Therapeutic Area Lead, Site Management & Monitoring
To enable AbbVie's emergence as a world class R&D organization, the Global Site Management and Monitoring (SMM) Therapeutic Area Lead plays a leadership role accountable for driving the business of SMM by providing therapeutic area(s) strategic oversight and direction; operating in over 60 countries with responsibility for the on time, within budget and quality delivery of the TA pipeline and Global Medical Affairs clinical studies. The role is responsible for developing and implementing a multi-year strategy, and serves as a single point of TA accountability across all SMM globally. As a member of the SMM leadership team the role will influence and aligns within R&D, Development Operations, Global Medical Affairs, and with other key stakeholders across the organization. Key Responsibilities Include:
- Accountable for the strategic and tactical planning and implementation of clinical programs for a therapeutic area for the work conducted by Clinical Field operations.
- Provides input and strategic direction into early planning and processes for determining timelines and budgets for global clinical studies and programs to ensure that plans are able to be executed as per commitments to the Corporation (and often Wall Street).
- Provides leadership from a SMM perspective, including competitive intelligence, into the decision making regarding the geo-strategy, clinical development plans, and clinical studies.
- Develops and implements strategies to manage changes to the therapeutic area(s) portfolio resulting in long-range, optimal global resource planning, identification and closing of gaps, timely training, and effective organizational change management.
- Develops strategy and establishes industry leading therapeutic area / disease specific capabilities and expert monitor staff.
- Provides strategic direction, drives a learning environment, and ensures continuous improvement in organizational performance by keeping an up to date knowledge of industry and future trends; and using innovative approaches, Key Performance Indicators (KPIs) and benchmarking to drive to achieve world class clinical execution. Ensures Clinical Field Operations and SMM business model is efficient and cost effective vs alternative models.
- Leads SMM quality management through risk-based thinking; active analysis of Key Risk Indicators/KPIs, metrics, and milestones; and management of risk through development of mitigation plans; Provides leadership in Quality by Design by contributing to the development of formal risk management plans at the program and study levels; Ensures health authority inspection-readiness at all times.
- Champions and ensures the use of critical path management, simplicity in process and approach, and elimination of bureaucracy.
- Bachelors or equivalent degree required.
- Minimum 12 years of Pharma‐related/ clinical research related experience.
- Minimum of 5 years applicable work experience in clinical research 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.
- Proven leadership skills in a cross-functional global team environment with experience in managing virtual teams and an ability to influence and align stakeholders, and be a model and driver of 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 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.
- Advanced degree (PhD, MD, MBA).