Clinical Operations Specialist

Who is BioOra?
BioOra is proud to be New Zealand's first Chimeric Antigen Receptor CAR T-cell manufacturing company. At the forefront of cell therapy innovation, we are currently manufacturing for a Phase II clinical trial and advancing toward large scale commercial production. Our goal is to revolutionise cancer immunotherapy by automating and scaling the production of CAR T-cells, to deliver this potentially life-saving technology to those who need it.  
 
What will you do?
Take the lead in optimising an ongoing  clinical trial and build the foundations for future clinical operations and delivery of CAR-T cell therapy. Working closely with internal teams, trial sponsors and external CROs, you will design and embed fit-for-purpose tools, processes, and systems that improve trial execution, manage the transition of trial data at close-out and set BioOra up for the future. This role has a New Zealand base with some travel to trial sites and occasional international travel as our clinical footprint grows.
In this role you will:

• Optimise clinical operations for an ongoing trial, working alongside the trial sponsor and CRO to strengthen delivery.
• Lead trial close-out and post-trial data migration, working with the sponsor and CRO to transfer clinical data and records into fit-for-purpose systems that support long-term follow-up.
• Work closely with CROs and clinical trial sites across NZ to improve day‑to‑day trial delivery.
• Design, implement, and maintain core clinical operations tools and systems for key clinical operations activities.
• Collaborate with cross-functional teams to streamline interfaces between manufacturing, medical affairs and clinical operations.
• Build scalable processes for future trials and support the future growth of BioOra's advanced cell therapies.

What do you bring to the role?
Bring your proven experience in clinical operations to a dynamic organisation with room to grow. You will have a proactive approach, and will thrive in an ambiguous, fast-moving environment where you can build structure and tools from the ground up. Your ability to influence, build relationships and ability to balance quick wins with future scalable solutions will be critical in this role. We need someone who is collaborative, resilient, and motivated by improving patient outcomes through high-quality clinical trials.
Technical skills

• A relevant tertiary qualification in life sciences or a related discipline
• A solid background in clinical research operations with hands on experience coordinating or overseeing trials run in partnership with CROs
• Proven experience working on interventional clinical trials, ideally including complex/advanced therapies.
• Strong operational capability with experience using and building clinical systems and processes
• Experience with trial close-out and clinical data management and an understanding of long-term follow-up requirements for cell and gene therapies.
• Proven ability to work cross functionally with production, QA/RA, and clinical teams to solve operational problems and improve ways of working.
• High attention to detail, excellent organisational skills, and a track record of delivering results in environments where not everything is fully defined.

Why join us?
We are a values-based organisation, because we're creating something EPIC! Here's how...

• Excellence - We strive for the highest standards in everything we do
• Passion - We bring enthusiasm and dedication to our work
• Innovation - We embrace creativity and push boundaries
• Collaboration - We thrive together valuing every voice
• ! - We go the extra mile to make a difference!

This role is ideally based in Wellington, however for an exceptional candidate we will consider Christchurch or Auckland.
 
When you apply
Every application is screened by a human who wants you to live up to your EPIC! application! 

• So if your purpose lies in making a meaningful difference in the fight against cancer, tell us why with an up-to-date CV and short introduction letter.
• As much as we know AI has its place, we're not fans when it comes to cover letters. We therefore ask for **no AI cover letters,**and with the number of applications we get it's very easy to tell if you do!
• Please, if you see more than one role advertised only apply onceour humans will assess fit across the organisation.

We'll also be checking you've answered the following question: What topic could you give a 5+ minute presentation on without any preparation?
 
Applications close Wednesday 21st October 2026.
 
We will be reviewing applications as they come in. We encourage early applications as the advert may close early.
*Please note, to be considered for this role you MUST already have the legal right to work in New Zealand.