Senior Clinical Trial Manager
at Alzheon
Framingham, MA
(Remote until COVID restrictions ease)
Reports to: VP of Clinical Operations
Introduction
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 highly motivated Senior Clinical Trial Manager who will be on the front lines of our Phase 3 trial, helping drive the successful execution of potentially the first oral disease-modifying Alzheimer’s drug. If you are highly skilled at keeping complex deliverables on track, holding multiple parties accountable to their timelines, and filling the gaps wherever needed, this role might be a great fit for you.
Job Description
- Support the day to day operations of a multi-site, multi-country Phase 3 clinical trial being managed by a CRO
- Maintain contact with clinical trial sites as needed to ensure understanding of the protocol and adherence to timelines
- Develops relationships with CROs, investigators, and site staff
- Coordinates with CRO and other vendors to ensure adherence to project milestones, tracks metrics, attend study meetings as appropriate, and escalates issues as they arise
- Review all study documents, and ensures proper submission and communication to all relevant stakeholders
- Attends study specific meetings, participating in clinical 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)
- Participates in the development of clinical SOPs where necessary
Required Skills
- Has a thorough understanding of clinical research and good clinical practices
- Experienced in the different phases of clinical trials, prior experience as a CRA is helpful
- A robust understanding of the study design of Alzheimer’s disease protocols including rationale, end points, and patient populations is helpful
- Able to leverage resources, expertise and knowledge across all aspects of clinical programs, including specific operational strategies for executing clinical studies globally
- Able to execute against project plan, identifying and escalating issues as they arise
- Strong interpersonal skills, excellent teamwork, organizational, interpersonal, conflict resolution and problem-solving skills
- 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 4 years’ experience in clinical trial execution in the biotech or pharmaceutical industry
- Experience in managing international/global clinical trials including registrational Phase 3 studies
- Experience in Alzheimer’s disease a plus
Job Location
Framingham, Massachusetts (Remote until COVID restrictions ease)
Position Type
Full-time/Regular
Alzheon is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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