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AbbVie

Global biopharmaceutical company developing medicines

Director – Clinical Pharmacology - Immunology

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours
Full-timeWaltham, MA, USAHybrid

About the Job

Requirements

  • A PhD with typically 7 or more years of experience in a relevant field; a PharmD with typically 9 or more years; an MS or equivalent education with typically 15 or more years; or a BS or equivalent education with typically 17 or more years. Relevant fields include experience with pharmacokinetics, physiologically based pharmacokinetics, pharmacokinetics/pharmacodynamics, pharmacometrics, systems pharmacology, drug metabolism, or 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 pharmaceutical drug development processes.
  • Demonstrated leadership competencies in pharmacokinetics/pharmacodynamics, biopharmaceutics, and pharmacometric activities from planning and implementation through completion across multiple projects.
  • Scientific project leadership or related experience.
  • Project management skills, including scope management, progress tracking and driving, and time management.
  • Participation in initiatives and advancement of Clinical Pharmacology.
  • Knowledge of pharmacokinetics/pharmacodynamics data analysis, modeling, and simulation methods and software.
  • Ability to know the business and cross-functional contributions needed to deliver results; persist and remain resilient in moving ideas forward; act respectfully and courageously; connect concepts and generate original ideas; influence colleagues to achieve cross-functional alignment; communicate openly and honestly; and manage conflict and difficult conversations constructively and transparently.

Responsibilities

  • Communicate and present key Clinical Pharmacology information and strategy to senior and executive management, regulatory agencies, and external peers.
  • Support strategic planning for drug development activities and projects to achieve departmental strategies, goals, and objectives.
  • Apply scientific expertise to interpret data and explain the implications of results to management.
  • Serve as liaison to other departments and divisions for study and project needs.
  • Understand linkages across businesses and the impact of business decisions and solutions.
  • Lead Clinical Pharmacology and Pharmacometrics teams as needed and be accountable for their effective performance.
  • Lead Clinical Pharmacology, pharmacokinetics/pharmacodynamics activities, and multiple major projects; assist R&D senior management in selecting action plans that best meet drug development business objectives.
  • Identify issues, help resolve them, conduct risk assessments, assist in developing contingency plans, and ensure projects remain aligned with strategic objectives.
  • Provide overall timelines to assess portfolio opportunities and negotiate with other functional areas on project outcomes and deliverables to address conflicting demands involving time, cost, and quality or performance.
  • Provide scientific and strategic consultation to R&D, Regulatory, and all levels of management on critical decisions and development plans.
  • Evaluate the technical and scientific aspects of AbbVie projects with Clinical Pharmacology management; review clinical protocols and scientific reports for regulatory filings and anticipate regulatory questions.
  • Lead Clinical Pharmacology regulatory document writing, submission, and responses to regulatory agency comments.
  • Conduct due diligence assessments independently, summarize results, and represent Clinical Pharmacology on business development teams.
  • Identify and develop process improvement initiatives and review recommendations with management for approval and sponsorship.
  • Contribute to departmental goals and influence strategic pharmacokinetics/pharmacodynamics decisions for the department.
  • Perform functions and responsibilities with regard for quality and timeliness and maintain up-to-date knowledge of pharmacokinetics/pharmacodynamics data analysis, modeling, and simulation methods and software.
  • Manage personnel as applicable, including their development, mentoring, and effective delegation.

About the Company

AbbVie

Global biopharmaceutical company developing medicines

AbbVie is a global biopharmaceutical company that develops and sells medicines to treat serious health conditions. Its portfolio spans immunology, oncology, virology, neuroscience, and aesthetics, with products designed to modulate the immune system, target disease pathways, or support medical aesthetics. AbbVie compounds its products through a heavy emphasis on research and development, investing billions to build a steady pipeline of new therapies. Its medicines are brought to market by selling to healthcare providers, hospitals, and clinics, and in some cases directly to patients via prescriptions. The company differentiates itself through a wide, globally distributed product line, substantial R&D investment, and a commitment to sustainability and patient care, including science-based targets. AbbVie’s goal is to improve patient outcomes by delivering effective treatments for unmet medical needs while pursuing long-term, responsible growth across healthcare markets.

Company size
10,001+
Company stage
IPO
Headquarters
North Chicago, IL
Founded
1888

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