Director, Clinical Pharmacology (Immunology)
About The Position
The Director, Clinical Pharmacology (Immunology) leads Clinical Pharmacology, PK/PD activities, and multiple major projects. The role provides scientific and strategic consultation to R&D, Regulatory, and all levels of management, supporting drug-development planning and critical development decisions. It communicates Clinical Pharmacology strategy and information to senior and executive management, regulatory agencies, and external peers, and interprets data to explain its implications to management. The position evaluates the technical and scientific aspects of AbbVie projects, reviews clinical protocols and scientific reports for regulatory filings, anticipates regulatory questions, and leads the writing and submission of Clinical Pharmacology regulatory documents and responses to agency comments. It also represents Clinical Pharmacology on business development teams, conducts due diligence assessments, contributes to departmental goals, influences strategic PK/PD decisions, and identifies process improvements. The role may lead teams and manage personnel, including their development, mentoring, and delegation. The successful candidate maintains current knowledge of PK/PD data analysis, modeling and simulation methods, and software, and performs responsibilities with a strong regard for quality and timeliness. The role requires substantial relevant experience, scientific project leadership, project management skills, and demonstrated leadership across PK/PD, Biopharmaceutics, and Pharmacometric activities.
Requirements
- PhD with typically 7 or more years of relevant experience; PharmD with typically 9 or more years; 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, or 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 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 initiatives and advancement of Clinical Pharmacology.
Responsibilities
- Lead Clinical Pharmacology/PK/PD activities and multiple major projects, and assist R&D senior management in selecting action plans that meet drug-development business objectives.
- Identify issues, support their resolution, conduct risk assessments, develop contingency plans, and ensure projects remain aligned with strategic objectives.
- Provide overall timelines to assess portfolio opportunities and negotiate project outcomes and deliverables with other functional areas to address 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 and anticipate regulatory questions.
- Lead the writing and submission of Clinical Pharmacology regulatory documents and responses 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 for approval and sponsorship.
- Contribute to departmental goals and influence strategic PK/PD decisions for the department.
- Maintain up-to-date knowledge of PK/PD data analysis, modeling and simulation methods, and software.
- Potentially lead Clinical Pharmacology and Pharmacometrics teams and manage personnel, including development, mentoring, and effective delegation.
- 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.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- 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
