Lindus

• Set and own the regulatory strategy across the portfolio: pathway selection, endpoint and pivotal design implications, designations (breakthrough, orphan, fast track), and the regulatory shape of each program's value-inflection point. • Lead FDA interactions directly (Pre-IND, IND approval, End-of-Phase 2, Type B/C), as the Lindus person in the room, and support the CDO and executive team on the highest-stakes regulatory decisions. • Bring in and manage external regulatory experts and KOLs for specialist or region-specific questions, and work with CMC and clinical colleagues to keep filings and agency submissions coherent across functions. • Assess regulatory risk and pathway credibility during asset diligence, pressure-test clinical development plans against likely agency positions, and build the regulatory intelligence that informs exit conversations.

• Own CMC oversight across every active asset: drug substance and drug product, analytics, stability, comparability, supply, quality, GMP ownership, QP release, and the CMC sections of regulatory filings. Keep every program on time and on budget, and feed CMC realities into clinical development planning. • Select, contract, and manage CDMOs, testing labs, and other suppliers, holding them to timelines, quality, and cost. This is a core part of the role, not a secondary responsibility. • Scope and de-risk the CMC of inherited and in-licensing candidate assets, flagging manufacturing complexity or cost that could make an otherwise attractive asset uneconomic, and identifying where formulation choices create protectable IP value. • Build and manage a network of CMC KOLs and consultants, and support regulatory and clinical colleagues on CMC content for FDA and other agency interactions.

Role Description We're seeking an experienced Biostatistician to serve as an independent member of the Data and Safety Monitoring Board (DSMB) for an upcoming FDA-regulated clinical study. The study evaluates a mobile health (mHealth) application designed for menstrual period monitoring and contraceptive guidance. As the independent statistical expert on the board, you'll play a critical role in ensuring participant safety and study integrity. You'll: - Review interim analysis reports - Provide evidence-based recommendations on study continuation, modification, or termination against predefined FDA stopping criteria - Work alongside fellow board members including clinicians and epidemiologists This is a sporadic, as-needed engagement over an anticipated 18-month study duration, with approximately three DSMB meetings plus an initial organisational meeting. Each meeting cycle requires roughly 6–8 hours of effort including pre-meeting report review and meeting attendance. Qualifications - Ph.D. or Master's degree in Biostatistics, Statistics, or a closely related field - Prior experience serving on a DSMB or Data Monitoring Committee (DMC), ideally for FDA-regulated studies under IDE/PMA or IND pathways - Strong working knowledge of sequential interim analyses, group sequential designs, and stopping rule boundaries - Familiarity with Software as a Medical Device (SaMD), mobile health applications, or contraceptive and reproductive health studies (highly desirable, though not essential) - Free of significant conflicts of interest (financial, professional, or personal) with the study sponsor or the product under evaluation - Reliable and discreet, understanding the importance of maintaining strict confidentiality around unblinded interim data and closed board discussions - Embodies Lindus Health values: Be Transparent, High Agency, and Benefit Patients Requirements - Evaluate periodic interim analysis reports covering safety, efficacy, and data quality - Assess study progress against FDA-recommended stopping boundaries and safety thresholds - Participate in closed DSMB sessions to discuss findings with fellow board members - Contribute to the formulation of official DSMB recommendations to the sponsor - Maintain strict confidentiality regarding all unblinded interim data, deliberations, and board recommendations Benefits - Competitive 1099 rate tied to the engagement - Flexible, ad-hoc engagement model designed to fit around your clinical practice - Direct exposure to a high-quality portfolio of clinical trials and innovative sponsors - The chance to shape how respiratory research is run - A collaborative, mission-driven culture where your clinical expertise is genuinely valued Company Description We're powering biology's century with radically faster, more reliable clinical trials. Since March 2021, we've powered 100+ clinical trials involving tens of thousands of patients. We recently raised a $55M Series B from Balderton Capital, alongside backing from Creandum, Firstminute, Seedcamp, and Visionaries. When you join us, you’ll experience: - High-Impact, Mission-Driven Work - Fast-Paced Growth & Ownership - Collaborative, No-Ego Culture

• Owning clinical development strategy across the LTx portfolio, determining how each asset reaches a value-generating Phase 2 proof-of-concept readout quickly and capital-efficiently. • Take a voting position on Lindus’ investment committee (alongside CEO and CMO), selecting which assets to in-license and develop • Designing Phase 1 and Phase 2 studies, including FIH and dose-escalation strategy, endpoints, patient population, biomarker approach and go/no-go criteria. • Leading scientific and clinical diligence on shortlisted assets alongside the deal team and external experts, and making the developability call. • Building and directing a virtual development organization: recruiting and managing fractional and consultant CMC, regulatory, pharmacology and clinical talent. • Designing each program backward from the exit, ensuring the Phase 2 clinical and CMC package is built for what a strategic or specialty pharma buyer will pay for. • Partnering with the VP Corporate Development on asset evaluation, deal structuring and negotiation, providing the development view into diligence. • Leading regulatory interactions with the FDA, EMA and other agencies, including pre-IND meetings, Type B interactions and scientific advice procedures. • Representing LTx's development thesis with investors, partners and the board.

Role Description We're looking for a freelance CRA to ensure effective, risk-proportionate monitoring of Lindus Health's global portfolio of clinical trials, with immediate focus on supporting a major trial across 15+ US sites involving over 7,000 patients. Primary emphasis on remote monitoring, though some onsite visits may be required. - Undertake the preparation, conduct and reporting for all types of monitoring visits, from site selection through to close-out visits. - Conduct central monitoring through our Citrus platform. - Maintain high monitoring standards as our customer base grows significantly. - Work autonomously within a lean team structure, directly interfacing with Trial Managers to help shape monitoring strategy. - Collaborate closely with Clinical Operations, Product and Commercial teams, as well as sponsor-side teams. Qualifications - 3+ years of independent site monitoring experience across all types of monitoring visits (Site selection, SIV, IMV through close-out). - Experience with Decentralized Clinical Trials (DCT) and central monitoring approaches. - Strong working knowledge of GCP/GDP and regulatory requirements. - Great attention to detail and confident communication with internal and external stakeholders. - Experience in a startup or early-stage environment is advantageous. - Excitement about shaping clinical trial technology and working in a collaborative environment. Requirements - Develop strategies to effectively support remote monitoring. - Review and develop monitoring plans effectively. - Understand how to take a risk-proportionate approach to monitoring. - Strong awareness of clinical trial regulations and potential changes to the regulatory environment. - Autonomous, proactive, organized, and creative with a bias to action. Benefits - Work on high-impact clinical trials. - Collaborate with industry-leading teams. - Enjoy flexible scheduling and project variety. - Competitive contractor rates. - Leverage established infrastructure and resources. - Work with a stable, well-funded organization. - Contribute expertise to meaningful research. - Receive comprehensive support from our ClinOps team. - Flexibility of working as a contractor. Company Description We're powering biology's century with radically faster, more reliable clinical trials. Our mission is to fundamentally change the clinical trial infrastructure, ensuring new treatments reach patients faster. - Since March 2021, we've powered 100+ clinical trials involving tens of thousands of patients. - Recently raised a $55M Series B from Balderton Capital, alongside backing from Creandum, Firstminute, Seedcamp, and Visionaries.

Role Description We're looking for a Participant Recruitment Coordinator to join our Clinical Operations team on a freelance basis to support the growth of our team and manage participant interactions across our trials. This role requires you to be a Registered Nurse (RN) with active NMC registration. Qualifications - You are a Registered Nurse with current, active NMC registration (this is essential for the role). - You have experience utilising various tech tools; bonus points if these include Calendly, DocuSign, Medi2data, Dialpad, Florence and Sealed Envelope. - You have experience in patient onboarding and set-up, including running screening calls and patient follow-up. - You have experience maintaining a tracking system and executing follow-up procedures. - You have high agency and a bias for action, can adhere to protocol timelines and stay flexible in response to shifting work priorities and issues. - You're passionate and curious about our mission: changing how the healthcare industry operates and how new health treatments are developed. - You want to learn what life is like at a high-growth, mission-driven VC-funded startup. Requirements - Conduct all participant-facing tasks, ensuring a positive trial experience and excellent data accuracy within our platform, Citrus. - Apply your clinical expertise as a Registered Nurse to support participant safety, clinical judgement and trial conduct. - Oversee data collection and in-person processes (e.g. MRI scans), ensuring everything runs smoothly. - Maintain and update participant trackers and the Investigator Site File (ISF). - Assist the PI with day-to-day trial implementation and respond to CRO queries. - Respond to any CRO data queries. - Escalate safety, data integrity or trial operational issues to the TL/CRO team. - Report AEs and SAEs in line with protocol and regulatory requirements. - Collaborate effectively with trial teams to ensure seamless participant experiences throughout the trial journey. - Contribute to team discussions by sharing participant feedback and suggesting process improvements. - Work cross-functionally with Clin Ops, keeping the TL and STM updated at all times and ensuring other PRCs are aware of trial status. Benefits - High-Impact, Mission-Driven Work: Lindus is disrupting an outdated industry, giving you the chance to directly improve patients’ lives and see tangible results from your work. - Fast-Paced Growth & Ownership: We recognise hard work and outcomes over anything else. You’ll take on real responsibility, work across different areas, and actively shape the company’s success. - Collaborative, No-Ego Culture: Work with smart, driven people in a supportive and informal environment. At Lindus we break down silos, fun is a core value, and creativity is encouraged. Company Description We're powering biology's century with radically faster, more reliable clinical trials. Every new treatment needs clinical trials to prove safety and efficacy, but today's infrastructure is stuck in the past- driving up cost, causing delays and ultimately meaning new treatments don’t get to patients. We're fundamentally changing that- not just being a "better CRO," but transforming how people think about developing new treatments, so patients can access breakthrough treatments faster. Our impact speaks for itself: - Since March 2021, we've powered 100+ clinical trials involving tens of thousands of patients. - We recently raised a $55M Series B from Balderton Capital, alongside backing from Creandum, Firstminute, Seedcamp, and Visionaries.

Role Description We're looking for a Program Operations Manager to join our team in the US. This is a broad, high-impact role sitting at the intersection of project management, data, and operational improvement - working across our portfolio of clinical trials to make them run better. This role would suit someone who combines project management instincts with a strong data literacy - someone who wants to solve problems. It will suit someone with strong proactivity, organization, project management and communication skills. You'll report into the VP of Programme Operations and work day-to-day with our ClinOps, Product, and Data teams. What you’ll focus on - Lead high-priority operational improvement and transformation projects across the trial portfolio - Identify performance bottlenecks on our trials, inefficiencies, and delivery risks, and develop practical solutions - Analyse operational and trial performance data to generate insights, support forecasting, and inform decision-making - Partner cross-functionally with teams including Clinical Operations, Recruitment, and other operational stakeholders to improve delivery against timelines and budgets - Support trial teams on specific project-based challenges, including diagnosing root causes of underperformance and recommending corrective actions - Build clear, data-driven views of trial performance, including progress against recruitment, timelines, resourcing, and cost assumptions - Improve operational processes, tools, and ways of working to increase efficiency and execution quality across the portfolio - Communicate recommendations clearly to stakeholders and drive alignment on priorities, trade-offs, and next steps - Flex across different business-critical initiatives as company priorities evolve Qualifications - 3+ years of experience in an operational or project management (or similar) in a fast-growing start-up or scale-up - alternatively this role might suit someone from a top-tier consulting firm - Strong problem-solving skills - able to break down ambiguous problems, identify root causes, and turn analysis into practical action - Highly comfortable with data, spreadsheets, and structured analysis; confident working with trackers, models, and operational performance data - Highly organised with strong attention to detail - you're the person who spots when something's fallen through the cracks - A clear communicator, comfortable working across teams and at different levels of seniority - Proactive and self-directed - you don't wait to be told what to do next - Curious about clinical trials and what it takes to run them well at scale - Comfortable working in a fast-moving environment where priorities shift and no two weeks look the same Benefits - Competitive salary plus meaningful equity - you'll own a piece of what we're building - $2,000 annual Learning & Development budget for courses, certifications, and conferences - 39 days annual leave (27 days PTO + 11 federal holidays + 1 James Lind Day) - $800 monthly employer contribution for insurance coverage (via Trinet PEO) - $40 monthly wellness allowance with flexibility on how to spend this, including opting in to a company private health insurance or wellhub membership - Access to gym and retail discounts through Happl - Monthly lunch vouchers for remote team members - Regular company events and team gatherings (both virtual and in-person) - Charity partnerships and volunteering opportunities with Forward Trust - Work with a team that's genuinely changing healthcare for the better Our hiring process We believe hiring should be transparent, respectful of your time, and give you a real feel for what Lindus is like. Here's what to expect: - Online Logical Reasoning and Problem Solving test (15 minutes) - Initial conversation with Heather, our ClinOps Talent Partner (20 minutes) - Second meeting with our VP of Program Operations (30 minutes) - Technical/functional interview with two members of our Program Operations team (45 minutes) - Values interview with two team members of leadership (30 minutes) We will only contact you from lindushealth.com email addresses. Please check the spelling of emails which appear to come from Lindus carefully before responding. We will never ask for your financial information over email. We are an equal opportunity employer committed to building a diverse and inclusive workforce. We evaluate all candidates based solely on their skills, experience, and qualifications relevant to the role. We do not discriminate on the basis of race, ethnicity, religion, gender, gender identity, sexual orientation, age, disability, veteran status, or any other legally protected status.

Role Description We’re looking for an (Associate) Director of Data Management to lead the quality, compliance, and modernisation of data management practice across Lindus' clinical trial portfolio. Reporting to the VP of Data, you’ll bridge deep clinical data expertise with a forward-looking approach to technology, embedding AI-assisted ways of working and building the technical capabilities of an experienced team. - Own data quality across the full trial lifecycle, from the integrity of data collection through to the handover of clean, analysis-ready datasets. - Carry direct management responsibility for a geographically distributed team of senior and mid-level data managers across the UK and US, developing them through deliberate coaching and structured development. - Set the standard for what excellence looks like in clinical data management at Lindus. - Partner closely with Biostatistics, Deployment, Clinical Operations, Product, and Quality. - Play a central role in shaping Citrus, our end-to-end clinical trial delivery platform. Qualifications - 8+ years of experience in clinical data management or a closely related field within pharma, biotech, or a CRO environment. - Demonstrated track record of developing and mentoring others, whether through formal line management or senior, hands-on technical leadership. - Experience introducing new technology or ways of working within a clinical data team. - Strong working knowledge of relational databases and report building, applied in a clinical data management context. - Deep applied knowledge of data standards (e.g. CDASH, SDTM) and confident application in a modern data environment. - Experience supporting regulatory inspections or audits, with understanding of good documentation and inspection-readiness. - Preferred experience introducing or overseeing AI or ML tools in a regulated clinical setting. - Prior experience in a high-growth or startup environment is advantageous. - Comfort operating with ambiguity and shifting priorities is essential. - Embodiment of Lindus Health values: Be Transparent, High Agency, and Benefit Patients. Requirements - Lead and develop a geographically distributed team of senior and mid-level data managers. - Define what excellence looks like in data management practice. - Establish and advance SOPs, training programmes, and ways of working. - Manage data quality standards across the full trial lifecycle. - Oversee data management activities across all trials. - Ensure data management processes and outputs meet CDISC standards. - Act as the escalation point for complex data quality issues and sponsor queries. - Represent the data management function in quality audits and inspections. - Embed AI-assisted approaches to data quality within day-to-day workflows. - Identify opportunities to automate repetitive data management workflows. - Implement modern data tooling across the team. - Partner with Deployment, Biostatistics, Clinical Operations, Product, and Quality teams. Benefits - Competitive salary plus meaningful equity. - £1,000 annual Learning & Development budget for courses, certifications, and conferences. - 39 days annual leave (30 days PTO + 8 bank holidays + 1 James Lind Day). - £60 monthly wellness allowance with flexibility on spending. - Access to gym and retail discounts through Happl. - Monthly lunch vouchers for remote team members. - Regular company events and team gatherings (both virtual and in-person). - Charity partnerships and volunteering opportunities with Forward Trust. - Work with a team that's genuinely changing healthcare for the better. Company Description We are an equal opportunity employer committed to building a diverse and inclusive workforce. We evaluate all candidates based solely on their skills, experience, and qualifications relevant to the role. We do not discriminate on the basis of race, ethnicity, religion, gender, gender identity, sexual orientation, age, disability, veteran status, or any other legally protected status.

Role Description We're looking for a full-time CRA to ensure effective, risk-proportionate monitoring of Lindus' global portfolio of clinical trials, with immediate focus on supporting a major trial across 15+ US sites involving over 7,000 patients. Primary emphasis on remote monitoring, though some onsite visits may be required. - Undertake the preparation, conduct, and reporting for all types of monitoring visits, from site selection through to close-out visits. - Conduct central monitoring through our Citrus platform. - Maintain high monitoring standards as our customer base grows significantly. - Work autonomously within a lean team structure, directly interfacing with Trial Managers to help shape monitoring strategy. - Collaborate closely with Clinical Operations, Product, and Commercial teams, as well as sponsor-side teams that make up our customer base. Qualifications - 3+ years of independent site monitoring experience across all types of monitoring visits (Site selection, SIV, IMV, COV). - Experience with Decentralized Clinical Trials (DCT) and central monitoring approaches. - Strong working knowledge of GCP/GDP and regulatory requirements. - Great attention to detail and confident communication with internal and external stakeholders. - Autonomous, proactive, organized, and creative with a bias to action. - Comfortable with up to 60% travel during busy periods. - Ideally based in the East Coast Time Zone near a major airport hub. - Full US driving license. - Experience in a startup or early-stage environment is advantageous. Requirements - Develop strategies to effectively support remote monitoring. - Review and develop monitoring plans effectively. - Understand how to take a risk-proportionate approach to monitoring. - Strong awareness of clinical trial regulations and potential changes to the regulatory environment. Benefits - Competitive salary plus meaningful equity. - $2,000 annual Learning & Development budget for courses, certifications, and conferences. - 39 days annual leave (27 days PTO + 11 federal holidays + 1 James Lind Day). - $800 monthly employer contribution for insurance coverage (via Trinet PEO). - $40 monthly wellness allowance with flexibility on spending. - Access to gym and retail discounts through Happl. - Monthly lunch vouchers for remote team members. - Regular company events and team gatherings (both virtual and in-person). - Charity partnerships and volunteering opportunities with Forward Trust. Company Description We're powering biology's century with radically faster, more reliable clinical trials. Our impact speaks for itself: Since March 2021, we've powered 100+ clinical trials involving tens of thousands of patients. We recently raised a $55M Series B from Balderton Capital, alongside backing from Creandum, Firstminute, Seedcamp, and Visionaries.

Role Description We’re building out our network of Clinical Subject Matter Experts and are looking for a board-certified respiratory physician (pulmonologist) to partner with us on a 1099 contract basis. You’ll act as a trusted clinical advisor across the lifecycle of our respiratory trials - from protocol design and feasibility through to study delivery, safety oversight, and sponsor engagement. This is an ad-hoc, as-needed engagement. You’ll be called in when our teams need a board-certified pulmonologist’s perspective: - Helping us design protocols that work in real-world respiratory practice - Sense-checking inclusion/exclusion criteria - Advising on patient safety - Lending scientific credibility to conversations with sponsors and investigators You’ll partner closely with our Clinical Operations, Medical, and Business Development teams, while retaining the flexibility of a contractor model. This is a fully remote engagement open to respiratory physicians licensed and practising in the United States. Qualifications - Board-certified pulmonologist / respiratory physician with an active US medical licence - Track record of clinical practice in pulmonary and/or critical care medicine - Meaningful exposure to clinical research - Ability to translate clinical reality into research design - Comfort advising across respiratory indications - Strong communication skills - Responsive and reliable - Comfortable working independently as a 1099 contractor - Excited to share expertise across multiple studies - Embodies Lindus Health values: Be Transparent, High Agency, and Benefit Patients Requirements - Provide expert review of respiratory trial protocols - Sense-check recruitment assumptions - Identify practical barriers to enrolment - Lend clinical and scientific credibility to prospect conversations - Offer ad-hoc clinical guidance on safety signals and adverse events - Act as a peer voice to investigators and external KOLs - Share insights from clinical practice and the wider pulmonology community Benefits - Competitive 1099 rate tied to the engagement - Flexible, ad-hoc engagement model - Direct exposure to a high-quality portfolio of clinical trials - Chance to shape how respiratory research is run - Collaborative, mission-driven culture Company Description We are an equal opportunity employer committed to building a diverse and inclusive workforce. We evaluate all candidates based solely on their skills, experience, and qualifications relevant to the role. We do not discriminate on the basis of race, ethnicity, religion, gender, gender identity, sexual orientation, age, disability, veteran status, or any other legally protected status.