Director, Clinical Pharmacology

Role Summary

Director, Clinical Pharmacology. 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 goals. May lead teams within Clinical Pharmacology and Pharmacometrics and is accountable for their performance.

Responsibilities

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

Qualifications

• PhD with typically 7+ years of experience or PharmD with typically 9+ years of experience; MS or equivalent with typically 15+ years; BS or equivalent with typically 17+ years. Relevant fields include PK, PBPK, PK-PD, Pharmacometrics, systems pharmacology, or drug metabolism/transporters.
• Excellent interpersonal skills.
• Knowledge and experience across 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 pharmacometrics across multiple projects.
• Scientific project leadership or related experience; strong project management skills (scope, progress tracking, time management).
• Ability to participate in initiatives advancing Clinical Pharmacology.
• Key leadership competencies: business awareness, persistence, respectful courage, idea generation, cross-functional influence, open communication, and constructive handling of conflict.

Skills

• PK/PD modeling and simulation
• Clinical pharmacology regulatory strategy
• Team leadership and delegation
• Strategic planning and risk management
• Cross-functional collaboration
• Regulatory submission preparation and responses

Education

• PhD or PharmD with extensive experience as described; advanced degree in pharmacology, pharmacometrics, or related field.

Additional Requirements

• Hybrid role requiring onsite presence 3x/week in South San Francisco.