Clinical Associate
Hardian is at the forefront of digital health, helping global companies get their healthtech to market. We work with startups to large corporations on anything from mobile health apps to diagnostic AI solutions. We are experts in SaMD, AIaMD and software-driven IVDs, with a finger on the pulse of the shifting regulatory landscape. We believe healthtech is the future.
Hardian is expanding and is seeking a proactive and fast-learning clinical associate to join our in-house clinical team. The ideal candidate will have a desire to learn and grow in their role, while helping build a fast-growing niche consultancy in the health technology sector. This early career role requires a passion for clinical evidence, quality assurance, cutting-edge medical software and attention to detail.
Overview of company and job details:
Hardian is a fast paced, clinically-led expert consultancy at the cutting edge of medical technology, specialising in SaMD.
This is a full time junior/mid position, reporting to and learning from more senior consultants.
We are a virtual company with quarterly in person meet ups. This role can be performed fully remote (location of your choice, including international nomad).
Flexible work hours (40 per week), work when you want, fit work around your life.
You must be registered to work in the UK. Hardian does not provide sponsorships.
Remuneration: £45K PA salary.
Company MacBook Air or Pro, depending on your specific needs.
Benefits include pension scheme, home office set up, comprehensive private health insurance, company benefits scheme, 28 days annual leave per year, including guaranteed Christmas break.
Discretionary end of year performance-based bonus scheme.
Personal budget for relevant professional development activities/courses, and home-office setup.
Details of the role:
As a Clinical Associate (a junior/mid-level role), you will play a key part in guiding the product strategy, clinical evaluations, and regulatory submissions for our clients developing Software and AI medical devices. You will have the ability to work independently, and be responsible for managing day-to-day client relationships, liaising with other members of the Hardian Clinical and Regulatory teams. There is also the opportunity for joining collaborative projects with our Health Economics, IP, and Market Strategy teams.
The Clinical team at Hardian prides itself in being dynamic, self-driven and multidisciplinary. Outside of the fixed key responsibilities outlined below, with time you will have the opportunity to carve out your own niche, depending on your skills and interests e.g. getting more involved in Health Economics, Cybersecurity, Risk Management, Software Design/Requirements etc.
Key Responsibilities:
Product and Regulatory: Support our clients in developing their product and regulatory strategy internationally.
Scientific Research: Conduct comprehensive systematic literature searches (both academic i.e. PRISMA style, and commercial) for regulatory submissions.
Clinical Evaluation: Independently design clinical investigation protocols, including determining appropriate endpoints, sample size calculations, and data requirements.
Medical Writing: Write clear and concise scientific documentation for medical device files.
Other Responsibilities:
Opportunities to collaborate with the Health Economics and Market Strategy teams, and be involved in Due Diligence projects.
Writing insight articles on the cutting edge of clinical AI.
Opportunities to attend relevant AI/Health Tech conferences and represent Hardian.
Following sufficient experience, opportunities to deliver educational workshops and seminars on clinical aspects of AI and Software as a Medical Device.
Business development activities.
Qualifications, skills and experience:
Required:
Medical degree (MBBS or equivalent) or PhD in biological/medical/life sciences or biomedical engineering.
Strong demonstrable skills in statistics and primary research, including study design, sample sizing, and statistical analysis (e.g. through PhD thesis or peer-reviewed publications).
Ability to conduct systematic literature reviews and critically appraise scientific research.
Self-driven and takes initiative: Working in a remote and flexible company, you must be proactive in managing your time and work, take the initiative to move projects forward without micro-management, and develop your own specific interests.
Excellent communication and teamwork skills: This is a client-facing role from day 1. You will be responsible for engaging in day-to-day client relations, and work closely with other Hardian team members.
Problem solving: You must have strong analytical and problem-solving skills with the ability to independently troubleshoot product and scientific issues, and develop feasible solutions under tight deadlines.
Preferred:
Experience working in the medical devices industry (especially in software or AI), under EU MDR, UK MDR or FDA requirements, designing Clinical Investigations to ISO 14155.
Experience writing code for Data Science or AI/ machine learning tools.
If from a medical background, completion of foundation training.
NIHR Good Clinical Practice certified.
Who you’ll be working with
Our clients range from small startups to large corporations, based around the world, all working on cutting edge health technologies including mobile health apps, diagnostic and therapeutic software, and AI/ML solutions.
Hardian is committed to welcoming, celebrating and thriving on diversity.
You’ll be working within our multi-disciplinary team, combining regulatory and clinical expertise, and directly reporting to:
Dr Ankeet Tanna, Senior Consultant - Clinical
Dr Felicity Lock, Consultant - Clinical
Application process:
CV and cover letter screening
30 minute screening call with Operations/HR Manager
90 minute competence-based interview with Clinical Team Lead
30 minute call with Hardian Health Managing Director
Please note that all applicants must have the legal right to work in the UK, as we are unable to provide visa sponsorship for this role. Candidates without the necessary work authorisation will not be considered.
