Senior Study Manager, Immunology

Jobtailor; California (MO); On-site; USD 120,000 - 180,000; Full time

Job summary

Jobtailor is seeking an experienced clinical trial leader to drive planning, execution and study conduct for immunology-focused programs.

You will lead cross-functional teams, manage timelines and data deliverables, coordinate country/site activities, and ensure regulatory compliance across sites and vendors while communicating clearly with stakeholders.

Qualifications

• Global clinical trials experience from initiation through database lock.
• Immunology-focused trial experience preferred (autoimmune/immune-mediated).
• Strong communication, writing and presentation skills.

Responsibilities

• Lead planning, feasibility, and execution of immunology trials.
• Serve as trial team lead and coordinate cross-functional activities.
• Manage timelines, risk, and issue resolution across sites and vendors.
• Collaborate with internal and external stakeholders and committees.
• Drive study milestones and operational goals.

Skills

Clinical Trial Management

Project Management

Regulatory Compliance (GCP, ICH)

Immunology Clinical Trials

Stakeholder Collaboration

Education

Bachelor's degree (life sciences preferred)

Master's degree (life sciences)

PhD/PharmD degree

Tools

Microsoft Office

Excel

PowerPoint

Word

Outlook

Job description

• Lead operational planning, feasibility, and execution of one or more clinical trials or significant aspects of trials in the Tulisokibart immunology program
• Serve as clinical trial team lead when needed
• Lead study planning, development, and execution elements, including data management deliverables, trial plans and timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, status reports, and study closeout
• Lead timeline management, risk identification and mitigation, and issue resolution
• Facilitate collaboration with internal and external stakeholders, including study teams, country teams, vendors, and committees
• Manage study-specific partners and vendors
• Represent the company through external partnerships, collaborations, and strategic engagements
• Lead meetings and influence peers in a matrix environment
• Drive operational milestones and study goals

Requirements

• Bachelor's Degree and 5+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR Master's Degree and 3+ years of such experience OR PhD/PharmD Degree
• Degree in life sciences preferred
• Experience conducting global clinical trials, including trial initiation through database lock
• Highly preferred: experience conducting clinical trials for Gastroenterology, Dermatology, or Rheumatology, especially autoimmune or immune-mediated disorders
• Experience managing and driving operational activities on protocols for immunology-related clinical trials
• Solid knowledge of clinical research regulatory requirements, including GCP and ICH
• Ability to manage multiple competing priorities
• Understanding of project planning and project management principles
• Analytical, problem-solving, prioritization, conflict-resolution, and critical-thinking skills
• Strong communication, writing, and presentation skills
• Intermediate knowledge of Microsoft Office or similar, including Excel, PowerPoint, Word, and Outlook
• No visa sponsorship
• 10% travel
• Valid driving license not required

Core Competencies

Demonstrates expertise in leading clinical trial operations, including planning, execution, and compliance with regulatory requirements. Proficient in managing cross-functional teams and driving project milestones in the immunology domain.

Highest-signal resume keywords

• Clinical Trial Management
• Project Management
• Regulatory Compliance (GCP, ICH)
• Immunology Clinical Trials
• Stakeholder Collaboration

ATS Optimization Keywords

Hard Skills

• Clinical Drug Development
• Data Management
• Trial Planning
• Risk Identification and Mitigation
• Operational Activities Management
• Analytical Skills
• Problem-Solving Skills
• Project Planning Principles

Soft Skills

• Strong Communication Skills
• Conflict Resolution
• Critical Thinking
• Prioritization Skills

Industry Keywords

• Clinical Trials
• Gastroenterology
• Dermatology
• Rheumatology
• Autoimmune Disorders
• Life Sciences

Tools & Technologies

• Microsoft Office
• Excel
• PowerPoint
• Word
• Outlook