Clinical Operations Specialist

32Co

01Health is at an inflection point. The platform is built, revenue is accelerating, and we are moving from a single-specialty company to a multi-vertical specialist healthcare platform - with AI as embedded clinical infrastructure. Our vision is to help all clinicians deliver the latest innovations in healthcare, improving the standard of care for millions of people.  Backed by the investors behind Revolut, CityMapper, and Depop - we're scaling fast across the UK and beyond, and are looking for exceptional people to join us on our mission.  What is happening at 01Health right now: Balderton-backed Series A company 90% of UK patients can reach an 01Health–affiliated clinic within 30 minutes All growth has been inbound, ~50% word of mouth 4.98★ customer rating from the dentists who use us Aerox (sleep) ready for national rollout to top-performing 01 Partners, with a 300+ clinic waitlist US expansion live  New verticals being tested and prototyped We are not searching for product–market fit anymore. We are ready to dominate the market, and to do it across multiple medical specialties, transforming lives in the process. The Role: We're hiring for one of the most critical and exciting roles at 01Health.   As Head of Operations, you will report directly to the COO and own day-to-day operations, leading a team of 50+ people across clinical, support, treatment planning, supply chain, fulfilment, and specialist teams. You’ll play a crucial part in enabling our geographical (US) and product (Sleep) expansion. How we deliver the next 10x growth has AI at its core. Working with our COO and leadership team, your job is to take those plans and translate them into crisp, well-run execution on the ground - and to be the feedback loop back up: surfacing problems early, spotting where reality is diverging from the plan, and channelling ideas and intel from team leads back into leadership decisions. Operations is already performing strongly. We’re not hiring someone just to keep the lights on; we’re also looking for someone to play a key part in redesigning and scaling how operations works. What you'll do: Own and run day-to-day operations across our Orthodontic and Sleep products (UK and US), with full accountability for our high quality bar, performance, and output against agreed targets. Execute against the operations roadmap set by leadership. Break it down into clear workstreams, sequence the work, drive it through to completion, and report progress crisply. Manage and develop team leads across functions. Set clear expectations, hold a high bar on performance, and run a tight operating cadence (1:1s, weekly reviews, monthly business reviews). Hit SLAs and performance targets consistently. Track the numbers, understand why they are what they are, and act fast when they slip. Identify and unblock bottlenecks. Spot where work is getting stuck, get to the root cause, and fix it - whether that's a process change, a tooling tweak, or a difficult conversation. Treat operations as a product. Design, build, and continuously improve internal tools, workflows and systems. Drive adoption and impact of AI and automation across your teams. The COO and leadership team sets the AI build agenda; you make sure the tools land, get used, and translate into measurable change in how operations actually runs. Run capacity planning, forecasting, and resourcing across your three areas, partnering with leadership on hiring and headcount. Lead operational readiness for new markets and products, executing the rollout plan and surfacing what needs to change as you go. Manage day-to-day supplier and partner relationships across our manufacturers and product lines, with clear ownership of lead times, quality, and fulfilment reliability. What success looks like: Operations runs smoothly day-to-day without needing COO involvement in execution. SLAs and performance targets are consistently met across the three areas as volume scales. AI and automation tools the team is building are actually adopted, used well, and driving measurable improvement in throughput and quality. Team leads have a clear, supportive manager who holds them to a high standard - and they're getting better at their jobs because of it. Leadership has full, accurate visibility into what's happening on the ground: nothing is festering quietly, surprises are rare, problems are caught early. Roadmap items land on time, in scope, and with the team leads bought in. You're seen as the trusted operator the COO can hand a problem or a plan to and trust will get done well. You'll thrive in this role if… You have 5-8 years of experience, for example combining top-tier consulting or finance experience with at least one operations role in a high-growth environment. You are obsessive about execution and detail. You take pride in things being done well, on time, and to a high standard - not just done. You are hard-working and high-output. You don't need to be told twice, you don't drop balls, and you bring real energy and pace to the work. You're a natural project manager. You can take a messy goal, break it into a clear plan, run it, and report on it crisply. You're great with people. You can manage and develop team leads, hold a firm line on standards, and have hard conversations when needed. You're an excellent communicator - clear, concise, structured - and just as comfortable writing a sharp update to the leadership team as you are sitting next to a team lead unpicking a workflow. You operate well with ambiguity but you bring structure to it: you turn vague briefs into clear plans rather than waiting for clarity. You are AI-fluent and genuinely excited to drive AI adoption across your teams. You don't need to be the one building the tools, but you need to be a power user, a strong advocate, and the person who makes sure they actually land in the real workflow. You are commercially minded. You understand why operational metrics matter to the broader business and you make trade-offs accordingly. Why this role: You'll be the senior operations executor at a fast-scaling company, reporting directly to the COO with a clear seat at the table. You'll own day-to-day operations across three exciting frontiers from day one: our core business, our growing US operation, and our new Sleep product line. Few mid-level ops roles offer that kind of breadth and frontier exposure. You'll have a clear scope and a clear mandate: take strategy from leadership and turn it into excellent execution. No fuzzy lines. You'll work side-by-side with leadership and have real exposure to how a high-growth company is run from the top. AI is reshaping operations and you'll be on the front foot, driving adoption of tools and ways of working that will define how operations is run for the next decade. Clear path to grow as the company grows - whether that's deepening into Director-level ownership, scaling into new markets, or moving sideways into other parts of the business. Compensation is benchmarked to senior mid-level operator roles in the London market, with meaningful equity.

Delfa

ABOUT DELFA Billions of people still suffer from every-day diseases. One key reason? Clinical trials are broken. Despite $120 billion spent each year, most trials are delayed due to bottlenecks like patient recruitment. Delfa is fixing this with autonomous AI agents. We're building AI agents to automate clinical trials. In less than a year from launch we’ve already: * Deployed onto 300+ trials across multiple conditions * Reached seven figures in ARR, growing 25% MoM * Raised an oversubscribed $3.8m seed from tier-one AI investors WHAT YOU'LL DO You’ll help design, review, test, and continuously improve the AI agents that interact with patients and support clinical trial sites every day. This role sits at the intersection of clinical operations, AI agent design, quality assurance, and customer delivery. You’ll use AI tools extensively, but your judgment, attention to detail, and ability to spot issues will be what makes the work reliable. You will: * Use Delfa’s AI workflows to extract inclusion/exclusion criteria from clinical study protocols, then manually review and refine the outputs for accuracy * Turn clinical eligibility criteria into clear, patient-friendly screening questions suitable for voice and SMS agents * Create and review voice agent reports that describe the agent’s screening logic, conversation flow, escalation rules, and operational setup * Support script creation for IRB/ethics submissions, adapting agent scripts to customer templates while preserving clinical and operational accuracy * Assist with AI agent management, including manual patches and configuration updates where API-based changes are not yet suitable * Sample real calls and patient interactions to identify issues, test fixes, and add recurring items to the monitoring list to inform future automated QA * Support pre-release testing of AI agents before they go live with patients * Once comfortable, design new AI agents end-to-end, which will then be reviewed and tested by senior team members * Work closely with product, engineering, and customer-facing teams to ensure agents are safe, accurate, and operationally useful for clinical research sites YOU'LL BE A GREAT FIT IF… You have attention to detail. You’re comfortable reviewing dense clinical or operational documents and can spot when something is missing, unclear, or inconsistent. You are comfortable using AI tools. You don’t need to be an engineer, but you should be excited to use prompts, structured workflows, and internal tools to produce high-quality work faster. You are clinically or scientifically literate. Experience with clinical trials, healthcare, life sciences, medicine, nursing, pharmacy, psychology, or biomedical sciences would be valuable. You care about quality. Our agents interact with real patients and support real clinical trials, so accuracy matters. You take pride in work that is careful, clear, and reliable. You can move quickly without being careless. Delfa is growing fast, and we need people who can learn quickly, make good judgments, and improve the process as they go. You have an ownership mindset. When you notice something is broken, unclear, or inefficient, you don’t just flag it, you help fix it. You communicate clearly. You can explain complex clinical or operational logic in simple, structured language that customers, internal teams, and AI agents can all understand. Nice to have: * Experience in clinical trials, patient recruitment, site operations, IRB/ethics submissions, or healthcare operations * Familiarity with inclusion/exclusion criteria, study protocols, or prescreening workflows * Experience in QA, call review, operations, or process improvement * Comfort working with structured documents, spreadsheets, or configuration tools LIFE AT DELFA Delfa is building a generational company to transform the way medications reach millions of patients in need. This is your opportunity to get in on the ground floor and work alongside the highest talent density team in the space, onsite at our London office 5 days a week: * A wine-snob who built foundation models at Roche at ETH Zurich * A former hedge fund trader with world class causal AI knowledge * A medical doctor turned AI engineer who builds prototypes on the weekend for fun * A ginger bloke who deployed production AI for J&J, Medtronic, and Exscientia WHAT WE OFFER * Competitive salary * 25 days’ holiday + UK public holidays * Modern office space 5 mins from Old Street station * True 0 → 1 ownership. You’ll take responsibility for work that helps clinical trial sites reach patients faster and get new treatments to market sooner. OUR HIRING PROCESS We work to get you an offer within a week with the following lean process: Intro chat with Gustav (CTO) and Jenna (Medical Officer) - 30 mins: An informal discussion about your experience, values, and career goals, and a chance for you to get a sense of the role and the team. Practical Challenge - 90 mins: No artificial interview questions. Instead, you’ll work through a real-world task similar to the work you’d do at Delfa, such as reviewing eligibility criteria, improving screening questions, or identifying issues in an AI agent flow. You are welcome to use AI tools. Offer. If all of the above goes well, then you’ll receive an offer from us. If helping unstick clinical trials and getting life-saving treatments to patients faster sounds like your idea of important work, let’s talk.

MoonLake Immunotherapeutics

JOB PURPOSE The Senior Specialist Drug Product and Device (GxP) provides comprehensive support to Technical Operations and perform essential oversight of Good Manufacturing Pratice (GMP) compliance for Drug Product (DP) and Device vendors. They will manage all Quality-related issues, oversee CAPAs, Change Controls, and handle GMP-related Temperature Excursions and Technical Complaints, collaborating effectively with the rest of the MoonLake Quality team, the Technical Operations team and consultants (where necessary). This role is responsible for the receipt, assessment, investigation, documentation, and closure of technical complaints in accordance with GxP regulations (including GMP, GCP, and GDP, as applicable). The role ensures that all technical complaints, such as device issues, temperature excursions, packaging defects, or product quality concerns, are managed in compliance with internal procedures and regulatory expectations and are appropriately recorded, investigated, trended, and reported within the electronic Quality Management System (eQMS). This role supports patient safety, product quality, and regulatory compliance across clinical and commercial activities. Key Accountabilities: * Technical Complaint Management * Act as the primary coordinator for technical complaints, ensuring complaints are logged, assessed, investigated, and closed within defined timelines using the eQMS (e.g., Qualio). * Ensure accurate completion of complaint records, including complaint details, product information, batch/lot numbers, and classification * Perform initial assessment and classification of complaints (e.g., technical vs safety‑related) and ensure appropriate escalation when required * Investigation & Root Cause Analysis * Coordinate and document complaint investigations, working with internal stakeholders and external vendors as required. * Support or lead root cause analysis, ensuring conclusions are evidence‑based and adequately justified. * Ensure CAPAs, change controls, or quality issues are raised and tracked where required following investigation outcomes. * GxP Compliance & Documentation * Ensure all complaint handling activities comply with applicable GxP regulations, internal SOPs, and Quality Management System requirements. * Maintain inspection‑ready documentation, ensuring complaint records are complete, traceable, and auditable. * Support internal and external audits and inspections by providing complaint data, metrics, and documentation as required * Work with the MoonLake Quality Team to manage and develop Quality Systems and procedures within the company * Cross‑Functional Collaboration * Liaise with Clinical Operations, Technical Operations, Quality Assurance, Pharmacovigilance, and external vendors/CDMOs to support timely resolution and Drug Product / Device assembly, labelling and packaging activities, including complaints. * Support alignment between technical complaints and related quality processes such as deviations, recalls, and serious breaches, where applicable. * Work with the Drug-Device Development Team to define and oversee activities sub contracted to vendors by MoonLake, with specific emphasis on quality and compliance requirements * Trending & Reporting * Support trend analysis of technical complaints, contributing to periodic quality reports and management review activities. * Identify recurring issues and contribute to continuous improvement initiatives within the Quality System. YOUR PROFILE Education:  * Degree in Life Sciences, Engineering, Pharmacy, or a related scientific discipline (or equivalent experience). Experience:  * Experience working in a GxP‑regulated environment (pharmaceutical, biotech, medical device, or clinical research). * Hands‑on experience with complaint handling, quality issues, or deviation management within a Quality Management System. * Familiarity with electronic QMS platforms (e.g., Qualio or similar). * Experience with device or combination product complaints (desirable). * Exposure to temperature excursions, packaging complaints, or technical product issues (desirable). * Experience supporting regulatory inspections or audits (desirable). Skills/knowledge/behavioural competencies: * Strong understanding of GxP principles and quality system processes. * Excellent documentation and technical writing skills. * Ability to manage multiple complaints simultaneously while meeting regulatory timelines. * Strong attention to detail and a structured, risk‑based approach to problem solving. * Effective communication and stakeholder‑management skills. Work Location: * 2 days a week in our brand new Porto or Cambridge office WHY US? An exciting job opportunity awaits you! MoonLake is a dynamic and innovative company pushing the boundaries of possibility, and we are looking for passionate individuals to join our stellar team. What we offer: Learning Environment: An opportunity to learn and grow alongside experienced professionals in a supportive and innovative biotech environment. Impactful Work: Contribute to ground-breaking projects that have the potential to transform global healthcare. Flexibility and Balance: Work remotely/hybrid, enjoying a healthy work-life balance while making meaningful contributions to our team. Career Growth: A clear path for career progression, with the chance to take on more responsibilities as you develop your skills. Our Core Values We look for potential MoonLakers that embody our three core values that drive our pursuit of excellence:  We do Stellar Science: We aspire to create novel therapies that elevate treatment horizons, with innovative science, and high quality, always. We go beyond: We aspire to be positively disruptive in our field, and bold in the way we challenge the norms and each other. We unlock value: We aspire to create long-term value for investors and communities.