My client is searching for a talented, resourceful, self-motivated and proactive Senior Clinical Biomarker Scientist to lead the implementation and execution of the project-related clinical biomarker strategy across an innovative neuroscience pipeline. This position will provide technical expertise for identification and selection of high-quality clinical biomarker vendors in conjunction with cross-functional study team members. Coordinate with contracting and budgeting teams to ensure vendor responsibilities are clearly defined. Manage oversight of clinical biomarker deliverables in adherence with data integrity, data specifications and regulatory requirements. Collaborate with clinical team members for development and finalization of key clinical study documents including protocols, case report forms, informed consent documents, and instructional manuals for clinical sites. Communicate with study investigators and clinical sites to ensure adherence to specific sample collection and processing for specialized clinical biomarker needs. The candidate is expected to be an active contributor to the cross-functional teams, providing technical expertise where appropriate and acting independently, within a matrixed clinical development organization. Additionally, the candidate should demonstrate strong verbal and written communication skills and be able to manage tight timelines.
Additional responsibilities include but are not limited to:
•Responsible for executing clinical biomarker plan in alignment with the project team's goals (for example, laboratory manuals, informed consents, analytical plans, and SOWs).
•Develop robust analytically validated assays per FDA Bioanalytical Method Validation Guidance to implement clinical biomarker analysis.
•Provide contract research laboratory oversight for development and validation of assays required for clinical biomarker testing (experience in developing diagnostic is desirable but not required).
•Coordinate with Clinical Operations team members to assure collection and shipment of biomarker clinical samples from the clinical sites/central laboratory to analysis laboratories.
•Coordinate with internal and external stakeholders (CROs/clinical sites) to address clinical specimen-related issues in a timely manner.
•Develop data transfer specifications by gathering input from translational science leads, data management, and data scientists to ensure delivery of high-quality clinical biomarker data transfer.
•Continuously evaluate newer, innovative technology platforms and applicability to clinical biomarker testing.
Primary Job Requirements
•MS/PhD in Biological Sciences with a minimum of 5 plus years' experience, leading clinical biomarker logistics and operations.
•Prior experience in developing robust analytically validated assays per FDA Bioanalytical Method Validation Guidance to implement clinical biomarker analysis.
•Prior experience in providing CRO oversight with regards to clinical biomarker testing and experience in pivotal clinical studies including in diagnostic development is not necessary but desirable.
•Outstanding organizational skills and capacity to prioritize multiple tasks
•Excellent people skills with the ability to efficiently interface with multiple groups including clinical operations, data sciences and external CROs.
•Experience in neuroscience and translational science is not required but strongly preferred.
•Embrace and model Ccompany core values.
•Travel: Less than 20%