Associate Director, Study Manager, Immunology

MSD; North Wales (Montgomery County); Sur place; USD 142 000 - 224 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision insurance

401(k) retirement benefits

Paid holidays and vacation

Sick days and compassionate days

Résumé du poste

Merck & Co., Inc. in North Wales, PA, seeks a Clinical Trial Lead to steer the operational planning and execution of the Tulisokibart program across one or more trials.

You will lead a global, cross-functional team, coach junior members, ensure compliance with GCP/ICH, and drive milestones from study initiation through database lock, shaping strategy and governance.

Qualifications

• Bachelor's degree or higher with 9+ years in pharma, clinical drug development, project management, or medical field.
• Degree in life sciences preferred.
• Experience in conducting global clinical trials and regulatory-compliance knowledge is essential.

Responsabilités

• Oversee operational planning, feasibility, execution and conduct of clinical trial(s).
• Lead and direct teams in study planning, development, and execution elements.
• Collaborate with internal/external stakeholders to support trial objectives.

Connaissances

Clinical trial leadership

Regulatory knowledge (GCP/ICH)

Project management

Stakeholder management

Leadership

Communication skills

Formation

Bachelor's Degree, Life Sciences preferred

Master's Degree in Life Sciences

PhD/PharmD in Life Sciences

Outils

Microsoft Office (Excel, PowerPoint, Word, Outlook)

Description du poste

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

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

Location

The primary location for this posting is: USA - Pennsylvania - North Wales (Upper Gwynedd)

Salary Range

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.

Benefits

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 Information

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 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 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.

Job Posting Details

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.

Company Overview

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.

Equal Employment Opportunity

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.

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