Reopened the firm in 2024 during job search. Established consulting company in 2012, providing support for marketing, clinical development, corporate management, clinical operations, project management for large and small pharmaceutical companies, • Supported large CRO with process improvement for future restructuring and clinical operations changes to support new adaptive monitoring approach and development of in-stream data review• Provided strategic and tactical research and development support, regulatory affairs leadership and sales / marketing support for diet supplement company; led major IND submission for drug status, served as Director of Regulatory Affairs

Support non-profit organization dedicated to providing leadership training to pharmacists and pharmacy students as a non-compensated volunteer. Responsible for Executive Leadership including organizational management, management of operations and volunteer Board of Directors. Also served as CFO and managed accounting, financial planning and execution of financial operations.

Led functional operations engaging cross-functional and cross-divisional teams for technology and innovation in development in the Global Development Operations (GDO) group.• Served as the Chief of Staff / Head of Operations to 6 different department Vice Presidents and managed greater than $3-plus million annual budgets.• Managed all aspects of the function, including agenda/minutes for Leadership Team, managed Town Halls, provided functional budget management, resource allocation across projects, human resource activities, including onboarding/offboarding and training.• Spearheaded projects that included organizational design, process improvement, technology adoption, cultural change management, and portfolio management• Acted as the GDO Lead on Business Information Security, led GDO China Cybersecurity Law implementation, managed a development footprint project, and a regulatory submission process and technology improvement project.• Organized and led monthly GDO Symposium, where speakers updated over 400 people monthly on new projects or technology implementation.

Led project management / operations office engaging cross functional and cross divisional teams for innovation across clinical operations.• Led cross-functional operational excellence Portfolio Review Board, managing all clinical operations project portfolio, allocation of resources and prioritization.• Implemented Innovation Council, created innovation ideation tool and process for grass roots innovation, led focused innovation project leading to five (5) funded innovation projects.• Created SharePoint Innovation Suite - collecting project information, innovation vendors, users and communication sharing.• Managed all aspects of the function, including agenda/minutes for Leadership Team, Town Halls, budget management, resource allocation across projects, human resource activities, including onboarding/offboarding and training

Led the functional and operational activities effectively by actively driving the development, implementation and execution of organizational strategies, policies and business practices and ensuring optimal processes and resource utilization across department. • Served as the acting Head, Project Management Office, leading a team of 10 Project Managers in cross-functional process improvement, resource management, and metrics / prioritization decision management. • Accountable for the integration, planning and management of functional and operational activities across the Process and Technology Optimization group to ensure organizational effectiveness of internal operations as well as external deliverables and act as primary liaison with other Global Drug Development (GDD) operational functions.• Managed all aspects of the function, including agenda/minutes for Leadership Team, managed Town Halls, provided functional budget management, resource allocation across projects, human resource activities, including onboarding/offboarding and training.

Led all aspects of operational and strategic delivery for portfolio of analytics development programs for two franchises including over 50 compounds and all phases of development, from first in man through to post-marketing. Provided strategic cross-functional operational leadership related to the sourcing and alignment of analytics operational plans. Provided organizational leadership through matrix-management of Franchise-aligned group of senior functional leaders (Franchise Leaders in Data Management, Biostatistics, Statistical Programming, Data Standards, Medical Writing, Clinical Submissions, Global Clinical Operations) responsible for 150-250 matrix associates, while functionally managing a team of 3 Analytics Project Managers and Senior Project Managers (Director level). Served on Franchise Operations and Clinical Operations Boards. Established PM center of excellence and led PM training.• Led cross-functional analytics coordination for Entresto PARADIGM outcomes trial for early close-out after successful early study stop due to efficacy; met stretch targets to deliver Heart Failure study with over 8000 subjects.• Developed new Franchise cross-functional reporting tool, including coordinated risk planning, resource management analysis, and escalation processes, and chaired Analytics Franchise Leadership Team.• Established a SWAT Team concept for pre-Database Lock concentrated teams for key large outcomes trials.• Created a Cross-functional Issues Tool (CFIT) for all development associates to allow reporting of process improvement, and study/program issues to a central online tool for quick resolution and tracking.• Led Metrics in the development of online tool. Led Communication / Change management sub-teams and served on Core.• Established a Lessons Learned process, including templates and meeting materials for turn-key implementation.• Led Portfolio Governance Workstream for establishing a cross-functional portfolio evaluation / reporting process.

Non-salary equity role providing part time operational support to start-up pharmaceutical company, specializing in delta agonist development; provided Project Management and Quality Assurance functional support to pre-clinical project and management teams including Board of Directors

Responsible for leading Translational activites (pre-IND to Phase 2) Project Management, Clnical Trial Management and QA/QC groups, in addition to functional role, served as Project Manager and Global Project Leader of some compounds. Developed Due Diligence and BD&L processes for out licensing

Created Project Management department; eventually promoted to manage both Project management and Clinical Operations. Renamed group to Clinical and Project Management Department.

Led team of 11 professionals: 2 Medical Directors, 6 managers, one medical marketing coordinator and 2 administrators. Managed a $25 million (then €20 million) budget. Managed all respiratory products and created and formalized the first Medical Affairs department for the company.• Responsible for leadership of Global Medical Affairs for all respiratory products, project management for Phase 3b/4 publications, professional affairs, Key Opinion Leader management, congress communications, and medical copy review. Supported health economic, pricing/reimbursement planning teams with medical support• Developed strategic clinical plans for Alvesco®/ciclesonide, an Inhaled Corticosteroid (ICS) for asthma, and Daxas®/roflumilast, a Phosphodiesterase - 4 Inhibitor, for COPD/asthma• Developed and submitted more than 80 abstracts; 21 publications plus one supplement in 2004 • Participated on Disease Area Strategy Teams for asthma, COPD, and rhinitis, reviewing early development and in license strategy, participated in go/no go decision making

Directed a team of six professionals responsible for managing the pricing, reimbursement and health outcomes strategy for Pharmacia’s primary care and specialty products. Managed department within a cross-functional matrix environment. Promoted four times during 3+ years at Pharmacia.• Created new position combining pricing and health outcomes strategy into marketing strategy post-Monsanto/Searle merger• Led nine cross-functional Economic Strategy Teams to develop and implement global (US and non-US) pricing, reimbursement and health economic/outcomes research strategy and tactics for marketed and development products. (Total sales of portfolio in 2001 at $3.8B)• Developed and implemented economic strategy plans (including pricing, reimbursement and health outcomes plans) for twelve products in 9 therapeutics areas• Reviewed all primary care and specialty in-license opportunities and provided strategic leadership on internal R&D pipeline products, including roflumilast/Daxas® (ALTANA)• Managed Cardiovascular, CNS, Metabolic, Respiratory, Urology, Women’s Health, Ophthalmology, Neurology, and Endocrinology products (eight in-market and ten pipeline) • Successfully leveraged and managed multi-million dollar pricing and economic budgets• Led Pharmacia - ALTANA joint economic strategy team within Joint Marketing Alliance• Served on several senior management teams for strategic planning, organizational transitions• Developed economic strategy for a development compound that increased profit > $1.5B

Developed and directed a strategy, training, and communication planning consulting practice, providing services to the managed care and pharmaceutical industries. • Created new consulting practice; developed department, function, priorities and budget• Clients included major pharmaceutical industry outcomes and marketing groups (non-confidential client list available by request)• Provided health economic strategic planning and marketing communication services in the following therapeutics areas: overactive bladder, depression, diabetes, cardiovascular diseases (hyperlipidemia, CHF, hypertension), and schizophrenia• Provided strategic input for clients evaluating projects in early development and discovery for in-license and go/no go decision making• Delivered over $2 million in new business opportunities in 12 months • Developed and implemented all new sales materials, internet site, client marketing program and client management system• Presented and published client clinical and economic data at congresses and in manuscripts• Participated in client advisory boards and medical education programs as speaker

Directed all US outcomes research, market access, economic analyses, and disease management initiatives in cardiovascular, pulmonary, and diabetes therapeutic areas for US market.• Created new department, procedures, policies and priorities after CIBA/Sandoz merger• Managed staff of five Outcomes Research Managers, Pharmacoeconomic research fellows• Managed multi-million dollar project budget, managed over 100 projects and publications• Developed economic strategic planning, disease management and managed care strategy for key cardiovascular products (Diovan®, Lescol®, Lotrel®, Lotensin®, DynaCirc®)• Served as acting Global Director for Cardiovascular Outcomes Research for 6 months• Developed award-winning Lescol®/Lipitor® two product formulary strategy for managed care• Led a 22 city medical education program for Lescol®, defending market share loss to Lipitor® by 20%• Developed and managed DIOQOL Study, observational trial for Diovan launch

Managed multi-site research project designed to measure the effect of disease management and training for pharmacists to provide pharmaceutical care for patients with asthma and hypertension. Responsible for five member staff, communications to ten faculty members, 28 pharmacists and over 600 patients. Responsible for data and project management, and conducted data analysis with statistical consultants.