Director, Clinical Pharmacology (Immunology)
About The Position
The Director, Clinical Pharmacology leads Clinical Pharmacology, PK/PD activities, and major drug development projects. The role communicates and presents clinical pharmacology information and strategy to senior and executive management, regulatory agencies, and external peers, and supports strategic planning to advance departmental goals and drug development objectives. It provides scientific interpretation of data and advises management on the implications of results, while serving as a liaison to other departments and divisions. The director provides strategic and scientific consultation across R&D, Regulatory, and management; assesses project risks, resolves issues, and helps develop contingency plans; and coordinates timelines, deliverables, and outcomes across functions. The role also evaluates technical and scientific aspects of AbbVie projects, reviews protocols and reports for regulatory filings, leads Clinical Pharmacology regulatory writing and submissions, and responds to agency comments. Additional responsibilities may include leading teams, managing personnel, mentoring, and delegating effectively. The position requires current knowledge of PK/PD data analysis, modeling, and simulation methods and software.
Requirements
- PhD with typically 7 or more years of relevant experience; or PharmD with typically 9 or more years; or MS or equivalent education with typically 15 or more years; or BS or equivalent education with typically 17 or more years.
- Relevant experience in 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.
- Participation in Clinical Pharmacology initiatives and advancement.
- Ability to understand cross-functional contributions needed to deliver results, persist through challenges, act respectfully and courageously, generate original ideas, influence cross-functional alignment, communicate openly and honestly, and manage conflict constructively and transparently.
Responsibilities
- 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, support issue resolution, conduct risk assessments, develop contingency plans, and keep projects aligned with strategic objectives.
- Provide overall timelines to assess portfolio opportunities and negotiate with other functional areas on project outcomes and deliverables amid competing 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 and anticipate regulatory questions.
- Lead Clinical Pharmacology regulatory document writing and submission, and respond to regulatory agency comments.
- Conduct due diligence assessments, summarize results, and represent Clinical Pharmacology on business development teams.
- Identify process improvement initiatives and review recommendations with management.
- Contribute to departmental goals and influence strategic PK/PD decisions.
- Perform responsibilities with regard for quality and timeliness, and maintain current knowledge of PK/PD data analysis, modeling, and simulation methods and software.
- Communicate and present Clinical Pharmacology information and strategy to senior and executive management, regulatory agencies, and external peers.
- Serve as a liaison to other departments and divisions for study and project needs.
- May lead teams within Clinical Pharmacology and Pharmacometrics and be accountable for their effective performance.
- May manage personnel, including development, mentoring, and effective delegation.
Benefits
- Paid time off, including vacation, holidays, and sick time.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in long-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Director
