Product commercialization, market access, payer reimbursement strategy, KOL / Medical Director engagement, account management, CLIA strategy, portfolio planning, channel partners, healthcare system contract and licensing negotiationhttps://www.dreambighealth.com/team-1/dr.-randy-e.-david

Establishing growth strategies, partnerships, and business opportunities for an algorithmic medicine company with a proprietary platform utilized for omics data management, early-detection diagnostic biomarker discovery and drug repurposing.

I am the sole proprietor of this strategy firm, advising pharma and biotech executives in the digital health/SaaS, and precision medicine (genomics, diagnostics, biotherapeutics) sectors regarding fundraising, product design (user experience / UX), value communication & frameworks, evidence generation planning, payer strategy, and market expansion, ensuring sound evidence-based decision-making.

• Headed Life Sciences vertical (and later Healthcare Systems vertical too), encompassing business development, cross-functional operations, account management, partnership building, and revenue generation. • Oversaw technical sales, sourcing leads, creating proposals, and negotiating complex contracts and licensing agreements.• Led team members utilizing management abilities to cultivate thought convening, collaboration, and cohesion to achieve operational and financial growth goals.• Directed client relationship management (CRM), reporting weekly on KPIs and other deliverables to C-suite executives. Regularly led client calls with regulators, payers, and professional organizations, and joined client R&D, Medical Affairs, and Commercialization team strategy meetings. • Championed process development, building an organization-wide core infrastructure of best practices that led to the creation of a suite of marketing collateral, a new virtual patient SaaS platform / app, sales lead pipeline, improved project KPI tracking, and the institution of new software to bolster market research, business analytics, and operational efficiencies.• Oversaw the strategic business plan for shepherding diverse medical products to market, creating unique, data-driven value stories by engaging healthcare system leaders, physician KOLs, and patient advocacy groups. Convened with regulators and payers as appropriate.• Designed and executed feasibility assessments, proof-of-concept projects, and clinical trial support within health systems, leading contracting, licensing of data, and publishing.

• Selected to lead (during the COVID-19 response) by serving as the primary advisor to and liaison between the Michigan Department of Health and Human Services, the Centers for Disease Control and Prevention (CDC), and the City of Detroit. Tripartite employment to increase cohesion.• Stewarded population health operations, process, and logistics (clinic standup and staffing, online registration databases, etc.) related to disease prevention, testing, and vaccine access, clinical outcomes, regulatory compliance, health equity, and public communications while leading a team of 135 staff.• Tracked the inventory of all administered and stockpiled vaccine doses and test results (COVID-19 and otherwise), working with the White House Coronavirus Response Coordinator and Pfizer, Moderna, Janssen, and others to ensure a steady access pipeline. Discussed trends with national CDC executives, neighboring states, hospital systems, research institutes, and other stakeholders.• Guided the creation of DUAs with the largest hospital systems in Michigan, private testing companies, county governments, and research institutions, to harmonize EHR and other data with different health IT systems.• Led the creation of infection prevention guidance and was final decision-maker for all official mitigation measures, working with legal counsel to craft policy. • Handled all internal and external data sets, disease reporting and online dashboards, ensuring data security and appropriate access to protected health information. • Responsible for the management of and reporting on a battery of federal, state, and private grants totaling over $50 mil.

• Headed an expansive project spanning numerous clinical sites and a suite of NIH healthcare grants, with responsibilities including operations management, supply chain, resource management, administrative functions, policy development, and team leadership.• Managed an extensive team of researchers and healthcare workers, recruiting, hiring, training, and guiding personnel to build a high-performance enterprise.• Directed the creation of processes and standard operating procedures (SOPs) for critical activities including data collection, and reporting to safeguard regulatory compliance. • Oversaw all fiscal activities including procurement, equipment purchase/maintenance, site leasing, and salaries, ensuring adherence to budgetary restraints.

• Applied research into real-world evidence (RWE) generation, molecular biomarkers and epidemiology, clinical outcomes data, health technology assessment (HTA), and the adoption and integration of healthcare technologies.

• Conducted research into molecular genomic biomarkers / analytes for disease and genetic architecture across diverse populations, with implications for the creation of life sciences products.