Biomarker Diagnostics Operations, Associate Principal Scientist, Clinical Research

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 as needed to enhance the efficiency and efficacy of the translational biomarkers and diagnostics

• Continually survey the internal and external environment for trends, risks, gaps and opportunities and ensure your teams meets new challenges and opportunities

Minimum education required:

• Bachelor’s in life sciences or related field and eight (8) years of relevant experience

• Master’s or higher degree in life sciences or related field and five (5) years of relevant experience

Required Experience and Skills:

• A minimum of five (5) years of drug discovery experience, including late-stage clinical trial experience

• Experience in biomarker and diagnostic development

Preferred Experience and Skills:

• Five (5) years of experience in a GCP/GLP or CAP/CLIA lab environment

• Formal Project Management certification or training

• Regulatory and filing experience

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geo