Director, Clinical Pharmacology (Oncology)

Job Description

Communicates/presents key Clinical Pharmacology information/strategy to senior and executive management, regulatory agencies, and external peers. Leads strategic planning for drug development activities and projects to achieve departmental strategies, goals, and objectives. Utilizes scientific expertise to provide appropriate interpretation of data and relates implications of results to management. Serves as liaison to other departments/divisions for any study/project needs. Influences and strategically manages linkages across businesses and understands the impact of business decisions and solutions. Leads teams within Clinical Pharmacology and Pharmacometrics and accountable for effective performance of the teams.

Responsibilities

• Independently leads Clinical Pharmacology/PK/PD activities and multiple major projects.
• Assists 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 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, Regulatory, and all levels of management on critical decisions and development plans.
• Connect scientific, regulatory, and business implications from multiple teams.
• 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 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.

Qualifications

• PhD with typically 9+ years of experience or PharmD with typically 11+ years of experience in a relevant field
• Master's Degree in Science or related field with typically 17+ years of related work
• Bachelor's Degree in Science or related field with typically 19+ years or more of related work
• Relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters
• Excellent interpersonal skills
• Advanced knowledge and experience in multiple therapeutic and/or functional areas
• Experience across range of development phases
• Recognized as an expert with global knowledge of AbbVie and Pharma drug development processes
• Must have demonstrated strong leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion across multiple complex projects
• Demonstrated leadership skills with broad scientific and business-related orientations
• Demonstrated project management skills such as scope management, progress tracking/driving as well as people and time management
• Key contributor to initiatives and advancement of Clinical Pharmacology