Job Details

AbbVie Job Opportunity

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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio.

This person reports into the Therapeutic Area (TA) Director, Global Site Management and is responsible for managing 3 levels of Site Management Leads within a specified Therapeutic Area. Drives a cohesive site management strategy and planning, delivering on Clinical Site Management (CSM) execution plans for specific programs/indications as assigned. Influences, aligns, and collaborates within Clinical Development Operations (CDO) and cross-functionally to ensure successful strategic planning and consistent execution of CSM deliverables for assigned TA/programs. Accountable for resourcing, study assignments, onboarding, training, and performance/development for assigned Site Management Leads.

Responsibilities:

• Manages a team of ~7-10 Site Management Leads (3 levels) and is accountable for strategic direction and on-time delivery of assigned indication/program portfolio milestones for CSM in a world class manner, ensuring compliance and quality.
• Collaborates with other GSM Associate Directors to build and maintain a consistent TA framework for Site Management Leads to succeed given the right training, tools and expectations. Develops and deploys internal communication strategies and provides input into external communication across assigned TA portfolio.
• Works with cross-functional partners (e.g. Clinical Study Leadership (CSL) PL, CDSO PL, SSU Global and Area Directors, etc.) and CSM Area and Country leaders to incorporate CSM data driven strategic insights across assigned TA portfolio and to ensure alignment on implementation strategy and plans, in support of their assigned Site Management Leads.
• Accountable for providing strategic oversight of the assigned studies to support SMLs in issue resolution to ensure delivery of the milestones, acting as the point of escalation for project related issues and leading stakeholder management at the TA level.
• Conducts CSM project review of assigned programs/indications, by use of dashboards, KPIs, and other tools, identifying risk(s) across assigned TA portfolio and aligns with Clinical Study Leadership PLs, CSM Area and Country leadership on related mitigation and/or action plans.
• Represents CSM organization in governance bodies for Enterprise Priority programs and supports project review by providing TA/program level insights and asks from CSM teams across studies across assigned TA portfolio.
• Drives for operational excellence by ensuring that CSM lessons learned are shared, and that best practices and strategies are consistently leveraged within and across Therapeutic Areas. Leads innovative process improvements and ensures change management including development and implementation of more efficient and agile ways for CSM to provide oversight on meeting targets for site selection, site engagement, activation, enrollment, data collection, and cleaning.
• Accountable for Site Management Leads study assignments, onboarding, and training within assigned TA. Responsible to develop and supervise assigned Site Management Leads creating an inclusive and innovative environment where staff and studies will succeed, including enhancing CSM tools, processes, and communication.
• Responsible for contributing/developing and maintaining Site Management Lead processes and training materials; within and across TAs to ensure consistent application of Site Management Lead processes globally, as well as tailored updates to include special consideration per assigned TA.
• Represents GSM organization in cross-functional meetings and initiatives to improve end to end processes ensuring feasibility, efficiency, and agility for CSM, CDO, and Global Therapeutics. Maintains knowledge of ICH/GCP, regulatory requirements, AbbVie SOPs, and assigned Therapeutic Area.

Qualifications:

• Bachelor's Degree or equivalent, typically in a scientific or (para)medical field required. Minimum of 10 years of clinical research experience, including 3 years project management experience and/or 1 year of direct line management preferred, demonstrating a high level of core, technical, and leadership competencies through setting and driving strategy and leading a global team in the management and completion of multiple, complex clinical studies.
• Advanced working knowledge of ICH and GCP guidelines is required. Seamless collaborator and strong communicator with demonstrated ability to influence without authority easily builds relationships across geographic locations and gains cross functional alignment. Demonstrated ability to apply critical thinking and to think strategically, to drive operational execution, using data to drive business decisions.
• Proven leadership skills in a cross-functional global team environment, experience in managing remote/virtual teams, and an ability to influence and align stakeholders, while modeling and driving AbbVie's leadership attributes.
• Strong analytical and critical thinking skills to evaluate complex issues from multiple perspectives and drive smart decision making. Excellent interpersonal skills with the ability to communicate persuasively and with clarity, flexibility and adaptability to changing requirements, resourcefulness and creativity.
• Demonstration of successful managing, coaching, mentoring, and talent management globally. Expertise in drug development, operations, strategic and tactical planning and resource/budget planning across global geographies. Demonstration of successful execution of program in a fast?paced environment managing multiple priorities.
• Demonstrated good written and verbal communication skills including fluency in English. Excellent planning and organizational skills and the ability to work effectively and efficiently in a dynamic, fast-paced environment.
• Strong ability to create and deliver presentations. Advanced skills in Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft OneNote

Key Stakeholders:

Clinical Site Management (CSM) including Area Head Study Start-up, Area Head Site Management, Area/Region/country leadership, TA Director - Global Site Management Central Development Services

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.