Summary of Position:
ArriVent Biopharma is looking for a talented and highly motivated Senior Manager / Associate Director, Biosample Operations lead. This person will partner with cross-functional teams, in particular the Translational Medicine, Clinical Pharmacology and Clinical Operations, to coordinate and oversee biomarker and PK samples management activities in clinical trials, including Biosample tracking, processing and execution of biosample testing strategies, and timely data generation and delivery.
The ideal candidate will have proven experience in oncology biomarker and PK sample management, execution of biomarker and companion diagnostic strategies, and vendor oversight, preferably including global late-stage clinical programs.
Reporting to Vice President of Translational Medicine, this position will help to establish, set the vision and strategic direction for the Biosample Management function.
The primary location of the team is in San Francisco Bay Area, California.
- Establish bio-sample management system for ArriVent’s clinical programs.
- Establish study-specific biosample flow, analysis and data management plan.
- Manage the execution of biosample analysis logistics and timelines, from sample collection and processing, shipment, testing, data transfer, and final sample disposition, in accordance to study protocol and under the highest standards of quality, ethics, and informed consent.
- Facilitate resolution of sample and data discrepancies internally and with external vendors
- Provide biosample metrics and status updates to teams as requested.
- Establish and perform real-time specimen tracking.
- Support biomarker and pharmacology teams as needed to provide information on technical and operational sample-related matters.
- Manage the lifecycle of biomarker samples to ensure that samples are used and/or stored appropriately per the associated ICFs.
- Manage sample inventories for samples transferred to long-term storage facilities.
- Draft and/or review documents that pertain to biosample collection, handling, and storage including lab manuals and ICFs.
- Review contracts for vendors responsible for sample processing, analysis and storage.
- Execute biomarker and companion diagnostic strategies, including timely biospecimen testing, data generation, and delivery.
- Oversee central laboratories to ensure biosample collection, processing and storage are properly implemented.
- Oversee testing labs to execute biosample testing, timely data generation and delivery.
Desired Skills and Experiences:
- At least 3-5+ years of biosample management experience at an oncology pharmaceutical/biotechnology company
- Experience in global late-stage oncology clinical trials, including China.
- Experience with biosample management tracking platforms and software.
- Demonstrated knowledge of bioanalytical assay methods related to oncology is preferred.
- Proven ability to efficiently and effectively manage multiple competing priorities and deliver results successfully.
- Highly organized, detail-oriented, and self-motivated; strong communicator and collaborator
- Strategic, independent and critical thinker who exercises independent judgment to identify and solve problems as well as make decisions.
- Central lab and vendor overseeing experience is preferred.
- Life sciences degree (BS or MS) in Scientific, Medical or Healthcare subject area required. Higher degree (e.g. PhD or PharmD) is desirable.