Description

ICompany Description

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. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Purpose

Describe the primary goals, objectives or functions or outputs of this position.

The Country Clinical Operations Manager is the key leader for Clinical Operations at the country level for both internal & external partners. Accountable for the strategic and operational management for clinical operations and clinical site management activities for the assigned country/ies. Responsible for leading the implementation of the corporate vision and objectives, operating across all therapeutics areas to support the execution of AbbVie's pipeline. The role is accountable for country clinical trial performance, providing strategic planning, oversight and direction of the country team to ensure on time, within budget and quality delivery of internally conducted clinical studies.

The Country COM is accountable to develop a highly collaborative framework with internal and external key stakeholders across the local and global organization to best position AbbVie in advancing clinical research and accelerating the transformation of science into best-in-class medicines.

Responsibilities

• Key leadership role for Clinical Operations in Taiwan & Hong Kong, supporting internal and external partners
• Accountable for strategic and operational management of clinical operations and clinical site management activities
• Leads country team to deliver on AbbVie's clinical trial pipeline-ensuring studies are delivered on time, within budget, and with quality
• Develops collaborative frameworks with stakeholders to accelerate clinical research and transformation of science into medicines
• Responsible for defining country strategy and operational plans, expanding site footprint, and providing oversight for all stages of clinical trial execution
• Provides leadership and oversight to the clinical research team, drives performance, identifies development opportunities, and manages KPIs/KRIs/metrics
• Partners internally to promote clinical research team's value and leads 'One R&D' collaboration
• Accountable for resource planning, hiring, and maintaining team capacity, organizational structure, and staff development
• Ensures adherence to global/local regulations, ICH Guidelines, and AbbVie Quality Management System, driving continuous improvement and compliance
• Ensures inspection readiness, acts as country expert for audit and inspection processes, and may host in-country inspections
• Manages functional budget planning, country feasibility, site selection strategy, and site footprint expansion

Qualifications

• Education: Bachelors or equivalent degree, health related (e.g. Medical, Scientific, Nursing, Pharmacy) preferred.
• Minimum of 5 years of work experience in clinical research, demonstrating a high level of expertise on study monitoring and management across multiple Therapeutic Areas, Study Phases and in fully cycle (startup to closeout) processes. Solid understanding of drug development process (and medical device preferred) and requirements such as GCP, ICH, etc. Robust knowledge of local clinical trial setting (regulatory and healthcare environment).
• At least 2 years of experience in line management of staff including acquisition of talent, performance management, growth and development, managing employee relations, coaching and mentoring of staff and teams preferred.
• Proven track record in project management, strong planning and organizational skills and a high level of adaptability in a dynamic environment with experience leading (within country or region) projects with competing deadlines.
• Experience in setting and driving the strategy and leading the management and completion of global trials assigned to the country/ies. Experience in functional budget planning (preferred), resource planning & assignment, quality management at country or regional level.
• Strong leadership competencies. Robust experience in leading teams through change, leveraging team contribution to support business strategies. Gives guidance and inspiration to their direct reports and teammates.
• Fosters an environment that promotes the sharing of ideas, information, and best practices (internal and external to the organization) to drive continuous improvement.
• Proven leadership skills in a cross-functional, matrix environment, with ability to influence and align key stakeholders, forge strong partnership where needed and promote seamless collaboration at all levels. Proactively responds to the needs of others and makes their own needs and business strategy known. Externally approaches stakeholders with customer service orientation in order to be perceived as a clinical study partner of choice.
• 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 in a succinct and comprehensive manner to colleagues at all levels. Engenders trust throughout the organization and seeks to grow and stretch key talent for future possibilities. Acts with integrity in accordance with AbbVie code of business conduct and leadership values.

Key Stakeholders

Internal stakeholders include, but not limited to, Medical Affairs, Regulatory Affairs, Quality, HR, Finance, and the Affiliate Management Team.

Additional Information

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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.htmlI