Our Services
At the intersection of science, strategy, and execution, I offer comprehensive consulting services to help biotech teams bring innovative therapies to life—smarter and faster. From early-stage drug development and IND planning to clinical trial operations, regulatory strategy, and stakeholder engagement, I partner with companies to optimize every phase of the development process. Whether you need guidance on CRO selection, trial budgeting, FDA interactions, or building strategic partnerships, I provide the expertise and hands-on support to accelerate progress and deliver results.
Drug Development Strategy
From concept to clinic with clarity
Strategic planning across preclinical and clinical development
IND preparation and regulatory roadmap design
Phase I–II trial design support
Portfolio prioritization and go-to-market strategy
Clinical Operations & Trial Execution
Efficient trials start with smart planning.
Trial startup and execution strategy
CRO identification, contracting, and oversight
Site selection, activation, and performance support
Central IRB and decentralized trial planning
Contracting & Budget Management
Aligning science with smart spending
Trial budget development and financial forecasting
Contract negotiation with CROs, vendors, and clinical sites
Oversight of multi-million-dollar R&D budgets
Regulatory & Compliance Advisory
Navigating the regulatory landscape with confidence.
Regulatory strategy and FDA communications
IND submissions and briefing package preparation
SOP and policy development for trial compliance
GCP readiness and audit preparation
Data-Driven Trial Optimization
Using data to unlock efficiency and insight.
Trial performance dashboards and analytics
Risk-based monitoring strategies
Patient recruitment and retention optimization
Database lock and data review planning
Scientific Leadership & Innovation
Empowering teams, advancing therapies.
Cross-functional team coaching and project leadership
Translating business goals into scientific action
Grant writing, scientific review, and protocol consultation
Patient-centered trial design and equity-focused strategy
Contact Me
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