Senior Study Manager, Immunology
Merck & Co.
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Job summary
Merck & Co. seeks a clinical operations leader to oversee the planning and execution of clinical trials within the Tulisokibart program. You will guide cross‑functional teams and drive study milestones, timelines, and collaboration with vendors to meet study objectives.
Ideal candidates bring extensive experience in global trials, regulatory knowledge (GCP/ICH), and strong leadership capabilities to coordinate with country teams and external partners.
Qualifications
- Bachelor's Degree and 5+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience
- Master's Degree and 3+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience
- PhD/PharmD Degree
- Degree in life sciences, preferred
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 in support of clinical study objectives
- Accountable for managing any study specific partners and/or vendors
Skills
Education
Tools
Job description
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.-
- 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
- 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.)
- 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
- 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
- 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
- Leadership
- Prioritization
- Problem Solving
- Study Management
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
Learn more about your rights, including under California, Colorado and other US State Acts
We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
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
$117,000.00 - $184,200.00
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.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
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. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .
Regular
No relocation
No
10%
Not Applicable
1st - Day
No
N/A
09/24/2026
R415525
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