Associate Director, Study Manager, Immunology

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

Job Description

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

Job 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 key study planning, development, and execution elements (e.g. operational reviews, issue escalation/mitigations, presentations at Sr Management meetings, program level cross functional meetings and governance)
• Responsible for facilitating and collaborating with key internal/external stakeholders (study team, subsidiary country teams, vendors, committees, etc.) in support of clinical trial objectives
• Liaises with partners, vendors, and vendor management team
• Review and provide clinical operations input into relevant clinical documents such as the protocol and other documents as appropriate
• May serve as a subject matter expert and/or participate on process improvement teams
• Builds talent and capabilities of junior team members through proactive coaching, mentoring and development opportunities
• May include management of direct/ indirect reports including assignment of resources, professional development, and performance management

Core Skills

• Demonstrated ability to drive and manage scientific activities on clinical protocols
• This position may represent the company through external partnerships, collaborations, and key strategic engagements
• Strong knowledge of clinical research regulatory requirements (e.g., Good Clinical Practice (GCP) and International Council for Harmonisation (ICH))
• Proven ability to manage competing priorities and effectively delegate and assign activities to meet the business needs
• Ability to develop short and mid-range project plans that are realistic and effective at meeting goals
• Strong 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.
• Roles requires a proactive approach, strategic thinking and leadership driving toward study goals
• Demonstrated leadership skills in programs & processes, leading meetings and influencing peers and direct/indirect reports in a matrix environment
• Problem solving, prioritization, conflict resolution, and critical thinking skills
• Strong communication, writing, and presentation skills
• Proficient knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.)

Ideal candidate would have:

Highly Preferred

• 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 clinicaltrialjobs

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
• Vendor Management

US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts

San Francisco Residents Only

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.

Los Angeles Residents Only

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

The salary range for this role is $142,400.00 - $224,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

• Annual bonus and long-term incentive, if applicable
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: 10%

Flexible Work Arrangements: Not Applicable

Shift: 1st - Day

Valid Driving License: No

Hazardous Material(s): N/A

Job Posting End Date: 09/24/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.