Associate Principal Scientist, Biomarker Operations Full-time NEW

Associate Principal Scientist, Biomarker Operations Project Management

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. The primary focus is Immunology and Oncology; however, support of additional disease areas may be required as therapeutic focus evolves.

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 company teams.
• 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:

• 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.

Required Skills:

Biomarkers, Clinical Research, Clinical Site Management, Clinical Study Protocols, Clinical Trials, Clinical Trials Operations, Detail-Oriented, Ethical Compliance, Immunology, Oncology, Operational Excellence, Operations Management, Sample Collection, Scientific Writing, Specimen Collection, Stakeholder Relationship Management

Preferred Skills:

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. 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 and 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.

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday – Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

VISA Sponsorship: No

Travel Requirements: No Travel Required

Flexible Work Arrangements: Hybrid

Shift: Not Indicated

Valid Driving License: No

Hazardous Material(s): n/a

Job Posting End Date: 03/31/2026

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