Director, Clinical Pharmacology (Immunology)

About the role

Communicates and presents key Clinical Pharmacology information and strategy to senior and executive management, regulatory agencies, and external peers. Supports 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 a liaison to other departments/divisions for any study or project needs. Understands linkages across businesses and the impact of business decisions and solutions. May lead teams within Clinical Pharmacology and Pharmacometrics and is accountable for effective performance of the teams.

Responsibilities

• Leads Clinical Pharmacology/PK/PD activities and multiple major projects.
• Assists R&D senior management in the selection of action plans that best meet drug development business objectives.
• Identifies issues and helps with issue resolution; conducts risk assessments and assists in development of contingency plans.
• Assures projects remain in alignment with strategic objectives and 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 scientific and strategic consultation to R&D, Regulatory, and all levels of management on critical decisions and development plans.
• Responsible for evaluating technical and 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 document 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.
• Contributes to the development of departmental goals and influences strategic PK/PD decisions for the department.
• Performs functions and responsibilities with the highest regard for quality and timeliness.
• Maintains up-to-date knowledge of PK/PD data analysis, modeling and simulation methods and software.
• May manage personnel including development, mentoring, and effective delegation.

Qualifications

• PhD with typically 7+ years of experience or PharmD with typically 9+ years of experience in a relevant field.
• MS or equivalent education with typically 15+ years of experience; BS or equivalent education and typically 17+ years of experience.
• Relevant field includes experience with PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, Drug metabolism/Transporters.
• Excellent interpersonal skills.
• Knowledge and experience in multiple therapeutic and/or functional areas.
• Experience across a range of development phases.
• Knowledge of AbbVie and Pharma drug development processes.
• Demonstrated leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion across multiple projects.
• Scientific project leadership or related experience.
• Project management skills such as scope management, progress tracking/driving, and time management.
• Participates in initiatives and advancement of Clinical Pharmacology.
• Key Leadership Competencies:
  • Knows the business and the cross-functional contributions needed to deliver results.
  • Persistent and resilient; finds the way to move good ideas forward.
  • Acts respectfully yet courageously.
  • Connects unrelated concepts; generates original or unique ideas.
  • Influences colleagues to achieve cross-functional alignment.
  • Communicates openly and honestly with all colleagues.
  • Manages conflict and difficult conversations in a constructive, transparent way.