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About the Role

This role communicates and presents key Clinical Pharmacology information and strategy to senior management, regulatory agencies, and external peers. It supports strategic planning for drug development activities and projects, utilizing scientific expertise to interpret data and its implications. The position may lead teams within Clinical Pharmacology and Pharmacometrics, ensuring effective 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 business objectives.
• Identifies issues and aids in their resolution.
• Conducts risk assessments and assists in developing contingency plans.
• Ensures projects remain aligned with strategic objectives.
• 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.
• Evaluates technical and scientific aspects of all AbbVie projects with CLINICAL PHARMACOLOGY management.
• Reviews clinical protocols and scientific reports for regulatory filings and anticipates regulatory questions.
• Leads CLINICAL PHARMACOLOGY regulatory documents 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.
• 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.

Requirements

• PhD with typically 7+ years of experience or Pharm D 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 as well as time management.
• Participates in initiatives and advancement of CLINICAL PHARMACOLOGY.

Skills

• PK
• PBPK
• PK-PD
• Pharmacometrics
• Systems pharmacology
• Drug metabolism
• Transporters
• Leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometric activities
• Scientific project leadership
• Project management
• Scope management
• Progress tracking/driving
• Time management

Location

• US & Puerto Rico

Work Type

• Full-time

Experience Level

• 7+ years (PhD)
• 9+ years (Pharm D)
• 15+ years (MS)
• 17+ years (BS)

Education Level

• PhD
• Pharm D
• MS
• BS

Salary/Compensations

• USD 160500 - USD 305000 - yearly

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Long-term incentive programs

About the Company

• AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
• We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio.
• For more information about AbbVie, please visit us at www.abbvie.com.
• Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Equal Opportunity

• AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.
• Equal Opportunity Employer/Veterans/Disabled.
• US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
• US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html