Clin Ops Masterclass: Michael Gold on Executing Excellence at Scale

I recently wrapped up my conversation with Michael Gold, Chief R&D Officer at Compass Pathways. He has 30 years of neuroscience R&D experience from J&J and GSK to sub-20 person biotechs. His operational philosophy prioritizes execution precision over design complexity.

Full video can be accessed here

The Quality-First Framework

Gold's hierarchy is non-negotiable: "Quality, time, cost – in that rank order." The counterintuitive insight: this becomes more critical at smaller biotechs, not less. "You don't have the resources to make up for mistakes, to do it again," he argues. His operational north star? "The best clinically designed clinical trial, if it's not executed correctly, is useless."

Protocol Design: Strategic Subtraction

Most teams overload protocols with "nice to have" endpoints. Gold's protocol review committee at GSK had one question: ‘What are you going to use this data for?’ If the answer wasn't compelling, it got cut.

"Every time you keep piling things on for participants, they get frustrated, they're fatigued." Patient fatigue translates directly to dropout rates and data quality issues. Gold advocates for the KISS principle… focused execution delivers cleaner answers.

Real-Time Data Vigilance

Gold's dream dashboard: patient pipeline flow, retention tracking, missing data patterns, and site activation timelines. Reality check: "We have a lot of it, but it's not frictionless to actually access."

On a related note, you can read about using heat maps to track site progress here.

Hard-learned lesson: a three-year time-to-event study that appeared futile actually had plenty of events sitting in investigator documents that never made it into the EDC system. "If you're blind to the data, I'm operating completely blindfolded."

Site Relationships: Service, Not Sales

Gold reframes the sponsor-site dynamic: "We're in the service of sites. If they're not happy, if they don't have what they need, they're not going to recruit the right patients."

His approach: "What do you need? Help with recruitment? More money? Staff support? Where can I block and tackle for you?"

Critical CRO insight: Gold negotiated team stability clauses after 100% monitor turnover every six months. His contractual ask: "I will take the B and C players. I will whip them into shape, but you don't get to move them around."

Regulatory Reality Check

Gold's underrated take: "What is overrated is people's fear of the FDA." He views regulators as having the broadest industry perspective. "If there's an oracle that can share wisdom, it's regulatory bodies."

Bottom line: In psychedelics' first-in-class territory, Gold's betting on operational excellence over innovation theatrics. At Compass, that philosophy is scaling COMP360 through Phase 3 with 30 years of hard-won operational discipline.

-Brandon (Co-Founder @ Power)