Clinical Scientist
7 days ago
Liverpool
COMPANY OVERVIEW AIRNA is a biotechnology company with a mission to be the leading RNA editing company delivering precision therapies to patients with rare and common diseases. AIRNA is harnessing advances in genetics to develop transformative RNA-editing medicines that improve human health. Our proprietary platform is based on groundbreaking research by pioneers of the field and company co-founders Thorsten Stafforst (University of Tübingen) and Jin Billy Li (Stanford University) and enables optimal potency, safety, and delivery. AIRNA is advancing a robust pipeline of therapeutic candidates that are designed to provide functional cures for severe or chronic diseases by repairing harmful genetic variants or introducing beneficial variants promote optimal health. AIRNA has raised $245 million in financing from a world-class syndicate of investors including Arch Venture Partners, Forbion, Venrock Healthcare Capital Partners, RTW Investments, Nextech Invest, and ND Capital. We value teamwork, resilience, excellence, human, and health, and have a diverse team at both our headquarters in Cambridge, MA and our research operations in Tübingen, Germany. JOB OVERVIEW The Clinical Scientist supports the design, execution, and analysis of clinical trials that are part of AIRNA’s RNA editing platform. Working closely with Clinical Development, Clinical Operations, and external clinical trial site staff, the clinical scientist will ensure scientific integrity and operational excellence in AIRNA’s clinical trials. RESPONSIBILITIES Clinical Trial Design & Protocol Development • Assist in or lead the design of clinical study protocols and amendments, • Provide scientific and clinical input during trial conduct, • Monitor data for consistency, completeness, and potential safety/efficacy signals, • Collaborate with CROs, sites, and internal teams to resolve study-related issues, • Review clinical trial data in collaboration with data management and biostatistics, • Interpret data in the context of the disease, target, and competitive landscape, • Work closely with Clinical Operations, Medical Monitors, Pharmacovigilance, and Regulatory Affairs, • Participate in clinical development plan creation and updates, • Support preparation of INDs, NDAs, CTAs and other regulatory documents, • Provide input into safety review processes and risk-benefit assessments QUALIFICATIONS Education: • Strong knowledge of ICH GCP and clinical trial methodology, • Ability to critically evaluate scientific data and literature, • Strong communication skills (verbal and written), • Experience in rare disease, including pulmonary/hepatic diseases, • Familiarity with working with and supporting clinical trial sites for study start-up and recruitment, • Working knowledge of clinical trial site monitoring, • Ability to travel to clinical trial sites and build relationships with PIs and clinical trial site staff LOCATION • This is a remote position that will require travel to sites. A candidate based in Europe/UK is preferred.