoring and annual reporting for both clinical development studies and post-marketing surveillance.• Advance company’s clinical development capabilities with enhanced internal clinical expertise, data management capabilities, and interactions with CRO service providers • Established SOPs for the Medical/Marketing interface to ensure compliant interactions• Represent scientific/medical information at advisory boards, Board meetings, earnings calls, analyst meetings, medical conferences, business development partner meetings.• Provided medical review and due diligence of various business development and licensing projects

Lead and support colleagues within the Office of Medication Error Prevention and Risk Management (OMEPRM) and other FDA Offices in setting policies, developing guidances and conducting reviews of proposed Risk Evaluation and Mitigation Strategies (REMS) and medication packaging/tradename submissions; reviewing REMS assessments and proposing modifications to REMS programs; supporting human factors studies; and representing OMEPRM within CDER, across FDA, and at external public and Advisory Committee meetings.• Led and supported the FDA Office responsible for review, approval and assessment of all REMS program submissions across all therapeutic areas, as well as medication tradename reviews• Managed over 80 staff, conducted Office-level review and sign-off, and served as Acting Director, Office of Surveillance and Epidemiology addressing various emergent safety issues• Represented the Office in cross divisional meetings with staff from Office of New Drugs, Office of Center Director, Office of Regulatory Policy and Office of General Counsel• Led internal cross-divisional initiatives developing REMS policies, guidances and white papers for standardizing REMS, including benefit-risk counseling and use of CME elements• Participated in multiple public and Advisory Committee meetings related to products with risks that warranted REMS, REMS assessment guidance, REMS policies, and the packaging/storage of opioids

Principal responsible for leading the design, development and implementation of risk management programs and process of care improvement programs and providing strategic consulting to numerous pharmaceutical and biotechnology clients. Care improvement and risk management programs spanned all therapeutic areas. Leads strategic and technical consultation, client consultation/management and project delivery.• Co-founded ParagonRx (www.paragonrx.com) business and co-led consultancy to support the appropriate prescribing and safe use• Thought leader advancing a new approach to designing pharmaceutical safety risk analysis, evaluation and risk management programs by adapting a evidence based risk evaluation and management methodology into RxFMEA. Authored two leading textbooks and served as a frequent presenter at conferences, webinars, and FDA public meetings• Executed ethnographic “caremapping” of the medical care delivery process from diagnosis through follow-up to both define expert practices and identify how to mitigate process gaps • Led successful consultation and delivery of over 80 risk management, RiskMAP and REMS programs, ranging from program design through documentation, implementation and assessment• Co-developed a new risk evaluation, program design and tracking method executed on a program design software platform• Supported business transformation from a start-up business through expansion and ultimate acquisition by a larger firm. Actively involved in strategic business decisions, redesign of company processes and systems, strategic alliance negotiations, marketing support, employee recruitment and personnel management• Focused on continuously improving management service solutions to address evolving and more proactive drug safety regulations and the resulting compliance needs of various pharmaceutical company clients, balancing improved product utilization with reduced safety risks

Senior executive responsible for leading strategy and operations of a healthcare management services and solutions enterprise. These programs and services guided more standardized, higher quality healthcare delivery and pharmaceutical product use by health plans and employers. Responsible for all direction setting, decision-making, organizational leadership, budgetary and personnel management. Major accomplishments: • Led 80+ person division in the design and dissemination therapeutic care management programs in asthma, migraine, influenza, smoking cessation, HIV, and others• Improved health plan ranking of GSK’s offerings among health plans from 47th to 3rd in less than 3 years.• Built and commercialized a suite of service line-extensions, including program templates, actuarial models and customer-based product value studies. • Designed studies and models demonstrating the value of GSK products instead of more expensive medical services, including cost savings, improved quality and greater productivity• Led execution of two field sales forces for health plans and employers to drive program adoption and product use, retain formulary position, and mitigate rebates.• Created strong internal and external demand for services, receiving a top-10 client valuation rating on sequential HIRC surveys over several years. Awarded “Best Pharmaceutical Program” by Disease Management Association of America over 2 consecutive years• Established metrics for tracking and reporting the value of programs and services to both external customers and internal stakeholders• Improved operational performance metrics despite budget and staffing reductions through reduced program development time, shortened sales cycle time, web-based versions enabling rapid revisions and reduced inventory costs, and placement of multiple programs in individual accounts

Senior medical officer of a leading disease management services subsidiary providing strategic medical and business support for the development, implementation and enhancement of disease state management products, programs and services for managed care customers. Designed and implemented a CHF telemanagement program for health plans designed to reduce early re-hospitalization rates.• Established and led a new Medical Services division, then successfully managed integration of a New Program Development section• Conceptualized, developed, implemented and managed a nursed-based outbound telemanagement service that reduced early readmission of at risk heart failure patients • Established health outcomes function, designed protocol to demonstrate impact of heart failure program on quality, cost and process outcomes, with a 65% reduction in readmissions• Supported information management group in developing longitudinal patient record and database; established algorithms for identifying and segmenting patient populations and protocols for measuring and reporting intervention impact• Conducted numerous assessments of outside technologies, new business development opportunities and drove exploration of several strategic alliances

Senior executive building and leading newly established department within Clinical Development responsible for the delivery of clinical study findings to support the approval and commercialization of new pharmaceutical products, while building a collaborative relationship with the company’s Commercial function. Major accomplishments:• Established, organized and led a new department of 50 scientific staff and a $13 million annual operating budget, achieving a series of successful development and regulatory milestones• Established highly collaborative relationship with Commercial functions and strengthened commercial/clinical interface • Responsible for overseeing drug safety function as well as conduct of numerous Phase IIIB/IV studies in multiple therapeutic areas: anesthesia, anti-psychotic, CV and oncology