Associate Director, Study Manager, Immunology
Merck & Co.
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Benefits offered by this job
Job summary
Merck & Co. is seeking a senior clinical operations leader to drive strategic planning and execution of complex clinical trials. You will lead a global, cross-functional team, coach talent, and ensure programs align with regulatory standards and study goals.
The role emphasizes interaction with internal and external stakeholders, oversight of study governance, and ongoing process improvement to advance gastroenterology, dermatology, or rheumatology programs.
Qualifications
- Bachelor’s degree or higher in life sciences or related field.
- Advanced project management and clinical development experience.
- Experience with regulatory requirements (GCP/ICH) and cross-functional leadership.
Responsibilities
- Lead operational planning, feasibility, execution of clinical trials.
- Act as Clinical Trial Team lead and coordinate cross-functional teams.
- Collaborate with stakeholders, vendors, and country teams to meet trial objectives.
- Mentor and develop junior team members and manage resources.
Skills
Education
Tools
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.
- 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
- 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.)
- Bachelor's Degree and 9+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience -OR-
- Master's Degree and 6+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience -OR-
- PhD/PharmD Degree and 2+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience
- Degree in life sciences, preferred
- 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 lockExperience 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
- Vendor Management
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
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.
$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.
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 .
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
Regular
No relocation
No
10%
Not Applicable
1st - Day
No
N/A
09/24/2026
R415524
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