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.
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
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
Has a robust understanding of the study design of Alzheimer’s disease protocols including rationale, end points, and patient populations
Able to leverages resources, expertise and knowledge across all aspects of clinical programs, including specific operational strategies for executing clinical studies globally
Able to lead clinical operations planning activities for clinical programs and translate strategic decisions into actionable operational plans, including proactive identification of work streams and dependencies, key risk indicators, resources and milestones and able to develop practical solutions to mitigate risk and address problems
Excellent electronic and communications skills, ability to use communication tools effectively and give presentations confidently
Must be proactive, self-disciplined and able to work independently
Must have experience managing and providing oversight to clinical studies outsourced to third party suppliers (CROs, central labs, eCOA vendors etc.) and be able to manage interactions between functional groups such as monitoring, data management, biostatistics, medical writing etc.
Ability to build and maintain relationships with clinical trial sites and investigators
Excellent computer skills including the ability to use project management programs and tools for the measurement and tracking of performance
Ability to travel as needed and when possible
Experience and Qualifications
Minimum of bachelor’s degree in a Life Sciences or Health related field. Advanced degree preferred
Minimum of 8 years’ experience in clinical trial execution in the biotech or pharmaceutical industry
Experience in managing international/global clinical trials including registrational Phase 3 studies
Demonstrated record of project management achievements, including innovative operations approaches to achieving project/program goals
Experience in Alzheimer’s disease a plus
Alzheon’s ALZ-801 is currently the only oral disease-modifying treatment in late-stage testing for Alzheimer’s disease. We believe that ALZ-801 has the potential to significantly slow or stop disease progression and even prevent the onset of symptoms.
Development of ALZ-801, a well tolerated new treatment, is based on seven years of Alzheon research into the biology of AD and data from 2000 patients treated with its active ingredient tramiprosate.
Using precision medicine principles, we are focusing first on high-risk APOE4/4 homozygous patients with Early AD, who are predicted to benefit most from a treatment like ALZ-801. Future research will expand to treatment of patients with only one copy of the APOE4 gene, and ultimately to prevention of AD onset.