Director, Clinical Pharmacology (Oncology)

Role Summary

Director, Clinical Pharmacology (Oncology) – Lead Clinical Pharmacology/PK/PD activities and provide scientific and strategic guidance across drug development programs; may lead teams and coordinate with R&D, Regulatory, and business partners to meet objectives.

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 to keep projects aligned with strategic goals.
• 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 projects; reviews protocols and reports for regulatory filings; leads writing, submission, and responses to regulatory comments.
• Independently conducts due diligence assessments and represents Clinical Pharmacology on business development teams.
• Identifies/processes improvements and presents recommendations for approval and sponsorship.
• Contributes to departmental goals and influences strategic PK/PD decisions.
• Maintains up-to-date knowledge of PK/PD analysis, modeling, and simulation methods/software.
• May manage personnel including development, mentoring, and delegation.

Qualifications

• PhD with typically 7+ years of experience or PharmD with typically 9+ years of experience in a relevant field; MS or equivalent with typically 15+ years; BS with typically 17+ years. Relevant fields include PK, PBPK, PK-PD, Pharmacometrics or systems pharmacology, drug metabolism/transporters.
• Excellent interpersonal skills; knowledge/experience across multiple therapeutic/functional areas.
• Experience across a range of development phases; knowledge of AbbVie and pharma drug development processes.
• Demonstrated leadership in PK/PD, Biopharmaceutics, and Pharmacometrics across multiple projects; scientific project leadership or related experience.
• Project management skills (scope, progress tracking, time management).
• Participation in initiatives and advancement of Clinical Pharmacology; strong cross-functional collaboration and communication.

Skills

• Scientific expertise in PK/PD, modeling and simulation; ability to interpret data and relate results to management decisions.
• Strong strategic and stakeholder management capabilities; effective negotiation and conflict resolution.

Education

• Doctoral-level degree (PhD) or PharmD (with substantial experience), or MS/BS with extensive equivalent experience in a relevant field.