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 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. 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 about new ideas. 
• Open: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. 
• Communicative: Proficient in written and verbal communication and collaboration skills. You are able to share ideas and support exploration of other ideas.  
• 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 tasks with input from more senior colleagues and ensure actions are completed 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!