Head of Evidence

Healthcare systems must shift towards proactive care: early detection, prevention, better outcomes with fewer resources. We have real-time access to data across millions of patients. That unlocks evidence generation that was previously theoretical: continuous PMS/PMCF, robust health economics, value-based pricing. We are the only multimodal Class IIb certified AI Clinical Decision Support tool (EU:MDR), with deep EPR integration partnerships enabling rapid scale across hundreds of hospitals.

About The Role

You own everything evidence-related at Sanome. The RCT proving product impact. The PMS framework monitoring performance. Our real-world evidence platform, Sentinel, that ties it all together. You will design it, build it, and operate it as a continuous evidence engine across every site and product we deploy. Most healthcare evidence is retrospective, slow, and constrained by what data you can get hold of after the fact. We have something different: real-time access to live patient data across millions of patients, across multiple hospital sites. An evidence generation dream. The kind of access that makes things possible that before seemed theoretical or impossible. We need someone who sees that and gets excited, someone who wants to challenge legacy approaches and push the boundaries of what continuous, real-time data can achieve.

You will translate what Sentinel produces into peer‑reviewed publications, conference presentations, regulatory submissions, and the evidence packages that regulators, payers, and pharma partners need to say yes. You are Sanome’s evidence voice. You will work alongside a project manager, clinical deployment lead, data science and ML team, QARA lead, external regulatory consultancy, and comms agency. You bring the thread that connects them: a single, coherent evidence strategy that delivers across every audience. This is hands‑on. The person designing the PMCF protocol on Monday is translating evidence into commercial language on Wednesday and presenting to a pharma partner on Friday. If that excites you, keep reading.

What You’ll Do

• Evidence Generation: Design, Build, Operate
• Own real‑world observational evidence generated continuously through Sentinel
• Design and deliver the full RCT lifecycle from protocol through to final study report
• Own post‑market clinical evidence (PMCF/PMS) across all deployed products
• Own qualitative and adoption evidence: case studies, clinician testimonials, co‑design outputs
• Accountable for CER, periodic safety updates, CIP, SAP for clinical and health economic endpoints, PMCF plans and reports, AE/SAE reporting per MEDDEV 2.7/3, EU MDR Article 80 and internal QMS procedures

• Regulatory Evidence Support
• Own clinical evidence inputs into all regulatory submissions and scientific advice briefings
• Present the clinical picture to Notified Bodies, MHRA, and FDA
• You own the evidence; our QARA lead owns the quality system

• Evidence Communication and External Credibility
• Own peer‑reviewed manuscripts from draft to acceptance for clinical, RWE, and health economic publications
• Own conference abstracts, presentations, and podium appearances
• Write NHS procurement case studies: clinical impact, economic, and adoption narratives
• Drive the evidence gap analysis toward NICE EVA inclusion
• Ensure evidence outputs are sequenced to commercial milestones, not just publication cycles
• Algorithm validation and ML methodology publications sit with the technical team

• Pharma and Life Sciences Evidence Support
• Build RWE packages for pharma partners across market access, trial recruitment, and real‑world outcomes
• You provide the evidence architecture; our pharma lead manages the commercial relationship

• SaMD Factory Evidence Architecture
• Build a repeatable evidence framework that scales across new indications, sites, and geographies
• Own the evidence architecture as a product: designed, maintained, and continuously improved

Requirements

You must apply if:

• Have 5+ years leading evidence generation or RWE in clinical AI or digital health
• Have designed and delivered at least one clinical investigation end to end
• Have written or contributed materially to CERs under MEDDEV 2.7/1 Rev 4 or EU MDR Annex XIV
• Can design continuous evidence generation frameworks, not just one‑off studies
• Can hold your own in a Notified Body Q&A, MHRA scientific advice session, or pharma evidence review
• Are comfortable translating ML/AI performance data into regulatory evidence
• Combine scientific rigour with pragmatism, clear communication, and a love of early‑stage execution

Bonus Points

• Direct SaMD or digital health product experience
• Pharma RWE, trial feasibility, or post‑market evidence partnerships
• NHS clinical environments and hospital data flows from the inside
• Notified Body liaison for EU MDR or FDA device authorisation
• NICE EVA, NIHR, or academic clinical trial infrastructure
• HEOR gets you excited and you want to start tomorrow

Why this role, Why now

MEMORI is CE‑marked, deployed into NHS trusts, and generating real clinical data. The RCT is underway, pharma partners are engaged, and the SaMD Factory vision means the evidence challenge will only grow. We need someone who builds the evidence engine that scales across every product, site, and market we enter. This may well be the defining moment of your career. In 5 years, others will say “I wish I had joined then”.

Benefits

At Sanome, we offer a market‑rate salary alongside progressive company benefits such as EMI share options, flexible working, private healthcare, team events, etc. However, the real reason you want to work here is to make a difference and be part of something that will positively impact millions of people worldwide.