Biomarker Diagnostics Operations, Associate Principal Scientist, Clinical Research
USA - New Jersey - Rahway
Job Description
Biomarker Diagnostics Operations, Associate Principal Scientist, Clinical Research
We are currently seeking an Associate Principal Scientist to manage biomarker diagnostic projects in the Translational Medicine’s Biomarker Operations department. You will work closely with scientific and operational teams to deliver on biomarker and diagnostic objectives, encompassing clinical protocol set-up through assay data generation and filing. You will be responsible for the strategic and tactical operations of your projects. This position will report into the Leader of the Diagnostic Operations group within the Translational Medicine department and be based either at our Company's Pennsylvania, New Jersey, or Boson site.
You will have experience in biomarkers and diagnostics and demonstrated success in leading teams to deliver the highest quality science in a timely, efficient, and compliant manner. You will have strong influencing, negotiation and communication skills and be expected to operate in a highly collaborative and matrixed environment. You will excel under fast-paced and fluid conditions and be a strong leader of an operational excellence culture.
Primary job responsibilities include:
Determine, design, communicate and track biomarker diagnostic logistics and planning needs for late-stage clinical trials: This involves assessing the requirements for biomarker implementation and execution and providing assay-related direction to operational teams for seamless integration of biomarker assays at vendors and our Company's labs
Foster collaboration with biomarker and diagnostic partners: You will work closely with scientists, regulatory experts, and clinical and biomarker operations teams to ensure alignment of requirements and logistics across clinical trial protocols
During the execution of clinical trials at vendors, you will work with vendors and internal stakeholders to actively identify, resolve, track and communicate any assay-related issues
Work with data management in the collection and monitoring of biomarker diagnostic data, ensuring integrity and quality throughout the trial
Collaborate with sample management groups for biomarker diagnostic research projects, ensuring compliance with relevant regulations and guidelines
Be accountable for efficient project execution by ensuring deliverables and timelines are clear, resources are appropriately planned and managed, communications within and external to the team are effective, risk management plans are in place, issue resolution is productive, information is accurately tracked and accessible, and compliance is adhered to at every stage
Contribute to filings and regulatory interactions as needed
Work closely with other operational groups to provide a streamlined and cohesive approach encompassing vendor, project, and sample and information management of molecular biomarkers and diagnostics
Identify, assess, and implement operational improvements …
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Hybrid Hybrid work Hybrid work model
Benefits/PerksBonus eligibility Flexible work arrangements Hybrid work Hybrid work model Inclusive environment Insurance Meetings Paid holidays Retirement benefits Separation benefits package Sick Days Vacation
Tasks- Collaboration
- Communication
- Communications
- Compliance
- Data Management
- Innovation
- Issue resolution
- Planning
- Project management
- Risk Management
Biomarkers Business Operations Clinical Clinical Research Clinical trials Collaboration Commercial Communication Communications Compliance Data Data Management Design Diagnostics Drug Discovery Excel Execution GCP GLP Inclusion Influencing Information Management Innovation Integration Issue Resolution Logistics Management Manufacturing Matrixed environment Monitoring Negotiation Operational Operational Excellence Planning Project Management Quality Regulatory Regulatory Compliance Research Risk Management Talent Acquisition Team Leadership Training Translational Medicine
Experience5 years
EducationBachelor's Business Certification Communications Life Sciences Management Master's Ph.D. Related Field Science
CertificationsProject Management Certification
TimezonesAmerica/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9