Associate Director, Clinical Operations

2 months ago

South San Francisco, United States Alumis Inc. Full time

Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. 

 

The Associate Director of Clinical Operations plays a pivotal role in overseeing the planning, coordination, and execution of global clinical trials. This position ensures adherence to project milestones, maintains fiscal responsibility, and upholds quality standards in compliance with ICH/GCP guidelines, regulatory mandates, and internal SOPs. The role involves developing and implementing study execution strategies and providing leadership to direct reports. 

  

The Associate Director fosters a supportive environment, encouraging authenticity and open communication. Committed to science and thoughtful risk-taking, the Associate Director collaborates across teams to find innovative solutions to technical and business challenges. They proactively identify risks and implement mitigation strategies, driving success in clinical operations with a strategic vision and teamwork. 

  

Key Responsibilities:

  • Lead clinical operations for assigned programs, ensuring compliance with GCP, ICH, and applicable regulations. 
  • Oversee global studies, providing direction to Clinical Trial Managers and CRO Study Teams. 
  • Contribute to Clinical Development planning and strategies. 
  • Lead CRO selection and management, oversee investigator recruitment and selection, study start-up, enrollment, data collection, and drug projections. 
  • Develop project timelines to meet departmental and corporate goals. 
  • Identify and implement mitigation strategies for study risks. 
  • Track KPIs for assigned trials, including clinical reviews and data query resolution. 
  • Provide senior management with timely updates on progress and changes in scope. 
  • Oversee the preparation and content of investigator meetings. 
  • Coordinate site outreach and enrollment efforts. 
    • Communicate regularly with key stakeholders, including Regulatory Affairs, Biostatistics, Data Management, Clinical Supply, Clinical Research, Legal, and Finance. 
    • Contribute to clinical study reports, Investigator's Brochures, protocols, and other regulatory documents. 
    • Ensure the Clinical Trial Master File is updated and inspection-ready. 
    • Assess enrollment feasibility across different indications. 
    • Lead or co-lead the development of clinical documents and study-related plans. 

        

      Professional Experience / Qualifications: 

      • Up-to-date knowledge of industry practices, outsourcing, and GCP system requirements. 
      • Strong collaborative skills and the ability to build relationships across departments. 
      • Documented training in FDA Regulations, GCP, and ICH guidelines. 
      • Excellent communication and writing skills. 
      • Effective influencer and relationship builder. 
      • Problem-solving abilities and good judgment. 
      • Detail-oriented. 
      • Experience managing and developing direct reports. 
      • Willingness to travel domestically and internationally (10-15%). 
      • Regulatory authority inspection experience is a plus. 

          

        Preferred Education: 

        B.A. or advanced degree in biological sciences or a related discipline. 

          

        Preferred Experience: 

        At least 10 years of experience in clinical operations within biotech, pharmaceutical, or CRO environments, with 5 years of experience managing global clinical trials. Experience in early and late phases of development and immune-mediated diseases. 

          

        Preferred Computer Skills: 

        Proficiency in Microsoft Office (Word, Excel, Outlook), Smartsheet, electronic TMF, and electronic clinical technologies. 

          

        Alumis Values: 

        • We Elevate 
        • We Challenge 
        • We Nurture 

            

          This position is located in South San Francisco, CA, with the expectation of being in the office 3 days a week, Tuesday through Thursday. At this time we are not considering remote applicants.  

            

          The salary range for this position is $205,000 USD to $215,000 USD annually. This salary range is an estimate, and the actual salary may very based on the Company’s compensation practices.  


          Alumis Inc. is an equal opportunity employer. 

           

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