| Alzheon is a clinical-stage biopharmaceutical company committed to developing innovative medicines by directly addressing the underlying pathology of devastating illnesses, such as Alzheimer’s disease (AD) and other neurodegenerative disorders characterized by accumulation of toxic, misfolded proteins. Our lead Alzheimer’s clinical candidate, ALZ-801, is a unique oral, amyloid anti-oligomer agent entering Phase 3 for the treatment of Early AD patients with two copies of the ε4 allele of the apolipoprotein E gene (APOE4/4). Building on seven years of research in amyloid oligomer biology, and an evidence foundation of 2000 patients treated with the active ingredient of ALZ-801, Alzheon scientists have found a better way to block the harmful effects of brain proteins called soluble amyloid oligomers, now recognized as the key triggers of cognitive worsening seen in early AD. Our experienced and passionate drug development team is focused on applying precision medicine, cutting-edge disease biomarkers, brain imaging and unique biologic insights to advance therapies with the greatest impact for patients. We are seeking individuals with an entrepreneurial spirit to join our team and help make the first oral Alzheimer’s disease-modifying therapy a reality for patients and their families, in a few short years. Position Overview
Alzheon is seeking a world-class Director of Clinical Operations who gets excited by the idea of developing therapies for which there is an unmet medical need and is willing to roll up their sleeves and do what it takes to drive success. This is a once in a lifetime opportunity to take a leadership role in driving forward a Phase 3 study for what might be the first drug ever to treat and prevent Alzheimer’s disease. If you have deep experience in coordinating CROs, ensuring adherence to project timelines and budgets, and supporting compliance across multiple regulatory bodies across the world, this role might be a great fit for you. Job Description - Manages and reviews operational aspects of study, including study timelines and metrics, vendors and vendor reports, and budgets
- Provides study-specific training to clinical research staff, including CRO, CRAs, sites, and other contract personnel
- Attends and/or manages study specific meetings, participating in site visits as appropriate
- Ensures clinical trials are executed in compliance with ICH/GCP guidelines, regulations and applicable SOPs
- Reviews monitoring reports to ensure quality and resolution of vendor and site-related issues
- Reviews site study documents (e.g., site-specific informed consent, investigator contracts, site payments)
- Develops relationships with CROs, investigators and site staff
- Oversees CRO clinical monitoring activities (approval of visit report templates, monitoring plans)
- Provides operational leadership and expertise in the implementation and execution of clinical study programs with focus on large registrational Phase 3 trial
- Builds and supports relationships with key opinion leaders, principal investigators, CROs and vendors
- Responsible for assisting in the day-to-day management of the CROs running a large registrational Phase 3 program
- Uses operational expertise and scientific assessment to evaluate study feasibility: assess end point measurement options, and ensure the successful execution of studies
- Leads and contributes to the development of clinical SOPs where necessary
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