Location
- The ideal candidate will be based in Ireland, the UK or the US East Coast.
- Frequent travel to potential partners required (10 - 20%)
- Limited international travel to Europe as required
- Regular collaboration with global teams across the U.S., Europe, and Canada
About this Role
The Head of Clinical Affairs is a new role, of critical strategic importance, with end-to-end ownership of Deciphex's clinical evidence ecosystem — spanning pre-market regulatory studies, post-market surveillance, non-clinical evidence generation, and the external partner network that sustains it across multiple regulated markets.
We are looking for an experienced clinical affairs professional who combines deep expertise in medical device software study design with the strategic instinct to build and lead a clinical evidence function, engage credibly with academic and industry partners, and navigate a complex multi-jurisdictional regulatory landscape.
This role is an excellent fit for someone who is energised by building something from the ground up, thrives at the intersection of clinical science, regulation, and commercial partnership, and wants to make a meaningful contribution to the future of digital pathology.
Responsibilities:
- Define and maintain Deciphex's clinical evidence strategy and roadmap, mapping all regulatory, commercial, and reimbursement evidence requirements to planned activities, owners, and timelines.
- Design and manage pivotal studies (e.g. 510(k) clinical concordance study), including site identification and activation, CRO selection and oversight, ethics approvals (IRB/HRA), reader panel management, statistical analysis plan, and clinical study report delivery.
- Ensure clinical concordance studies and clinical trials are fully aligned with new market entry strategy.
- Build and manage a portfolio of strategic external clinical partnerships with academic institutions, NHS trusts, CROs, and pharma/diagnostics companies that provide study infrastructure, independent validation, and co-investment in evidence generation.
- Identify and co-lead clinical trials with academic, NHS, and industry partners, including negotiating co-sponsorship structures, data ownership, and publication rights, and ensuring study outputs serve Deciphex's regulatory and commercial requirements
- Generate non-clinical evidence for regulatory submissions including systematic literature reviews, Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF) strategies, usability study coordination, and health economics and outcomes research (HEOR)
- Execute Predetermined Change Control Plan (PCCP) validation protocols; design and implement the post-market clinical surveillance plan including patient safety investigations and MDR-related events.
- Ensure clinical evidence packages satisfy FDA, EU MDR (including CER and PMCF obligations under Article 61 and Annex XIV), and UK MHRA requirements, in close coordination with the Quality and Regulatory function; support or serve as Person Responsible for Regulatory Compliance (PRRC) under EU MDR Article 15 (scope to be confirmed).
- Support FDA inspections, MDSAP audits, and notified body assessments as they relate to clinical study documentation and evidence files; coordinate site-level audit readiness across clinical partner sites.
- Work with the Director of Innovation Programs to identify and pursue grant funding opportunities (Horizon Europe, NIHR, DTIF) that co-fund the clinical evidence programme.
- Provide clinical evidence milestone, reporting to the Director of Innovation Programs, for inclusion in the innovation portfolio tracker and board reporting cadence
Required Skills and Experience:
- Degree in life sciences, medicine, pharmacy, biomedical engineering, or a related field; advanced degree preferred.
- Minimum 7 years' experience in clinical affairs or regulatory science within the medical device, SaMD or IVD industry.
- Demonstrated experience designing and managing multi-site clinical studies for Class II medical devices (ideally SaMD), with direct accountability for protocol design, site management, and clinical study report delivery.
- Proven track record developing and managing external clinical partnerships — academic, NHS, CRO, or industry — from scoping through active collaboration.
- IRB and HRA ethics approval management across multiple study sites and jurisdictions.
- Experience generating non-clinical evidence for regulatory submissions, including literature reviews, systematic evidence syntheses, or usability study oversight.
- Post-market clinical surveillance programme experience, including PMCF design for a cleared Class II medical device.
- Working knowledge of ISO 13485 and experience contributing to regulatory submission documentation within a compliant quality management system.
Desirable Skills and Experience
- Background in digital pathology, in vitro diagnostics (IVD), or imaging software medical devices is a distinct advantage.
- Experience with EU MDR Clinical Evaluation Report (CER) authorship or oversight for Class IIa/IIb devices, including PMCF planning.
- Knowledge of or experience with the Person Responsible for Regulatory Compliance (PRRC) function under EU MDR Article 15.
- Familiarity with MDSAP audit processes and multi-jurisdictional inspection readiness.
- Exposure to Predetermined Change Control Plan (PCCP) design or execution under FDORA 2022 and FDA December 2024 final guidance.
- Health economics and outcomes research (HEOR) experience, including cost-effectiveness modelling for NHS or US payer audiences.
- Experience structuring clinical evidence programmes for competitive grant funding (Horizon Europe, NIHR, DTIF or equivalent).
- Engagement with professional societies or regulatory science consortia in digital pathology, IVD, or AI-assisted diagnostics.
What are the benefits of working with Deciphex?
- Competitive salary with performance based annual increments.
- Healthcare benefits
- Competitive annual leave
- A true sense of meaning in your work by contributing to better patient outcomes.
- The opportunity to work alongside a world-class high performing team in a hyper-growth startup environment.
- A chance to work on exciting, challenging and unique projects.
- Regular performance feedback and significant career growth opportunities.
- A highly collaborative and supportive multi cultural team.
About the Company
Through the work that we do, the team at Deciphex helps pharma to accelerate the process of essential drug development and helps patients to get timely and accurate diagnosis.
Founded in Dublin in 2017, Deciphex has scaled rapidly to a team of over 230 people and counting who are providing software solutions to address the pathology gap in research pathology and clinical areas. We have offices in Dublin, Exeter, Oxford, Toronto and Chicago and are expanding our team throughout the world.
We are software developers, clinical specialists, AI engineers, operations professionals and so much more, all working as one team to support our customers and patients. Our team culture is built on trust. We give our team the space they need to deliver results and the environment to ensure they can enjoy doing it.
We are looking for highly motivated individuals who are excited to take on challenges and value making a difference in their day-to-day work. This is a unique opportunity to make a difference in the emerging Digital Pathology field.
Read more about Deciphex here and more about our incredible team on our Careers Page here
Deciphex is an equal opportunities employer and we are committed to the principle of equality. All qualified applicants will be considered for employment without regard to age, race, religious beliefs, political views, gender identity, affectional or sexual orientation, national origin, family or marital status (including pregnancy), disability, membership of the travelling community or any other classification protected by applicable law.
A copy of our Privacy Policy can be viewed here
