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AbbVie

Global biopharmaceutical company developing medicines

Director – Clinical Pharmacology - Immunology

Quantitative Biology & BiostatisticsConfirmed live in the last 24 hours
Full-timeSouth San Francisco, CA, USAHybrid

About the Job

Requirements

  • A PhD with typically 7 or more years of experience, 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 in a relevant field, including PK, PBPK, PK-PD, 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 PK/PD, 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.
  • Knowledge of PK/PD data analysis, modeling and simulation methods and software.
  • Ability to know the business and cross-functional contributions needed to deliver results; persistently and resiliently move good ideas forward; act respectfully and courageously; connect unrelated concepts and generate original or unique 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.
  • Use scientific expertise to interpret data appropriately and explain the implications of results to management.
  • Serve as a liaison to other departments and divisions for study and project needs.
  • Understand linkages across businesses and the impact of business decisions and solutions.
  • Lead teams within Clinical Pharmacology and Pharmacometrics as needed and be accountable for their effective performance.
  • Lead Clinical Pharmacology/PK/PD 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, develop 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 meet competing time, cost, and quality/performance demands.
  • 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; anticipate regulatory questions; and lead Clinical Pharmacology regulatory document writing, submission, and responses to 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 development of departmental goals and influence strategic PK/PD decisions for the department.
  • Perform functions and responsibilities with regard for quality and timeliness, and maintain up-to-date knowledge of PK/PD data analysis, modeling, and simulation methods and software.
  • Manage personnel as needed, including their development, mentoring, and effective delegation.
  • Participate in initiatives and advancement of Clinical Pharmacology.

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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