Senior Study Manager, Immunology

Merck; San Diego (CA); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

401(k) and benefits

Job summary

Merck in the United States is seeking a seasoned Clinical Operations Lead to plan and execute clinical trials within the Tulisokibart program. You will coordinate across global teams, applying project management, communication, and collaboration skills to drive study milestones and regulatory compliance.

The role requires leadership, cross-functional influence, and a strong background in GCP/ICH, with an emphasis on gastroenterology, dermatology, or rheumatology trials.

Qualifications

• Bachelor's Degree plus 5+ years pharma/clinical drug development experience, or

Responsibilities

• Lead operational planning and execution of clinical trials.
• Serve as clinical trial team lead when needed.
• Drive study planning, timelines, site selection, and status reports.
• Manage timelines, risks, issues, and mitigation plans.
• Collaborate with study teams, country teams, vendors, and committees.
• Oversee study partners and vendors.

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

Education

Bachelor's Degree + 5+ years experience

Master's Degree + 3+ years experience

PhD/PharmD Degree

Life sciences degree, preferred

Tools

Microsoft Office

Job description

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.

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

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.

Requirements

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

Salary

The salary range for this role is

$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.

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

• 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.

Requisition ID: R415525