Associate Principal Scientist, Clinical Research

** 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.

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* Education:

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* + 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

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* Required Skills:

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* 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

** Preferred

Skills:

*
* Current Employees apply HERE ($6687.htmld)

Current Contingent Workers apply HERE ($4020.htmld)

** 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  ()  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.  

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