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Director, Clinical Pharmacology

Empresa: AbbVie
Tipo de emprego: Tempo integral

Job Description
As a Director within the Clinical Pharmacology Neuroscience Group at AbbVie, you will lead clinical pharmacology programs in the Neuroscience/Psychiatry drug development area. You will have a seat at the table within asset teams to influence, decide, and recommend key clinical pharmacology strategies and information. You will be responsible and accountable for a variety of programs across the drug development spectrum, ranging from first in human through approval, including life cycle management and post approval commitments/requirements. You will be expected to communicate/present and lead key Clinical Pharmacology information/strategy to senior and executive management, regulatory agencies, and external peers. In your role, you will lead strategic planning for drug development activities and projects to achieve departmental strategies, goals, and objectives. Utilizing scientific expertise to provide appropriate interpretation of data to relate implications of results to asset teams and management. You will serve as liaison to other departments/divisions for any study/project needs, influence and strategically manage linkages across businesses and understand the impact of business decisions and solutions. You will be expected to lead teams within Clinical Pharmacology and be accountable for effective performance of the teams.
Responsibilities
Independently leads Clinical Pharmacology/PK/PD activities and multiple major projects. Assists asset teams and R&D senior management in the selection of action plans that best meets drug development business objectives.
Identifies issues impacting multiple complex projects and leads issue resolution. Conducts risk assessments and leads the function in development of contingency plans. Assures project remains in alignment with strategic objectives.
Provides overall clinical pharmacology timelines to assess portfolio opportunities. Negotiates with other functional areas on project outcomes and deliverables to meet conflicting demands (time, cost, quality/performance).
Provides expert scientific and strategic consultation to R&D teams, Regulatory, and all levels of management on critical decisions and development plans. Connects scientific, regulatory, and business implications from multiple teams. Influences and strategically manages linkages across businesses and understands the impact of business decisions and solutions.
Responsible for critically evaluating technical, scientific aspects of all AbbVie projects along with CLINICAL PHARMACOLOGY management. Reviews clinical protocols and scientific reports for regulatory filings and anticipates regulatory questions. Leads CLINICAL PHARMACOLOGY regulatory documents writing, submission and response to Regulatory agency comments.
Independently conducts due diligence assessments, summarizes results and represents CLINICAL PHARMACOLOGY on business development teams.
Identifies and develops process improvement initiatives and reviews recommendations with management for approval and sponsorship.
Responsible for leading efforts to develop departmental goals. Makes strategic clinical PK/PD decisions for the department. Provides leadership on strategic clinical pharmacology and drug development.
Manages personnel including development, mentoring, and effective delegation.
Leads teams within department, across CLINICAL PHARMACOLOGY and across functions. Responsible for leadership of cross-functional teams and accountable for effective performance of the team. Actively manages project team behaviors, mediates internal team disputes, and facilitates establishment of healthy and high performing teams.

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