Associate Director, Study Manager, Immunology

Merck & Co.; San Diego (CA); On-site; USD 142,000 - 224,000; Full time

Job summary

Merck & Co. seeks an experienced Clinical Trial Lead to drive operational planning and execution for one or more trials within our Tulisokibart program.

You will lead a global, cross-functional team and coach members in project management, communication, and collaboration skills for successful trial delivery. The role emphasizes leadership in protocol development, regulatory compliance (GCP/ICH), and stakeholder engagement across study teams, vendors, and country affiliates, with focus on

Qualifications

• Bachelor's Degree and 9+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience.
• Master's Degree and 6+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience.
• PhD/PharmD Degree and 2+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience.
• Degree in life sciences, preferred.

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., operations reviews, issue escalations, governance).
• Collaborates with internal/external stakeholders (study team, vendors, country teams, committees) to support clinical trial objectives.
• Liaises with partners, vendors, and vendor management teams.
• Reviews and provides clinical operations input into relevant clinical documents such as the protocol.
• May serve as SME and participate on process improvement teams.
• Builds talent and capabilities of junior team members through coaching and development opportunities.

Skills

Clinical Operations

GCP & ICH

People Management

Stakeholder Management

Leadership

Communication

Problem Solving

Planning & Scheduling

MS Office

Vendor Management

Education

Bachelor's Degree

Master's Degree

PhD/PharmD

Life Sciences Degree preferred

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.)

Education/Experience

• 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

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. Please click here if you need an accommodation during the application or hiring process.

Equal Employment Opportunity Statement

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

Primary Location

USA - Pennsylvania - North Wales (Upper Gwynedd)

Compensation

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:
$142,400.00 - $224,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 .

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

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

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:

10/25/2026

*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.

Requisition ID:

R415524