Associate Director, Study Manager - Atherosclerosis and Metabolism

Merck & Co.; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid holidays

Vacation and sick days

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking a leader to drive strategy and execution for one or more clinical trials. You will guide operational planning, build and coach teams, and coordinate with global stakeholders to ensure study success.

The role requires strong regulatory knowledge (GCP/ICH), proven leadership, and excellent communication. A biotech/pharma background and experience in trial management are essential.

Qualifications

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

Responsibilities

• Oversee operational planning, feasibility, execution and conduct of clinical trials.
• Serve as the Clinical Trial Team (CTT) lead.
• Lead study planning, development, and execution elements and governance.
• Coordinate with internal/external stakeholders (study team, country teams, vendors, committees).
• Liaise with partners, vendors and vendor management teams.
• Review and provide operational input into relevant clinical documents such as protocols.
• Act as SME and participate on process improvement teams.
• Build talent and coach junior team members; manage resources and performance.

Job description

Job Description

This position participates in the strategy and leads the operational planning and execution of one or more clinical trials. 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 (CTT) 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

• 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. Role 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

Required Skills

• Adaptability
• Analytical Problem Solving
• Clinical Data Management
• Clinical Study Management
• Collaboration
• Detail-Oriented
• Ethical Standards
• Good Clinical Practice (GCP)
• Stakeholder Alignment
• Strategic Thinking

Preferred Skills

• Process Improvements
• Program Management
• Project 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. 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.

Learn more about your rights, including under California, Colorado and other US State Acts

Salary

The salary range for this role is $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.

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.

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

10/17/2026