Senior Clinical Trial Manager, LUMUS Program

4 weeks ago

South San Francisco, California, United States BioSpace, Inc. Full time
Job Details

Alumis Inc. is a precision medicines company with a mission to transform the lives of patients with autoimmune diseases. Our goal is to fundamentally change the outcomes for these patients.

We are seeking an experienced Senior Clinical Trial Manager to join our LUMUS study team. LUMUS is a global, Phase 2 trial aimed at evaluating the efficacy, safety, and pharmacokinetics of our targeted Tyrosine Kinase 2 (TYK2) inhibitor therapy in adult patients with moderately to severely active, autoantibody-positive Systemic Lupus Erythematosus (SLE).

Responsibilities
  • Manage all day-to-day operations of global clinical studies on one or more clinical programs from initial study synopsis through final project deliverables.
  • Manage aspects of a clinical trial from start-up through completion, including writing protocols, informed consent documents, and contributing to clinical sections of Investigator Brochures.
  • Responsible for site and vendor feasibility, capabilities assessment, selection, management, and oversight.
  • Manage the implementation, on-time execution, and conduct of clinical studies, including contributing and tracking the development of budget items, milestones, and timelines.
  • Coordination of cross-functional study team members to ensure initiation and execution of the clinical study deliverables within approved budget and timelines.
  • Risk management and mitigation, including prioritization of competing tasks and issues to ensure program/study objectives are successfully accomplished on-time.
  • Provide recommendations in vendor identification/qualification/selection and oversight with proven track record of successful execution and study completion activities.
  • Contribute to or lead the systems set-up/management, including EDC, IWRS, Central Laboratories, specialty services.
  • Ensure data integrity through oversight of routine data reviews, query and resolution, consistency checks both internally and for independent data monitoring committees.
  • Effectively tracks and communicate program/study progress to Portfolio/Program Directors and Senior Management.
Requirements
  • At least 8 years of relevant experience in clinical operations.
  • Experience in both early and late phase of development preferred.
  • Comfortable with travel and able to travel up to 25% of the time as needed.
  • Demonstrated experience in core and technical aspects of initiating and managing phase 1-4 clinical trials.
  • Demonstrated experience in management of sites, CROs and vendor selection.
  • Excellent interpersonal and communication skills, with developing leadership attributes.
  • Success working in a matrixed environment.
  • Demonstrated experience in the application of US and Global Regulations and Guidance.
  • Experience in data collection, monitoring, cleaning, and analysis throughout clinical development.
  • Proficiency in Microsoft Office, electronic TMF, and electronic clinical technologies.

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