Drive the future of clinical diagnostics through innovative assay development and scientific leadership.
Proclinical is seeking a Director of R&D to lead the development of clinical assays and companion diagnostics (CDx) within the immuno-oncology and pharmaceutical space. This role focuses on advancing flow cytometry-based diagnostic tools from concept through validation and commercialization. The position requires a strong background in clinical assay development within a regulated IVD environment and offers the opportunity to shape long-term diagnostic innovation strategies. Travel across the UK, Spain, and wider Europe may be required.
Responsibilities:
1. Act as the technical and scientific authority for clinical flow cytometry assay and CDx development, guiding projects from feasibility to commercialization.
2. Lead assay design, optimization, analytical performance characterization, verification, and validation to ensure clinical relevance and compliance.
3. Assess project feasibility, identify risks, and propose solutions.
4. Ensure scientific rigor during technical and design reviews.
5. Oversee compliance with regulatory standards and documentation requirements.
6. Collaborate across functions to align on execution strategies and plans.
7. Mentor junior team members and facilitate training sessions to grow technical capabilities.
8. Represent the organization at conferences, scientific meetings, and with regulatory agencies.
9. Incorporate customer perspectives into product development processes.
10. Stay updated on emerging trends and identify promising new technologies or assays.
11. Contribute to business and portfolio strategy, supporting investment decisions and external engagements.
Key Skills and Requirements:
12. Advanced degree (Master's, MD, or PhD) in a relevant scientific field.
13. Extensive experience in developing and commercializing clinical assays, ideally within an IVD or CDx environment.
14. Strong expertise in flow cytometry applications and data analysis.
15. Proven track record in clinical diagnostic R&D within an industry setting.
16. Analytical and technical problem-solving skills.
17. Ability to work effectively in cross-functional and geographically diverse teams.
18. Excellent verbal, written, and presentation skills.
19. Experience engaging with regulatory bodies and understanding regulations related to IVD and medical devices (e.g., 21 CFR, CE-IVD, ISO 13485).