Associate Director, Biomarker Program Management

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.

The Precision Medicine (PMed) Immunology and Neuroscience organization at AbbVie uses advanced methods to discover biomarkers and implement translational strategies to advance AbbVie’s innovative Immunology and Neuroscience pipeline.

The Associate Director, Biomarker Program Management, leads a team within the Immunology and Neuroscience therapeutic area that connects science and operations to manage biomarker research for multiple Phase 1-3 clinical trials. This role provides vision for operational and logistical strategies to ensure clinical trials are executed with quality and efficiency, on-time, within budget, and meet objectives. The Associate Director achieves these objectives via scientific expertise, strategic thinking, a global mindset, team building and cross-functional collaboration. This role can be based in North Chicago, IL, Waltham, MA, or South San Francisco, CA.

Responsibilities

Lead team of Biomarker Project Managers and Sample Operations Managers to facilitate the implementation of PMed research into AbbVie clinical trials. Provide management and mentoring for team members, responsible for developing the expertise of team members. Set a positive and motivating work environment that encourages mutual respect, innovation, and accountability at all levels.; Assign approved programs and trials to team members and ensure team members are resourced, trained, and employed to start up, manage and close clinical trials. This includes partnering with PMed Biomarker Leads and being responsible for editing clinical documents, sample management, data management, cross-functional teams, budget management and strategy documents. Programs are executed to meet required timelines, budgets, and regulatory requirements. May directly manage key clinical projects within PMed.; Manage biomarker operations and logistics to support the clinical trial schedule. Proactively identify, resolve, mitigate, and/or escalate biomarker study-related risks and issues.; Ensure vendors are managed per AbbVie procedures including selection, contract execution and management. Assist in the management of Oncology budgets, ensuring accurate projections are provided to Finance monthly, quarterly, and yearly, adjusting as appropriate to keep actual variances low.; Help set Vision for Biomarker Program Management group that enables continuous improvement in processes and efficiency. Explore potential opportunities for expanding services and capabilities of BPM. Identify gaps and spearhead special development projects, as needed.; Serve as liaison with leaders of cross-functional stakeholders within AbbVie. Responsible for collaborating with personnel in other Precision Medicine groups to drive consistency within and between groups.; Apply and adhere to ICH/GCP, biosample storage procedures, biosample management best practices and ethical guidelines.

Requirements

Ph.D. Degree with 8+ years project management, life science and/or clinical trial experience or Master’s Degree with 10+ years project management, life science and/or clinical trial experience or Bachelor’s Degree with 14+ years of project management, life science and/or clinical trial experience; Excellent oral and written communication skills in English. Expertise in MS Office applications including Excel, Word, Project and PowerPoint.; Organization, attention to detail and effective time management with an ability to adapt to changing priorities. Excellent analytical and interpersonal skills. Experience interacting with various levels within the organization as well as vendors.; Proven success in running meetings, working collaboratively in a cross-functional environment, and driving for success; 3+ years of people management experience. Effective people management and leadership skills with a proven ability to foster team productivity and cohesiveness.; Preferred:; PMP certification desired.; Competent in application of standard business procedures (standard operating procedures, International Conference on Harmonization {ICH}, Global Regulations, Ethics and Compliance); Experience working in a quality control and regulatory-rich environment. Experience holding meetings by teleconference and working with colleagues remotely.; Scientific background and knowledge of biomarkers. Exposure to companion diagnostic development. Knowledge of image data and associated testing.; Key Leadership Competencies:; Builds strong relationships with peers and cross-functionally with partners outside of team to enable higher performance; 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 and manages innovation to reality; Thinks beyond the program being managed to the strategy and operations of the broader Precision Medicine organization and the Development division; Act as a thought leader and mentor for team members, seek to develop the skillsets of others