Boston, Massachusetts, United States
I build the operational infrastructure that takes biotech companies from concept to clinic. As Co-Founder & COO of ABLi Therapeutics, I am currently designing and executing a global Phase 3 program for a disease-modifying Parkinson’s therapy — leading clinical operations, quality, data management, and manufacturing while driving capital formation with venture, family office, and strategic investors. Alongside that work, I take on selective fractional COO and SVP engagements with Series A/B life sciences companies that need senior development operations leadership without the full-time overhead. I’ve spent 20+ years building DevOps organizations across the U.S., Europe, and Australia. From first IND through global Phase 3, I bring that infrastructure-building depth to early-stage teams at the moment they need it most. Where I add the most value: • Standing up clinical operations, quality, data management, and program management functions from scratch • CRO/CDMO contracting and vendor governance, with experience on both the sponsor and the CDMO side of the relationship • Global trial execution and enrollment optimization • Regulatory strategy and IND execution • R&D budget management and capital-efficient development planning If you are a founder or investor with a portfolio company navigating their first IND, scaling into Phase 2/3, or building out a development operations team, I would welcome a conversation. 📧 [email protected]
Building ABLi’s global development operations from the ground up across clinical, quality, data management, and manufacturing while driving Series A/B fundraising with venture capital, family offices, and strategic investors. • Presented to venture capital, family offices, and strategic investors, driving capital formation to fund clinical programs and company build-out • Designed global Phase 3 program to provide registration ready data for disease modifying therapy in Parkinson’s • Constructed teams excelling in the areas of Clinical Operations, Quality Assurance, Data Management, and Manufacturing tasked with executing ABLi’s global development operations strategy • Negotiated $75M+ contracts with vendors supporting Global Phase 3 trials in Parkinson’s
I take on selective fractional COO and fractional SVP engagements with early-stage biotech and life sciences companies that are building their development operations infrastructure. Available to Series A/B biotech organizations that need senior development operations leadership across clinical operations, program management, CRO and CDMO governance, regulatory strategy, and organizational build-out without the full-time overhead. I engage as Fractional COO, SVP Development Operations, VP Clinical Operations, or Head of Development Operations depending on the organization’s structure and needs. The title is flexible, the depth of experience is not. Engagements are structured as monthly retainers or defined-scope contracts, typically two days per week. I take on one to two clients at a time alongside my operating role at ABLi Therapeutics. Areas of focus: Fractional COO · Fractional SVP · Development Operations · Clinical Operations · CRO Management · CDMO Management · IND Strategy · Phase 2/3 Execution · Regulatory Affairs · Program Management · Biotech Startups · Team Building · Clinical Scale
• Developed Inhibikase’s PAH clinical development strategy (indication positioning, target profile, endpoints, trial design, and regulatory pathway), establishing the investment thesis that supported a $275M institutional financing • Drove enterprise R&D operations in partnership with executive leadership by defining portfolio strategy, operating plans, budgets, and governance for Parkinson’s disease and PAH, while owning external execution through CRO/CDMO/site contracting and budget management to deliver against cost, quality, and timeline targets • Provided executive leadership and orchestrated execution across Clinical Operations, CMC/manufacturing, Quality, Program Management functions leading to the successful completion IKT-201 safety, tolerability, and preliminary efficacy study for risvodetinib • Implemented an innovative patient recruitment strategy that reduced enrollment timelines by ~4 months, and enabled real-time decision-making through automated dashboards/KPIs and an operational information marketplace
• Led end-to-end Program Management, Clinical Operations, CMC and Regulatory to define portfolio strategy and directed cross-functional execution across clinical development, manufacturing, analytical development, quality, and regulatory affairs, aligning timelines, resources, and risk management to deliver on company development strategy across Autism and Parkinson’s disease programs • Drove IND strategy and execution, administering regulatory filings and delivering the company’s first IND and first-in-company clinical trial, generating early proof-of-concept data supporting the scientific hypothesis • Owned external execution and spend: negotiated and managed CRO/CDMO/site contracts and budgets, led a 15-person global team, and optimized R&D burn by establishing Australian operations to leverage government R&D tax incentives • Promoted from Senior Director in 2019
• Deployed enterprise portfolio management system to drive optimization of Momenta’s product portfolio consisting of proprietary and generic products while executing strategic corporate initiatives by implementing program management processes and tools