Senior Study Manager, Immunology

Clinical Trial Operations Lead

This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof in our Tulisokibart program. In this position, you will have the opportunity to demonstrate your leadership and technical skills as part of a global, cross-functional team. You will apply project management, communication, and collaboration skills in support of our clinical trials.

Job Responsibilities

Responsible for the operational planning, feasibility, and execution of a clinical trial

May serve as the clinical trial team lead

May lead team in key study planning, development, and execution elements (e.g., data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, preparation of status update reports, study close out activities)

Leads team for timeline management, risk identification and mitigation, issue resolution

May facilitate and collaborate with key internal/external stakeholders (e.g., study team, country teams, vendors, committees) in support of clinical study objectives

Accountable for managing any study specific partners and/or vendors

Core Skills

Demonstrated ability to drive and manage operational activities on clinical protocols. This position may represent the company through external partnerships, collaborations, and key strategic engagements. This includes the ability to:

Solid knowledge of clinical research regulatory requirements (e.g., Good Clinical Practice (GCP) and International Council for Harmonisation (ICH))

Ability to manage multiple competing priorities with good planning, time management and prioritization skills

Solid understanding of the principles of project planning & project management

Good analytical skills to drive operational milestones

Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division

Interact with key stakeholders across department, division, and company. Role requires a proactive approach and leadership driving toward study goals

Applying leadership skills to processes, leading meetings, and influencing peers in a matrix environment

Problem solving, prioritization, conflict resolution, and critical thinking skills

Strong communication, writing, and presentation skills

Intermediate knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.)

Education/Experience

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 pharmaceutical, clinical drug development, project management, and/or medical field experience -OR-

PhD/PharmD Degree

Degree in life sciences, preferred

Ideal candidate would have:

Experience in conducting global clinical trials, including trial initiation through database lock

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

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

Required Skills

Adaptability, Analytical Problem Solving, Clinical Development, Clinical Operations, Clinical Sciences, Conflict Management, Critical Thinking, Ethical Standards, Good Clinical Practice (GCP), Partner Relationship Management (PRM), People Management, Presentation Delivery, Process Improvements, Stakeholder Alignment, Strategic Thinking

Preferred Skills

Leadership, Prioritization, Problem Solving, Study Management