Most governance is well attended, well prepared, and not deciding anything.
Six places governance stops deciding
Development programme leadershipGlobal programme management across neuroscience, oncology and rare disease, spanning Phase II, Phase III and regulatory submission — including as Global Program Manager for a filing.
Governance designStructuring the forums that decide, so that the discussion happens where the decision actually gets made rather than where it is most comfortable to argue.
Decision frameworks embedded, not presentedI contributed to embedding a Probability of Success framework into programme management governance at Novartis. The difficulty is never the framework; it is making a governance body use it under time pressure.
Cross-functional alignmentWorking across clinical development, regulatory affairs, biostatistics, patient safety, commercial and market access — functions with genuinely different incentives and vocabularies.
Budget and portfolio accountabilityProgramme budgets, timelines and the investment decisions attached to them.
Enterprise platform adoptionDriving uptake of a multimodal analytics platform across an entire drug development organisation, from early clinical through Phase IV and post-marketing safety.
I have held all three of the jobs this work touches
Ten years at Novartis and Sandoz, moving from statistical execution to scientific judgement to programme accountability. Quantitative safety science, forming and defending positions on individual compounds. Then global programme leadership with budget, timelines and governance. Then enterprise data platform adoption across the development organisation.
The through-line is that I have been the person doing the analysis, the person accountable for the programme, and the person trying to get an organisation to adopt something new. Those are three very different jobs, and most advice comes from people who have only held one.
This fits four situations, and three it does not
A good fit
You are scaling from early phase into late-phase development
Your governance meets often and decides rarely
You are preparing a first regulatory filing without having done one
You have a decision framework nobody uses under pressure
Not a fit
You want interim staffing of a programme management office
You want operational trial execution or vendor management
You want a governance structure documented but not changed