Associate Director, Study Manager, Immunology

• 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

• 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

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.

• Clinical Trial Management
• Gastroenterology Experience
• Regulatory Compliance (GCP, ICH)
• Project Management
• Leadership and Mentoring

• Clinical Trial Execution
• Operational Planning
• Protocol Development
• Data Analysis
• Problem-Solving

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

• Clinical Drug Development
• Immunology Trials
• Autoimmune Disorders
• Pharmaceutical Industry
• Global Clinical Trials

• Microsoft Office
• Excel
• Power Point
• Word
• Outlook