Health Technology Consultant
Posted 1 week ago by Pharma Design Limited
Negotiable
Inside
Remote
United Kingdom
Summary: The role of Health Technology Assessment (HTA) Consultant at Pharma Design Limited involves providing part-time support for preparing HTA dossiers for innovative gene therapy products. This remote position is suitable for experienced freelancers with expertise in advanced therapies and orphan drugs. The consultant will work flexibly, contributing to the development of economic models and ensuring compliance with regulatory guidelines. The contract is initially for 6-12 months with potential for extension.
Key Responsibilities:
- Develop and refine HTA dossiers, including cost-utility analyses (QALY-based models, NHS/PSS perspective, 3.5% discount rate).
- Align submissions with NICE HST/STA guidelines and EU Joint Clinical Assessment (JCA) requirements for ATMPs.
- Incorporate clinical data from Phase I/II/III trials into economic models and evidence submissions.
- Support joint scientific consultations (EMA/HTACG, MHRA/NICE) and pre-submission engagements.
- Conduct sensitivity analyses and ensure compliance with transparency standards (e.g., full model code access).
- Collaborate remotely with our regulatory team to integrate HTA strategies into MAA preparations.
Key Skills:
- 5+ years of HTA experience, preferably with ATMPs, gene therapies, or orphan drugs.
- Proven track record in NICE submissions (HST/STA), EU HTA (e.g., JCA), and economic modelling (Excel/Python proficiency).
- Familiarity with regulatory guidelines (EMA GVP, ATMP follow-up).
- Strong understanding of rare disease unmet needs (e.g., retinal dystrophies).
- Excellent communication skills; ability to work independently in a remote setup.
- Be an independent contractor working through your own limited company or Umbrella Agency.
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: remote
IR35 Status: inside IR35
Seniority Level: undetermined
Industry: Other
Job Opportunity Part-Time HTA Consultant for ATMP Market Access (Remote, UK/EU)
About Pharma Design Limited
Pharma Design Limited is a UK-based boutique Regulatory Affairs & Market Access consultancy specialising in supporting international biotech and pharmaceutical companies with European and UK market authorizations. We focus on advanced therapies, orphan drugs, and complex submissions, helping clients navigate EMA and MHRA processes efficiently.
Role Overview
We are seeking an experienced Health Technology Assessment (HTA) Consultant to provide part-time support (10-20 hours/week, flexible) for preparing EU and UK HTA dossiers for two innovative gene therapy products. This remote contractor position is open to candidates located anywhere in the UK or EU, with an initial 6-12 month contract and potential for extension. Ideal for freelancers with proven expertise in ATMPs and orphan indications.
Key Responsibilities
- Develop and refine HTA dossiers, including cost-utility analyses (QALY-based models, NHS/PSS perspective, 3.5% discount rate).
- Align submissions with NICE HST/STA guidelines and EU Joint Clinical Assessment (JCA) requirements for ATMPs.
- Incorporate clinical data from Phase I/II/III trials into economic models and evidence submissions.
- Support joint scientific consultations (EMA/HTACG, MHRA/NICE) and pre-submission engagements.
- Conduct sensitivity analyses and ensure compliance with transparency standards (e.g., full model code access).
- Collaborate remotely with our regulatory team to integrate HTA strategies into MAA preparations.
Requirements
- Be an independent contractor working through your own limited company or Umbrella Agency.
- 5+ years of HTA experience, preferably with ATMPs, gene therapies, or orphan drugs.
- Proven track record in NICE submissions (HST/STA), EU HTA (e.g., JCA), and economic modelling (Excel/Python proficiency).
- Familiarity with regulatory guidelines (EMA GVP, ATMP follow-up).
- Strong understanding of rare disease unmet needs (e.g., retinal dystrophies).
- Excellent communication skills; ability to work independently in a remote setup.
Location: UK or EU (for compliance/time zone alignment).
Desirable: Experience with ILAP/PRIME or joint EMA/MHRA consultations.
What We Offer
- Competitive hourly rate (based on experience).
- Flexible, part-time remote work with autonomy.
- Opportunity to contribute to ground-breaking therapies in rare diseases.
- Collaborative environment with access to our regulatory expertise.
How to Apply
Please send your CV, a cover letter highlighting relevant HTA experience, and examples of past dossiers/models to [admin@pharma-design.co.uk with the subject "HTA Consultant Application – ATMP Projects". Applications reviewed on a rolling basis; ideal start date: Immediately.