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 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:

　　PhD Degree with life sciences background, including biomarkers and 4+ years project management, and/or clinical operations experience

　　Master’s Degree with life sciences background, including biomarkers and 9+ years project management, and/or clinical operations experience

　　Bachelor’s Degree with life sciences background, including biomarkers and 12+ years 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

　　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 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 vendors

　　Project Management certification a plus

　　Key Leadership Competencies:

　　Builds strong relationships with peers and cross-functionally with partners outside of team

　　Learns fast, grasps the “essence” and can change course quickly when required

　　Raises the bar and is never satisfied with the status quo

　　Creates a learning environment, open to suggestions and experimentation for improvement

　　Embraces the ideas of others, nurtures innovation

　　Keywords: Biomarker operations, oncology, clinical trial operations, project management

　　Equal Opportunity Employer Minorities/Women/Veterans/Disabled

　　AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.