Programme Leadership & Biopharma Operations 

Setting up clear stage-gate frameworks and institutional-grade programme management from day one.

Cross-Functional Alignment: Directing integrated development teams across non-clinical safety, CMC, regulatory, and early clinical development.   

Stage-Gate Discipline: Enforcing unambiguous go/no-go decision gates to de-risk assets before committing major capital tranches.

Board & Investor Reporting: Delivering transparent, defensible development dashboards that give boards and steering committees total clarity on burn rates, critical paths, and milestone schedules.

Running agile, capital-efficient programmes through elite external networks rather than permanent internal headcount.

Partner Procurement & Oversight: Leading commercial negotiations, performance management, and day-to-day oversight of tier-one CDMOs and specialist CROs.   

Lean Special Purpose Vehicles (SPVs): Architecting asset-centric operational models that protect the balance sheet and preserve founder equity.   

Infrastructure Integration: Leveraging national clinical hubs and networks—including UK NIHR Biomedical Research Centres—to compress setup timelines and access key opinion leaders.

Integrating every development plan from the target product profile (TPP) to ensure clinical and commercial viability.

Reimbursement by Design: Ensuring molecules are engineered to satisfy stringent health technology assessment (HTA) and payer criteria, avoiding scientifically elegant but unviable products.   

Modern Clinical Protocols: Deploying innovative trial architectures, including Bayesian augmented-control models and synthetic data assets, to reduce patient burden and trial duration.   

Regulatory Navigation: Designing early regulatory dialogue and CTA/IND-enabling packages (MHRA, EMA, FDA) that accelerate first-in-human milestones. 

High-level operational leadership for emerging biotechs building out their development infrastructure and managing cash burn.

End-to-end accountability for leading a designated asset through preclinical candidate nomination, CTA/IND submission, and Phase I/II clinical readouts.

Diagnostic board-level audits of active programmes, identifying critical path risks, vendor friction, and governance gaps ahead of funding rounds.