Atrium Therapeutics este o companie de biotehnologie aflată în etapa clinică, care dezvoltă medicamente bazate pe ARN pentru boli cardiace genetice și rare. Platforma sa de administrare cardiacă se bazează pe tehnologia conjugatelor anticorp-oligonucleotidă, pentru a direcționa terapiile cu oligonucleotide către mușchiul inimii. Portofoliul include ATR-1072 pentru sindromul PRKAG2 și ATR-1086 pentru cardiomiopatia asociată cu PLN, precum și programe de cercetare aflate în stadii timpurii pentru alte cardiomiopatii rare. Compania intenționează să depună o cerere de autorizare pentru un medicament nou destinat cercetării pentru ATR-1072 în a doua jumătate a anului 2026. Activitatea sa reunește terapiile ARN și cardiologia de precizie, iar programele de cercetare și dezvoltare se concentrează asupra afecțiunilor care afectează inima.
Senior Clinical Trial Manager, Remote (California)
Lead global clinical operations for Atrium Therapeutics’ RNA therapies targeting cardiomyopathies. Oversee CROs, vendors, budgets, timelines, compliance, and trial delivery.
Descriere
- Own clinical study operations, including CRO and vendor oversight, project plans, budgets, and resource allocation.
- Develop study operational plans and contribute to functional plans and processes.
- Oversee CROs, vendors, and sites to maintain GCP and regulatory compliance.
- Represent clinical operations on cross-functional teams.
- Coordinate study timelines and budgets with the Clinical Operations Lead, internal leaders, and CROs.
- Manage study vendors and define deliverables and KPIs.
- Create study-specific training for site staff, CRAs, and vendors, and present at investigator and kick-off meetings.
- Oversee submissions and approvals with competent authorities and IRB or ethics committees.
- Design monitoring strategies that support study timelines and quality deliverables.
- Oversee eTMF structure, planning, and quality.
- Manage investigator selection, drug supply projections, study start-up, recruitment and retention, data collection, database locks, drug accountability, and closeout.
- Contribute to trial outlines, protocols, informed consent forms, and clinical study reports.
- Lead or support project plans, training, system builds, CRF designs, and user acceptance testing.
- Identify and resolve issues and risks with cross-functional teams and service providers.
- Work with data management and CRAs to maintain data quality and meet cleaning timelines.
- Conduct clinical data reviews, including generating queries as needed.
- Contribute to process improvements, initiatives, and SOPs.
- Guide and mentor junior team members.
- Escalate CRA performance and site compliance concerns.
- May manage direct reports.
Cerințe
- Bachelor’s degree, preferably in life sciences or an equivalent field.
- At least 8–10 years of clinical operations experience.
- Experience managing a CRO and a complex study as a Clinical Trial Manager or in an equivalent role.
- Global Phase I–III clinical trial experience.
- Rare disease experience required; cardiovascular experience is a plus.
- Inspection readiness and inspection experience are advantageous.
- Strong attention to detail and organizational skills.
- Excellent oral and written communication, analytical, and project management skills.
- Ability to build and sustain collaborative relationships with internal and external stakeholders.
- Ability to manage competing priorities, handle conflict and obstacles, and work in a fast-paced setting.
- Ability to learn and use technical applications quickly.
- Experience with Smartsheet, MS Excel, or equivalent tools preferred.
- Ability to manage budgets and forecasts.
- Prior auditing experience preferred.
- Prior experience as a Clinical Research Associate (CRA) preferred.
- In-depth knowledge of ICH/GCP, regulatory guidelines and directives, drug development, and clinical research processes.
- Team leadership experience in a cross-functional matrix environment.
- Availability for approximately 10–15% national and global travel for meetings and conferences.
Beneficii
- Stock options.
- 401(k) with employer match.
- Medical coverage.
- Dental coverage.
- Vision coverage.
- Long-term disability coverage.
- Unlimited time off, including summer and winter breaks.
- Company-developed learning and development programs.
- Role-specific training provided by the industry.
- Education reimbursement program.