Immunology Clinical Study Director

MSD Malaysia; North Wales (Montgomery County); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical benefits

401(k) retirement plan

Paid holidays

Job summary

Merck & Co., Inc. is seeking a Clinical Trial lead to drive the operational planning and execution of clinical programs within the Tulisokibart program.

You will coach teams, manage cross-functional collaboration, and ensure alignment with GCP/ICH standards. Ideal candidates bring strong leadership, regulatory knowledge, and the ability to influence stakeholders across global teams, vendors, and study partners.

Qualifications

• Experience in conducting clinical trials for Gastroenterology, Dermatology or Rheumatology, especially autoimmune or immune-mediated disorders.
• Experience in conducting global clinical trials, including trial initiation through database lock.
• Experience in managing and driving operational activities on protocols for immunology related clinical trials.

Responsibilities

• Responsible for the operational planning, feasibility, execution and conduct of clinical trial(s)
• Serves as the Clinical Trial Team lead
• Leads and directs teams in study planning, development, and execution elements (operational reviews, issue escalations, governance)
• Collaborates with key internal/external stakeholders (study team, subsidiary country teams, vendors, committees)
• Liaises with partners, vendors, and vendor management team
• Reviews clinical documents for input (protocol and related documents)
• May serve as SME and participate on process improvement teams
• Builds talent and capabilities of junior team members through coaching and development
• May include management of direct/indirect reports including resource assignment and performance management

Skills

Adaptability

Analytical problem solving

Clinical Development

Clinical Operations

Clinical Sciences

Conflict Management

Critical Thinking

Ethical Standards

Good Clinical Practice

Partner Relationship Management

People Management

Presentation Delivery

Process Improvements

Stakeholder Alignment

Strategic Thinking

Leadership

Prioritization

Problem Solving

Study Management

Vendor Management

Tools

Microsoft Office

Job description

Merck & Co., Inc. is seeking a Clinical Trial lead to drive the operational planning and execution of clinical programs within the Tulisokibart program.

You will coach teams, manage cross-functional collaboration, and ensure alignment with GCP/ICH standards. Ideal candidates bring strong leadership, regulatory knowledge, and the ability to influence stakeholders across global teams, vendors, and study partners.