Associate Director, Study Manager, Immunology

Jobtailor; California (MO); On-site; USD 140,000 - 190,000; Full time

Job summary

Jobtailor seeks a Senior Clinical Trial Lead to drive strategy and execution across one or more trials. You will guide the clinical trial team, coordinate cross-functional activities, and ensure milestones are met with a focus on regulatory compliance and quality.

The role requires 9+ years in pharmaceutical/clinical drug development or related fields, with strong leadership, planning, and communication skills. Global trials experience is a plus and no visa sponsorship is offered.

Qualifications

• Bachelor's Degree and 9+ years of pharmaceutical/clinical drug development or PM experience.
• Master's Degree and 6+ years of relevant experience.
• PhD/PharmD and 2+ years of relevant experience.
• Life sciences degree preferred.
• Experience in Gastroenterology, Dermatology or Rheumatology, especially autoimmune/immune-mediated disorders.
• Experience conducting global clinical trials from trial initiation through database lock.
• Immunology-related trial experience is a plus.
• Knowledge of GCP/ICH regulatory requirements.
• Ability to manage priorities, delegate, and plan.
• Strong communication, writing and presentation skills.
• Demonstrated leadership in programs, meetings, and matrix environments.
• Proficiency in MS Office tools.
• No visa sponsorship.

Responsibilities

• Participate in strategy and lead planning and execution of one or more clinical trials in the program.
• Serve as Clinical Trial Team lead.
• Lead and direct teams through study planning, operational reviews, issue escalation and governance.
• Collaborate with internal and external stakeholders, including study teams, vendors, and committees.
• Liaise with partners, vendors, and vendor management teams.
• Review and provide clinical operations input on protocols and other documents.
• Serve as SME and participate on process improvement teams.
• Build and coach junior team members through mentoring and development opportunities.
• Potentially manage direct and indirect reports, including resource assignment and performance management.
• Represent the company through external partnerships, collaborations, and strategic engagements.
• Drive scientific activities on clinical protocols and operational milestones.

Skills

Clinical Trial Mgmt

Leadership

Regulatory Knowledge

Project Management

Stakeholder Collaboration

GCP/ICH Knowledge

Education

Bachelor's Degree

Master's Degree

PhD/PharmD

Tools

Microsoft Office Suite

Excel

PowerPoint

Word

Outlook

Job description

• Participate in strategy and lead operational planning and execution of one or more clinical trials in the Tulisokibart program


• Serve as Clinical Trial Team lead


• Lead and direct teams through study planning, development, operational reviews, issue escalation and mitigation, presentations, cross-functional meetings, and governance


• Facilitate collaboration with internal and external stakeholders, including study teams, subsidiary country teams, vendors, and committees


• Liaise with partners, vendors, and vendor management teams


• Review and provide clinical operations input on protocols and other clinical documents


• Serve as a subject matter expert and/or participate on process improvement teams


• Build and coach junior team members through mentoring and development opportunities


• Potentially manage direct and indirect reports, including resource assignment, professional development, and performance management


• Represent the company through external partnerships, collaborations, and strategic engagements


• Drive scientific activities on clinical protocols and operational milestones

Requirements

• Bachelor's Degree and 9+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience; OR Master's Degree and 6+ years of relevant experience; OR PhD/PharmD Degree and 2+ years of relevant experience


• Degree in life sciences preferred


• Highly preferred: experience conducting clinical trials in Gastroenterology, Dermatology or Rheumatology, especially autoimmune or immune-mediated disorders


• Experience conducting global clinical trials from trial initiation through database lock


• Experience managing and driving operational activities on protocols for immunology-related clinical trials


• Knowledge of clinical research regulatory requirements, including GCP and ICH


• Ability to manage competing priorities, delegate, and assign activities


• Ability to develop realistic short- and mid-range project plans


• Strong analytical, problem-solving, prioritization, conflict-resolution, critical-thinking, communication, writing, and presentation skills


• Demonstrated leadership in programs and processes, meetings, and matrix environments


• Proficiency in Microsoft Office or similar tools, including Excel, PowerPoint, Word, and Outlook


• No visa sponsorship

Core Competencies

Demonstrates expertise in leading clinical trials, particularly in Gastroenterology, Dermatology, and Rheumatology, with a strong focus on operational planning, stakeholder collaboration, and regulatory compliance. Proven ability to mentor and develop team members while managing complex project timelines and competing priorities.

Highest-signal resume keywords

• Clinical Trial Management


• Gastroenterology Experience


• Regulatory Compliance (GCP, ICH)


• Project Management


• Leadership and Mentoring

ATS Optimization Keywords

Hard Skills

• Clinical Trial Execution


• Operational Planning


• Protocol Development


• Data Analysis


• Problem-Solving

Soft Skills

• Communication


• Critical Thinking


• Conflict Resolution


• Presentation Skills


• Prioritization

Industry Keywords

• Clinical Drug Development


• Immunology Trials


• Autoimmune Disorders


• Pharmaceutical Industry


• Global Clinical Trials

Tools & Technologies

• Microsoft Office


• Excel


• PowerPoint


• Word


• Outlook