Head of Product Development – In Vitro Diagnostics

2 weeks ago

Belfast, United Kingdom HIRANI Full time £125 - £150

Head of Product Development – In Vitro DiagnosticsARC’s purpose is to expedite access to precision medicine clinical trials for patients globally. We fulfil our purpose through our dedicated team of experts with unparalleled domain knowledge, and the important relationships we have developed with our global clients.The information below covers the role requirements, expected candidate experience, and accompanying qualifications.We are a Belfast-based Clinical Research Organisation that specialises in delivering compliance excellence for companies in the precision medicine sector. We support many of the world’s leading pharmaceutical R&D companies in implementing unapproved diagnostics in their clinical development programmes for patient selection or stratification, working as a strategic and integrated expert partner, taking full sponsor ownership of the IVD study being conducted in parallel with our clients’ IND/IMP trial.ARC’s team of experts cover IVD regulatory compliance, study design and approvals, quality assurance including vendor due diligence and management along with a team of clinical research experts who manage the IVD study, ensuring it is conducted in compliance with local and global GCP, and that the biomarker data is robust and reliable.To further support our growing client base and to expedite patient access to life-saving experimental medicines, ARC has developed and launched our SaaS platform, ARC360. ARC360 is transforming how organisations access regulatory intelligence and tailor study-specific information for using in vitro diagnostics to select and manage patients in IND trials. Powered by cutting-edge technologies and supported by a team of regulatory, quality, and clinical operations experts, ARC360 is designed to accelerate the initiation of complex clinical trials.ARC Regulatory is seeking a dynamic Head of Product Development – IVD to lead the transition of diagnostic products from Research Use Only (RUO) to Investigational Use Only (IUO). This senior role offers the opportunity to shape product strategy, drive assay development, and manage cross-functional initiatives with Regulatory, Clinical, QA, and Lab teams.Key Responsibilities· Lead end-to-end IVD development from RUO to IUO.· Define product roadmaps and oversee assay design, validation, and tech transfer.· Ensure compliance with ISO 13485, FDA 21 CFR Part 820, IVDR, and ISO 14971.· Inspire cross-functional teams and collaborate with internal and external stakeholders.· Oversee project timelines, budgets, and regulatory readiness for clinical trials.Qualifications· PhD/MSc in Biological Sciences or related field.· 5+ years in IVD or life sciences product development.· Proven experience in regulatory and clinical readiness for IVD products.· Strong knowledge of design control, quality systems, and assay validation.Preferred· Experience with companion diagnostics or LDT strategies. xpwpeyx · Familiarity with digital health or SaMD.#J-18808-Ljbffr

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