At a Glance
- Tasks: Lead NGS assay validation and guide lab accreditation processes.
- Company: Join a pioneering precision medicine company transforming cancer diagnostics with innovative liquid biopsy technologies.
- Benefits: Enjoy flexible engagement options and the chance to make a real clinical impact.
- Why this job: Shape cutting-edge molecular diagnostics while working in a dynamic, impactful environment.
- Qualifications: Must be HCPC registered with extensive NGS experience and knowledge of ISO15189 standards.
- Other info: This is a contract role based in Guildford, perfect for proactive consultants.
The predicted salary is between 43200 - 72000 £ per year.
Are you a HCPC registered Clinical Scientist with deep expertise in NGS validation and ISO15189 accreditation? This contract role offers a unique opportunity to shape the setup and compliance of a state-of-the-art molecular diagnostics lab focused on liquid biopsy.
THE COMPANY
This leading precision medicine company is redefining cancer diagnostics through liquid biopsy technologies. By capturing and analysing rare circulating tumour cells and ctDNA, their platform enables earlier, more targeted clinical interventions. With an FDA-cleared platform already in use, the organisation is now expanding into advanced molecular profiling, requiring immediate expert input on NGS validation, clinical assay deployment, and laboratory accreditation.
THE CONTRACT ROLE
As a Clinical NGS Consultant, you will play a central role in establishing and validating molecular profiling assays for clinical use. Your key focus will be the validation and regulatory readiness of NGS-based assays, ensuring alignment with ISO15189:2022 standards. You’ll advise on lab setup, lead validation efforts, and support the accreditation process.
KEY RESPONSIBILITIES
- Lead NGS assay validation for use in clinical service offerings (ctDNA, CTC DNA/RNA, methylation).
- Guide the clinical lab through ISO15189:2022 accreditation, working closely with internal teams and external bodies (e.g., UKAS, MHRA, HTA).
- Support the implementation of data analysis workflows and reporting structures for NGS within a LIMS environment.
- Provide oversight on quality, compliance, document control, and risk management related to molecular profiling.
- Advise on clinical workflow design, SOP development, and audit-readiness.
- Mentor internal staff and review technical documents and data packages for regulatory submissions.
ABOUT YOU
This contract role will suit you if you have:
- HCPC registration in a genomic discipline.
- Extensive hands-on experience with clinical NGS assay development and validation.
- Demonstrable knowledge of ISO15189 and interaction with accrediting bodies (UKAS, HTA, MHRA, CLIA).
- Competence in handling complex clinical and sequencing data, including statistical analysis.
- Strong oncology knowledge.
- A flexible, proactive approach to consultancy work and a keen eye for high-quality documentation and compliance detail.
This is a contract opportunity based in Guildford. Flexible engagement options available. To express interest or request more details, email tyler@singulartalent.io. Let’s talk about how your expertise can make a clinical impact.
Clinical Consultant employer: Singular: Building Brilliant Biotechs
Contact Detail:
Singular: Building Brilliant Biotechs Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Clinical Consultant
✨Tip Number 1
Network with professionals in the field of clinical genomics and molecular diagnostics. Attend relevant conferences or webinars where you can meet potential colleagues and learn about the latest trends in NGS validation and ISO15189 accreditation.
✨Tip Number 2
Familiarise yourself with the specific requirements of ISO15189:2022 standards. Understanding these regulations inside out will not only help you in interviews but also demonstrate your commitment to quality and compliance in laboratory settings.
✨Tip Number 3
Prepare to discuss your hands-on experience with clinical NGS assay development during interviews. Be ready to share specific examples of projects you've worked on, particularly those that involved validation and regulatory readiness.
✨Tip Number 4
Showcase your mentoring skills by preparing examples of how you've guided teams or individuals in previous roles. This will highlight your leadership capabilities and your ability to support internal staff in a consultancy capacity.
We think you need these skills to ace Clinical Consultant
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your HCPC registration, experience with NGS validation, and knowledge of ISO15189. Use specific examples from your past roles that demonstrate your expertise in clinical assay development.
Craft a Compelling Cover Letter: In your cover letter, express your passion for precision medicine and how your skills align with the company's mission. Mention your hands-on experience with NGS and your familiarity with regulatory bodies like UKAS and MHRA.
Highlight Relevant Experience: When detailing your work history, focus on roles where you led NGS assay validation or worked on laboratory accreditation. Use metrics to showcase your impact, such as successful project completions or improvements in compliance.
Proofread and Edit: Before submitting your application, thoroughly proofread your documents. Ensure there are no typos or grammatical errors, as attention to detail is crucial in this field. Consider asking a colleague to review your application for feedback.
How to prepare for a job interview at Singular: Building Brilliant Biotechs
✨Showcase Your NGS Expertise
Be prepared to discuss your hands-on experience with clinical NGS assay development and validation. Highlight specific projects you've worked on, focusing on the challenges you faced and how you overcame them.
✨Understand ISO15189 Standards
Familiarise yourself with ISO15189:2022 standards and be ready to explain how your previous work aligns with these regulations. This will demonstrate your capability to guide the lab through the accreditation process.
✨Prepare for Technical Questions
Expect technical questions related to molecular profiling assays and data analysis workflows. Brush up on your knowledge of ctDNA, CTC DNA/RNA, and methylation to confidently answer any queries.
✨Emphasise Your Mentoring Skills
Since mentoring internal staff is part of the role, be ready to share examples of how you've successfully trained or guided colleagues in the past. This will show your leadership potential and collaborative spirit.