Sr. Scientist, Biomarker Operations, Project Management

Job Description

We are currently seeking a Senior Scientist within the Integrated Biomarker Operations organization to provide biomarker project management and operational expertise to support cross-functional clinical teams, ensuring the timely and efficient delivery of the biomarker operational aspects of each study.

This position will report into the Associate Principal Scientist of Project Management and will be based either at Upper Gwynedd, PA or Rahway, NJ site. You will have experience in clinical biomarker assay execution and demonstrated success in project management. As a key contributor to the clinical biomarker strategy, you will be accountable for planning, implementation, and execution of clinical biomarker specimen collection, testing and data delivery activities in clinical studies. The primary focus of this position is in oncology, although support of other disease areas may be required as therapeutic focus evolves.

The successful candidate will work closely with Biomarker leads, Assay scientists, Vendor Managers and Clinical team to ensure that critical timelines are meet by our vendors. You will also monitor Integrated Biomarker Operations processes, identify opportunities for improvement, and implement strategic solutions to ensure excellence in service delivery.

The selected candidate will have strong verbal and written communication skills and be expected to work independently in a highly collaborative and matrixed environment. You will excel under fast paced and fluid conditions and be a strong advocate for operational excellence.

Primary responsibilities include, but are not limited to:

• Collaborate closely with biomarker scientists and project teams to plan clinical trial biomarker set-up using logistical strategies to ensure efficient trial execution

• Be the operational partner to the Biomarker scientific leads to aid in implementing strategies that drive the biomarker program forward

• Participate as a co-author for drafting relevant biomarker sections of clinical study protocol

• Work closely with Translational Molecular Biomarker (TMB) Scientist to manage specimen collection, handling, shipping, and storage guidelines that align with the Biomarker plan and clinical study protocol

• Accountable for providing biomarker vendor assay statement of work and data transfer specifications to the clinical teams

• Work with data management to effectively transfer biomarker data to clinical data repository from external biomarker vendors

• Work with Clinical team and/or Central labs to design sample collection kits, laboratory manual, and specimen logistics for shipments to third party vendors

• Maintain and grow effective partnerships with external biomarker vendors and our Company's internal teams

• Coordinate sample and assay logistics and serve as a key point of contact with vendors/collaborators …