Director, Clinical Pharmacology (Oncology)

Role Summary

Director, Clinical Pharmacology (Oncology) responsible for communicating and shaping Clinical Pharmacology strategy to senior management, regulatory agencies, and external peers; leading PK/PD activities; and guiding drug development programs within AbbVie’s oncology portfolio.

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 assists in contingency planning to keep projects aligned with strategic objectives.
• Provides overall timelines to assess portfolio opportunities and negotiates with other functions to meet time, cost, and quality demands.
• 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 regulatory documents writing and responses to agency comments.
• Independently conducts due diligence assessments and represents Clinical Pharmacology on business development teams.
• Identifies and develops process improvement initiatives; seeks management approval and sponsorship.
• Contributes to departmental goals and influences PK/PD decisions for the department.
• Maintains up-to-date knowledge of PK/PD data analysis, modeling, and simulation methods/software; ensures quality and timeliness in all responsibilities.
• 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 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/functional areas and development phases.
• Knowledge of AbbVie and pharmaceutical drug development processes.
• Demonstrated leadership competencies in PK/PD, biopharmaceutics, and pharmacometrics across multiple projects.
• Scientific project leadership or related experience; strong project management, scope management, and time management skills.
• Active participation in advancing Clinical Pharmacology initiatives.
• Key Leadership Competencies: business understanding across functions, resilience, respectful and courageous conduct, ability to connect concepts and generate ideas, influence for cross-functional alignment, open communication, and constructive conflict management.

Skills

• Strategic and scientific thinking; ability to provide timely, data-driven decisions.
• Proficiency in PK/PD data analysis, modeling, and simulation methods and software.
• Communication and collaboration across R&D, Regulatory, and management levels.

Education

• PhD or PharmD with extensive experience; or MS with substantial industry experience in related fields.

Additional Requirements

• This is a hybrid onsite role requiring 3 days per week onsite.