Job Description

AbbVie strongly believes in the importance of identifying patients who are most likely to benefit from the medicines that they develop and commercialize. To this end, AbbVie has established and expanded core capabilities in Precision Medicine (PMed), encompassing clinical trial management, translational medicine and companion diagnostics. Within PMed, the Biomarker Program Management (BPM) team connects science and operations to manage biomarker research for multiple Phase 1-3 clinical trials. We are seeking an experienced and highly motivated individual who will employ operational and logistical strategies to ensure clinical trials are executed with quality and efficiency, on-time, within budget, and meet objectives. The successful candidate will have a proven track record of clinical trial experience and decision-making to achieve these objectives, including scientific expertise, strategic thinking, a patient-oriented mindset, team building and cross-functional collaboration.

Responsibilities:

Manage biomarker operations and logistics to support the clinical trial schedule, ensuring data are ready for analysis per timeline. Resolve or escalate biomarker study-related issues with PMed Lead or BPM Subject Matter Expert (SME).

Responsible for relevant biomarker content in clinical study documents and associated systems (including clinical trial blueprint/protocol, informed consent forms, eCRFs, CSRs, etc). Responsible for generating study related training materials for the study team, study sites and vendors for each trial. Ensure consistency across programs.

Manage EC/IRB biomarker related inquiries, ensuring consistent responses across studies while maintaining AbbVie biomarker standard language and study timelines. Work with non-PMed areas to improve cross-functional processes.

Manage biomarker vendor selection and scope, managing contract execution and vendor oversight in compliance with AbbVie’s procedures and applicable regulations. Work with Contracting, Procurement or other AbbVie resources to improve contracting efficiency and reduce costs across PMed.

Responsible for the accurate forecasting and tracking of study costs associated with sample and results management, bioanalytical assays, logistics and shipping.

Identify and resolve and/or escalate study-related issues and risks. Assist other team members to resolve risks.

Conceive and spearhead efforts to improve processes within and external to PMed. Responsible for ensuring BPM training materials are current. Lead training for new PMed members for some sections of the Process Guides.

Oversee sample analysis and data transfer tasks, ensuring timely sample shipments to vendors and/or storage sites and that the data are transferred to the correct databases. Oversee sample management, storage and/or destruction, per requirements. May work with or manage a Sample Operations Manager with responsibility for these tasks.

Understand and ensure the biomarker strategy is implemented in trial documents and processes.

Apply and adhere to ICH/GCP, biorepository procedures, biosample management best practices and ethical guidelines. Ensure appropriate documents are added to the Trial Master File.

Provide leadership and mentoring for team members; responsible for developing the expertise of team members. May manage contract or FTE, as needed. Set a positive and motivating work environment that encourages mutual respect, innovation and accountability at all levels. Balance multiple priorities in a fast-paced, team-based environment and set priorities for self and reports per Department needs.