Chief Technology Officer
Black Swans Exist
agency
Denmark (Hybrid)
Part Time
About the Role
CTO (Part-Time) | Women’s Health Diagnostics | University spin-out
Black Swans Exist is exclusively asked to identify a visionary, hands-on Chief Technology Officer (CTO) for a pioneering women’s health diagnostics company – a biotech spin-out from a leading university institute.
This is a pivotal leadership role: you will architect the transition of a scientifically robust academic assay into a market-ready, scalable In-Vitro Diagnostic (IVD) product, shaping the full product development and commercialization strategy.
The mission
Endometriosis impacts millions of women globally, yet diagnosis often requires invasive surgery and can take ~7 years on average. This venture is developing a novel, non-invasive diagnostic test designed to fundamentally change that journey.
Backed by a large clinical cohort, strong data, and leading life science investors (including BioInnovation Institute (BII)), the company is entering a phase where technology, product strategy, and regulatory execution will determine speed-to-market.
Endometriosis impacts millions of women globally, yet diagnosis often requires invasive surgery and can take ~7 years on average. This venture is developing a novel, non-invasive diagnostic test designed to fundamentally change that journey.
Backed by a large clinical cohort, strong data, and leading life science investors (including BioInnovation Institute (BII)), the company is entering a phase where technology, product strategy, and regulatory execution will determine speed-to-market.
What you will ow
Product Development Strategy
- Define and execute the product roadmap to move from a mass spectrometry-based approach to a scalable, accessible IVD format
- Establish technical specs, milestones, and MVP strategy for early market entry and revenue
Platform & Technology Evaluation
- Lead diligence across potential diagnostic platforms (e.g., immunoassays, molecular diagnostics)
- Drive assay transfer, optimization, and validation on the selected platform
Clinical & Regulatory Leadership
- Provide strategic oversight of clinical validation studies (design, endpoints, sample strategy)
- Build a multi-market regulatory plan (EU, US, Asia), incl. reimbursement considerations
- Identify early access opportunities (e.g., LDT pathways / regulatory designations)
Strategic Partnering & Fundraising Support
- Partner closely with CEO and academic founders to craft an investable development narrative for Seed / Series A
- Act as the primary technical voice with investors, partners, and KOLs
What we’re looking for
- Proven track record leading diagnostic product development from research/discovery through commercial launch
- Deep experience in IVD (essential)
- Strong capability in preclinical/clinical planning and execution for diagnostic products
- Demonstrated experience transitioning assays between platforms
- Solid understanding of global regulatory pathways (FDA, CE-IVDR, and other international frameworks)
- Startup/early-stage mindset: strategic, resourceful, pragmatic
- Strong communication skills—able to bridge academic science and commercial product reality
- Women’s health interest/background is a plus
Why this role stands out
- Transform women’s health by enabling faster, non-invasive diagnosis
- Define the company’s destiny: product, regulatory, and commercialization strategy sit with you
- Build on a validated foundation: the science works—your challenge is delivering it to the world at scale
Process / How to apply
This search is managed by Black Swans Exist.
To apply or discuss the opportunity confidentially, please share your CV and a short note outlining relevant IVD leadership and platform transition experience with our team.
This search is managed by Black Swans Exist.
To apply or discuss the opportunity confidentially, please share your CV and a short note outlining relevant IVD leadership and platform transition experience with our team.
Please let Black Swans Exist know that you found this role at ctojobshq.com as a way to support us, so we can keep providing you with great CTO job opportunities.