Senior Director of Clinical Operations

4 weeks ago


South San Francisco, California, United States Alumis Full time
Job Title: Senior Director, Clinical Operations

Alumis Inc. is a precision medicines company dedicated to transforming the lives of patients with autoimmune diseases. As a Senior Director of Clinical Operations, you will play a pivotal role in driving the management, oversight, and execution of our clinical programs.

Key Responsibilities:
  • Manage and implement clinical operational functions, allocating and directing internal resources and effectively outsourcing when necessary to achieve project goals in a timely manner.
  • Lead and participate in the development of critical study documents, such as protocols, ICFs, study manuals, investigator brochures, and clinical study reports.
  • Identify outsourcing needs and oversee the selection, management, and performance of CROs, vendors, and external consultants.
  • Promote a strong quality culture within Clinical Operations, ensuring clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/policies, and industry best practices.
  • Develop and execute resourcing plans to ensure adequate and appropriate monitoring of all trials.
Requirements:
  • Extensive experience in setting up and managing domestic and international early and late-phase clinical trials, either directly or through CRO/vendor management.
  • Proven ability to manage multiple projects and priorities.
  • Strong working knowledge of GCP/ICH guidelines.
  • Experience in developing and managing departmental and study budgets and timelines.
  • Excellent interpersonal skills with a demonstrated ability to effectively work with internal and external cross-functional groups.
Preferred Qualifications:
  • At least 15 years of Clinical Operations experience, including 10+ years in a management role and 5+ years in the field of autoimmune disease.
  • Higher/professional degree a plus.
  • Proficiency in Microsoft Office (Word, Excel, Outlook), Smartsheet, electronic TMF, and electronic clinical technologies.
What We Offer:
  • Competitive salary range: $270,000 USD to $285,000 USD annually.
  • Generous stock option grants for all employees.
  • Annual bonus program.
  • Health insurance premiums paid at 90% for employee, 80% for dependents.
  • Free access to Genentech Bus & Ferry Share program.
  • $100 monthly cell phone stipend.
  • Unlimited PTO for Exempt employees.
  • Free onsite gym and a kitchen stocked with yummy snacks and drinks.

We are a hard-working, collaborative team on a mission to transform patient's lives-- and we aspire to elevate, challenge and nurture one another along the way.



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