Associate Principal Scientist, Clinical Research

Merck & Co.; Upper Gwynedd Township (Montgomery County); Hybrid; USD 142,000 - 224,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits package

401(k) plan

Job summary

Merck & Co. is seeking an Associate Principal Scientist, Biomarker Operations to lead planning and execution of clinical-trial biomarkers across the pipeline, ensuring compliant biospecimen handling, assay execution, and data delivery.

You will partner with biomarker scientists and study teams to optimize biomarker workflows, co-author study protocol sections, and drive operational excellence across vendor collaborations and internal teams.

Qualifications

• Demonstrated project management experience.
• Proven experience in drug discovery and/or clinical research.
• Demonstrated ability to excel in fast-paced, evolving conditions and advocate for operational excellence.
• Excellent written and verbal communication; able to work independently in a collaborative, matrixed environment.

Responsibilities

• Collaborate with biomarker scientists and study teams to plan clinical-trial biomarker setup and logistics.
• Serve as the operational partner to Biomarker Leads, helping implement strategies.
• Co-author biomarker-related sections of clinical study protocols.
• Define and manage specimen collection, handling, shipping, storage, and processing requirements.
• Develop biomarker vendor statements of work and data-transfer specifications with clinical teams.
• Coordinate sample and assay logistics, issue resolution and risk mitigation.
• Transfer biomarker data from external vendors into the clinical data repository.
• Design sample collection kits, laboratory manuals, and specimen logistics for shipments to third-party vendors.
• Build partnerships with external biomarker vendors and internal teams.
• Identify and resolve conflicting stakeholders' needs to maintain alignment.
• Implement and improve streamlined workflows for efficiency and data quality.

Skills

Project management

Drug discovery

Clinical research

Communication skills

Education

Bachelor's degree

Master's degree

Tools

Power BI

Power Automate

Copilot

Job description

Job Description

Job Description: Associate Principal Scientist, Biomarker Operations

Role Summary

The Associate Principal Scientist, Biomarker Operations Project Management is responsible for planning and executing clinical-trial biomarkers across the pipeline, ensuring compliant, efficient biospecimen collection, assay execution, and data delivery. This role drives operational excellence, data quality, and compliance across the biomarker assay project lifecycle. The Associate Principal Scientist partners closely with scientific and operational colleagues to support a cohesive and agile team that delivers high-quality biomarker data for clinical trials and translational research. This job will support the pipeline across clinical trial stages and therapeutic areas.

Primary activities include, but are not limited to:

• Collaborate closely with biomarker scientists and study teams to plan clinical-trial biomarker set-up and logistics, enabling efficient study execution.
• Serve as the operational partner to Biomarker Leads, helping implement strategies that advance biomarker programs.
• Co-author biomarker-related sections of clinical study protocols.
• Collaborate with Translational Molecular Biomarker Scientists to define and manage specimen collection, handling, shipping, storage, and processing requirements aligned to the biomarker plan and clinical study protocol.
• Develop biomarker vendor statements of work and data-transfer specifications in partnership with clinical teams.- Work with clinical teams to coordinate sample and assay logistics, issue resolution and risk mitigation.-
• Partner with Data Management to transfer biomarker data from external vendors into the clinical data repository.
• Work with clinical teams and central laboratories to design sample collection kits, laboratory manuals, and specimen logistics for shipments to third-party vendors.
• Build and maintain effective partnerships with external biomarker vendors and internal teams within our company.
• Proactively identify and resolve conflicting stakeholders needs to maintain alignment and momentum.
• Implement and continuously improve streamlined workflows that maximize efficiency and data quality and reinforce a culture of operational excellence.

Education:

• Bachelor's degree (with ≥8 years of relevant experience), Master's degree or higher (with ≥5 years of relevant experience) in a scientific or technical field.

Experience and Skills

Required:

• Demonstrated project management experience.
• Proven experience in drug discovery and/or clinical research.
• Demonstrated ability to excel in fast-paced, evolving conditions and advocate for operational excellence.
• Excellent written and verbal communication skills, with the ability to work independently within a highly collaborative, matrixed environment.

Preferred Skills:

• Experience with using Microsoft Power BI, Power Automate, Copilot or other similar automation tools

Required Skills:

Biobank, Biomarker Development, Biomarker Discovery, Biomarker Identification, Biomarker Qualification, Biomarkers, Clinical Research, Clinical Trials Operations, Drug Research, Good Clinical Practice (GCP), Sample Handling, Translational Medicine

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.

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

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

Employee Status: Regular

Relocation: No relocation

VISA Sponsorship: No

Travel Requirements: No Travel Required

Flexible Work Arrangements: Hybrid

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): N/A