Associate Director, Biomarkers

During the first year, your goals will include:

• Planning, organization, and oversight of the entire lifecycle of clinical samples through collection, shipping, processing, storage and subsequent delivery for processing and analysis.
• Maintain oversight of all study biosample operational activities, including sample reconciliation, sample metrics and reporting. Ensure biosample strategy across multiple clinical programs is driven in accordance with the requirements of quality, ethical and regulatory guidelines, including ICH/GCP/GLP.
• Establish, implement, and maintain processes for sample management, including development of SOPs, for consistent practices across the clinical studies.
• Develop study-specific sample management plans, including vendor agreements, site training materials, and engagement with site personnel performing sample collection, processing, and shipping. Lead the development of a Sample Management Plan based on input from scientific and operational partners to implement biomarker operational strategies.
• Develop timelines and all internal resource needs for all biosample operational activities, ensure proper study plans and tracking.
• Lead interactive data visualizations and analytical tools for reporting metrics and trends and data QC and identify and communicate critical trends to study teams
• Participate in the identification, selection and oversight of laboratory vendors including drafting RFPs and defining scope of work in support of study objectives and goals
• Develop the strategy for a scalable sample storage, tracking and access
• Support sample analysis, data transfer, data reconciliation, and data review
• Provide study level updates to partners, clinical study teams and biomarker teams including sample collection, assay status and analysis updates

We'd love to hear from you if you have:

• BA/BS, Clinical Science or a related subject area preferred
• 5 + years industry experience in clinical research at a pharmaceutical, Biotech or CRO.
• Neuroscience and Oncology experience is helpful.
• 2+ years of experience in leading biosample operational activities in large, complex, and multi-center clinical studies.
• Direct experience in handling sample operations of various sample types, including tissue across multiple therapeutic areas.
• Working knowledge of ICH/GCP/GLP regulations and biosample management standard methodologies
• Ability to lead lab vendors and handle bio-sample management activities across multiple clinical trials
• Proven record of success in a cross-functional team environment.
• Clinical research experience in industry, ideally in Neuroscience and Oncology.
• Experience with vendor and CRO management.
• Proficient with sample data reporting, running metrics and understanding the overall quality and stability of study samples.
• Ability to comprehend and show scientific understanding in neuroscience space
• 2+ years of people management experience