Company 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.
Job Description
The Country Clinical Operations Head 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 COH 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
* Defines the country strategy and operational plans aligned with AbbVie's business priorities, Clinical Development Operations and affiliate objectives to position the country for near and long term success.
* Continuously assess country site footprint across all therapeutic areas, expanding where there are opportunities and needs to support the pipeline.
* Provides leadership, strategic direction and oversight for all country activities across all stages of the clinical trial ensuring high quality and scientific integrity of trial deliverables.
* Provides leadership and oversight to the clinical research team including performing accompanied visits, accelerating priority programs through close collaboration with internal and external stakeholders, conducting trend analysis and gap assessments, driving performance and addressing gaps to achieve country and site level KPIs, KRIs & metrics.
* Partners with internal stakeholders to drive insightful and impactful interactions and promote the value of the clinical research team through contribution to the R&D portfolio success.
* Accountable for the identification of resource needs, management of the allocated resources and timely hiring of clinical research staff to support clinical trials execution, maintaining team capacity aligned with organizational needs.
* Defines and implements the optimal team organizational structure to support the needs of the business, ensuring effective collaboration with key capabilities and roles.
* Accountable for ensuring adherence to applicable global and local regulations, ICH Guidelines and AbbVie Quality Management System, promoting a quality driven local organization.
* Ensures Inspection Readiness across all activities, promoting quality-driven initiatives and acting as the country expert for audit and inspection related processes.
* Accountable for functional budget planning and management, ensuring accurate budgets and forecasts, working closely with finance counterparts.
Qualifications
* Education: Bachelors or equivalent degree, health related (Medical, Scientific, Nursing, Pharmacy) preferred.
* Fluent in English language; German language would be an advantage.
* 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 processes.
* At least 2 years of experience in line management of staff including acquisition of talent, performance management, growth and development.
* Proven track record in project management, strong planning and organizational skills and a high level of adaptability.
* Experience in setting and driving the strategy and leading the management and completion of global trials assigned to the country/ies.
* Strong leadership competencies and robust experience in leading teams through change.
* Proven leadership skills in a cross‑functional, matrix environment, with ability to influence and align key stakeholders.
* 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.
* Acts with integrity in accordance with AbbVie code of business conduct and leadership values.
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.
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