There is an exciting opportunity within the Precision Medicine Biomarker Program Management (BPM) group at AbbVie. The Precision Medicine group uses advanced methods to discover biomarkers for use in clinical trials. Biomarkers may be used to confirm the molecular targets of a drug, predict efficacy, aid in patient selection and/or inform future drug development strategies. Biomarker research is an essential component for helping serve patient needs and furthering AbbVie’s innovative biopharmaceutical pipeline. AbbVie is hiring a Senior Biomarker Program Manager who will connect science and operations to implement and then manage biomarker research in multiple Phase 1-3 Oncology clinical trials. This role will employ operational and logistical strategies ensuring clinical trials are executed with quality and efficiency, on-time, within budget, and meet objectives. The project manager achieves these objectives via scientific expertise, strategic thinking, a global mindset and cross-functional collaboration. Responsibilities: Manage the biomarker operations and logistics to align with clinical trial schedule Co-manage with lead biomarker scientist to support regular updates to cross-functional stakeholders for each trial Responsible for relevant clinical study documents and associated systems (including trial blueprint/protocol, Informed consent forms, eCRFs, CSRs, etc.) Oversee EC/IRB biomarker related inquiries, ensuring consistent responses across studies while maintaining AbbVie biomarker standard language and study timelines Manage biomarker vendor selection and research scope; manage contract execution and vendor oversight in compliance with AbbVie's processes, procedures and applicable regulations Responsible for the accurate forecasting and tracking of study costs associated with sample and result management, bioanalytical assays, logistics and shipping as needed. Work with cross-functional areas to continuously improve processes. Responsible for generating study related training for the study team, study sites and vendors for each trial Oversee sample analysis and data transfer; ensure timely shipments to vendors and/or storage sites and that the data are transferred to correct databases. Responsible for sample management, storage, and/or destruction per requirements. Deposit biomarker related documents to the Trial Master File, ensuring that documentation standards are followed and are ‘inspection-ready’ Proactively identify and resolve and/or escalate study-related issues. Apply and adhere to ICH/GCP, bio-storage procedures, bio-sample management best practices and ethical guidelines Serve as a subject matter expert (SME) and resource for one or more processes in BPM Spearhead process improvement initiatives or improving efficiency as needed, as well as instructions and manuals for internal training purposes Manage multiple contract or permanent employees if needed Contribute to 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 work independently
Required: BS, MS, or PhD Degree with life sciences background, including biomarkers and typically 4+ (PhD), 9+ (MS), or 12+ (BS) years of project management, and/or clinical operations experience Expertise in MS Office applications including Excel, Word and PowerPoint Excellent oral and written communication skills in English Organization, attention to details and effective time management with an ability to adapt to changing priorities; excellent analytical and interpersonal skills Preferred: 2+ years direct clinical/biomarker operation experience, with exposure spanning initiation through study completion preferred Effective people management experience with proven ability to foster team productivity and cohesiveness Competent in application of standard business procedures (standard operating procedures, International Conference on Harmonization {ICH}, Global Regulations, Ethics and Compliance) Scientific background in biology or related. Knowledge of oncology, including biomarkers and 6+ years project management, and/or clinical operations experience is desirable Ability to work with minimal supervision Experience managing budgets, specifically providing accurate monthly Last Best Estimate (LBE) in coordination with vendor invoicing expectations. Experience holding meetings by teleconference and working with colleagues remotely Effectively work in a cross-functional team environment and ability to interact with various levels within the organization as well as external vendors Project Management certification a plus This position is located at one of our offices in South San Francisco, CA, Waltham, MA, or Lake County, IL. We offer flexible work arrangements, allowing you to choose between a fully on-site schedule or a hybrid model, which includes three days per week in the office.
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