Director, Clinical Pharmacology

Role Summary

Director, Clinical Pharmacology responsible for communicating and presenting key Clinical Pharmacology information and strategy to senior management, regulatory agencies, and external peers. Supports strategic planning for drug development activities, provides scientific interpretation of data, and serves as a liaison across departments. May lead teams within Clinical Pharmacology and Pharmacometrics.

Responsibilities

• Leads Clinical Pharmacology/PK/PD activities and multiple major projects; assists R&D senior management in selecting action plans that meet drug development objectives.
• Identifies issues, conducts risk assessments, and develops contingency plans; ensures projects remain aligned with strategic objectives.
• Provides timelines to assess portfolio opportunities; negotiates with other functions on project outcomes and deliverables to balance time, cost, and quality.
• Provides scientific and strategic consultation to R&D, Regulatory, and management on decisions and development plans.
• Evaluates technical and scientific aspects of AbbVie projects; reviews clinical protocols and reports for regulatory filings; leads writing of regulatory documents and responses to regulatory questions.
• Independently conducts due diligence, summarizes results, and represents Clinical Pharmacology on business development teams.
• Identifies and develops process improvements; reviews recommendations with management for approval.
• Contributes to development of departmental goals and influences strategic PK/PD decisions.
• Maintains up-to-date knowledge of PK/PD data analysis, modeling, and simulation methods/software; ensures high quality and timely delivery.
• May manage personnel including development, mentoring, and delegation.

Qualifications

• PhD with typically 7+ years of experience or PharmD with typically 9+ years; MS/equivalent with typically 15+ years; BS/equivalent with typically 17+ years. Relevant fields include PK, PBPK, PK-PD, Pharmacometrics, systems pharmacology, or drug metabolism/Transporters.
• Excellent interpersonal skills; experience across multiple therapeutic/functional areas and development phases.
• Knowledge of AbbVie and pharma drug development processes.
• Demonstrated leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometrics across multiple projects.
• Scientific project leadership or related experience; strong project management skills (scope, progress tracking, time management).
• Active participation in initiatives for Clinical Pharmacology advancement.
• Key leadership competencies: business understanding, resilience, respectful and courageous leadership, ability to connect concepts, influence cross-functional alignment, open communication, and constructive conflict management.

Skills

• PK/PD modeling and simulation
• Clinical pharmacology regulatory writing and submissions
• Due diligence and business development collaboration
• Cross-functional collaboration and leadership
• Strategic planning and risk management

Education

• Doctoral degree (PhD) or PharmD with extensive experience in relevant pharmacology fields

Additional Requirements

• Hybrid onsite requirement: 3 days per week in Lake County.