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.
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.
