Clinical Trial Protocol Specialist

Shape the Face of Cancer Treatment at Luminate Medical

At Luminate , our mission is to make cancer care more human .

Our first two products, Lily and Lilac , are revolutionary wearable devicesdesigned toaddresshair loss andperipheral neuropathy respectively - two of the most common anddifficult side effects of cancer treatment. We have an exciting pipeline focused on building products that help cancer patients to live, not just survive. Lotus , our latest solution is a next-generation system designed to make at-home cancer care more accessible and efficient for both patients and clinics.

We're looking for a Clinical Trial Protocol Specialist 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.

Working at Luminate Medical

• 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.
• 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.
• We believe in quality of life in our products and for our people, and offer flexible working hours, and a generous vacation policy.

What You Will Do:

• Lead protocol design and authorship for Phase I-III oncology trials, including feasibility, pilot and pivotal studies. This includes, but is not limited to:
  • Generating scientific hypotheses and translating them into operationally- and submission-ready protocols,
  • Developing study synopses,
  • Selecting appropriate endpoints and instruments as well as patient populations, while developing appropriate scientific justifications for the preferred selections.
  • Leading protocol amendments where required.
• Draft and revise other study-specific documentation, such as, informed consent forms and study questionnaires.
• Collaborate with biostatistics partners on endpoint selection and development of statistical analyses plans.
• Collaborate with clinical/other partners and advisors to aid with study design, protocol narratives and scientific rationale.
• Ensure alignment with regulatory guidance and applicable device/drug frameworks.
• Engage in cross-functional review cycles.
• Support regulatory submissions with protocol narratives and scientific rationale documentation.
• Conduct targeted literature reviews to support study design and clinical assumptions.

Personal Attributes - The Ideal Candidate Is:

• Creative: A creative problem solver who is enthusiastic aboutnew ideas.
• Open: A proactive team player whoseeksto 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.
• Communicative :Proficientin written and verbal communication and collaboration skills. Youare able toshareideas and supportexploration of otherideas.
• Self-Driven: You have a sense of urgency in your work and thrive when taking responsibility for tasks.
• Organised :You can prioritise your list of taskswith input from more senior colleaguesand ensureactions arecompleted on time.

Experience Requirements - The Ideal Candidate Must Have:

• MD/PhD/PharmD or equivalent in life sciences, medicine, or related field with demonstrated oncology background.
• 5+ years of experience in clinical trial protocol design and authorship in general oncology.
• Track record of independently authored protocols for oncology trials.
• Proficiency with oncology-specific endpoints and CTCAE grading frameworks.
• Strong working knowledge of ICH guidelines and FDA regulatory expectations.
• Excellent written and verbal communication skills.

Experience Advantages - It Would Be Advantageous to Have:

• Experience with medical device trials (IDE SR/NSR, De Novo, 510(k .
• 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.
• Familiarity with patient reported outcomes.

Don't have all of these requirements?

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!