Clinical Trial Protocol Specialist

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    "location": {
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      "postalCode": "H91 FW",
      "addressCountry": "Ireland"
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    "datePosted": "2026-05-26",
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    "description": "<p><span style=\"font-weight: bold\">Shape the Face of Cancer Treatment at Luminate Medical</span></p>\n<p>At <span style=\"font-weight: bold\">Luminate</span>, our mission is to make cancer care <span style=\"font-weight: bold\">more human</span>.</p>\n<p> </p>\n<p>Our first two products, <span style=\"font-weight: bold\">Lily</span> and <span style=\"font-weight: bold\">Lilac</span>, are revolutionary wearable devices designed to address hair loss and peripheral neuropathy respectively - two of the most common and difficult side effects of cancer treatment. We have an exciting pipeline focused on building products that help cancer patients to live, not just survive. <span style=\"font-weight: bold\">Lotus</span>, our latest solution is a next-generation system designed to make at-home cancer care more accessible and efficient for both patients and clinics.</p>\n<p> </p>\n<p>We’re looking for a <span style=\"font-weight: bold\">Clinical Trial Protocol Specialist</span> to lead the design and authorship of investigational protocols across our oncology portfolio. This is a hands-on, high-ownership role sitting at the intersection of clinical science, regulatory strategy and study operations. The role is an exciting opportunity to be part of a multi-award-winning team and play a decisive part in the development and production of life changing products. Above all, you will need to enjoy working in a fast-paced environment, be passionate about working with people, and thrive in taking responsibility for delivering projects on-time to make a real-world patient impact.</p>\n<p> </p>\n<p><span style=\"font-weight: bold\">Working at Luminate Medical</span></p>\n<ul>\n<li>This is a key early hire at a rapidly growing company. You will have an opportunity to shape the development of multiple high-impact patient-facing products and gain first-hand insights into the growth of a start-up.</li>\n<li>We offer a highly competitive salary comparable with multinational medical device companies, a flexible benefits package (including health insurance and pension), alongside a company laptop, headphones and camera.</li>\n<li>We believe in quality of life in our products and for our people, and offer flexible working hours, and a generous vacation policy.</li>\n</ul>\n<p> </p>\n<p><span style=\"font-weight: bold\">What You Will Do:</span></p>\n<ul>\n<li>Lead protocol design and authorship for Phase I-III oncology trials, including feasibility, pilot and pivotal studies. This includes, but is not limited to:\n<ul>\n<li>Generating scientific hypotheses and translating them into operationally- and submission-ready protocols,</li>\n<li>Developing study synopses,</li>\n<li>Selecting appropriate endpoints and instruments as well as patient populations, while developing appropriate scientific justifications for the preferred selections.</li>\n<li>Leading protocol amendments where required.</li>\n</ul>\n</li>\n<li>Draft and revise other study-specific documentation, such as, informed consent forms and study questionnaires.</li>\n<li>Collaborate with biostatistics partners on endpoint selection and development of statistical analyses plans.</li>\n<li>Collaborate with clinical/other partners and advisors to aid with study design, protocol narratives and scientific rationale.</li>\n<li>Ensure alignment with regulatory guidance and applicable device/drug frameworks.</li>\n<li>Engage in cross-functional review cycles.</li>\n<li>Support regulatory submissions with protocol narratives and scientific rationale documentation.</li>\n<li>Conduct targeted literature reviews to support study design and clinical assumptions.</li>\n</ul>\n<p><br><br></p>\n<p><span style=\"font-weight: bold\">Personal Attributes – The Ideal Candidate Is:</span></p>\n<ul>\n<li><span style=\"font-weight: bold\">Creative:</span>A creative problem solver who is enthusiastic about new ideas. </li>\n<li><span style=\"font-weight: bold\">Open:</span>A proactive team player who seeks to help develop your teammates. You are willing to adopt, engage with and shape company culture in a positive manner. You can give and receive candid feedback in a constructive and positive manner. </li>\n<li><span style=\"font-weight: bold\">Communicative</span>: Proficient in written and verbal communication and collaboration skills. You are able to share ideas and support exploration of other ideas.  </li>\n<li><span style=\"font-weight: bold\">Self-Driven:</span>You have a sense of urgency in your work and thrive when taking responsibility for tasks. </li>\n<li><span style=\"font-weight: bold\">Organised</span>: You can prioritise your list of tasks with input from more senior colleagues and ensure actions are completed on time.</li>\n</ul>\n<p><br><br></p>\n<p><span style=\"font-weight: bold\">Experience Requirements – The Ideal Candidate Must Have:</span></p>\n<ul>\n<li>MD/PhD/PharmD or equivalent in life sciences, medicine, or related field with demonstrated oncology background.</li>\n<li>5+ years of experience in clinical trial protocol design and authorship in general oncology.</li>\n<li>Track record of independently authored protocols for oncology trials.</li>\n<li>Proficiency with oncology-specific endpoints and CTCAE grading frameworks.</li>\n<li>Strong working knowledge of ICH guidelines and FDA regulatory expectations.</li>\n<li>Excellent written and verbal communication skills.</li>\n</ul>\n<p><br><br></p>\n<p><span style=\"font-weight: bold\">Experience Advantages – It Would Be Advantageous to Have:</span></p>\n<ul>\n<li>Experience with medical device trials (IDE SR/NSR, De Novo, 510(k)).</li>\n<li>Experience with trials on quality of life needs, including, but not limited to, quality of life as a result of physical side effects or time/financial toxicity.</li>\n<li>Familiarity with patient reported outcomes.</li>\n</ul>\n<p><br><br></p>\n<p><span style=\"font-weight: bold\">Don’t have all of these requirements?</span></p>\n<p>Some people are less likely to apply for a role unless they are 100% qualified. Your experience, skills and passion will set you apart – tell us what you have learned and achieved, whether personal or work-related! With the right mindset, many of the skills above can be learned on the job. If this role excites you, don’t let the description hold you back!</p>",
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