Director, Clinical Pharmacology
AbbVie
4 hours ago
Remote friendly (North Chicago, IL)
United States
$177,000 - $336,000 USD yearly
Clinical Research and Development
Purpose
- Communicate/present key Clinical Pharmacology information/strategy to senior/executive management, regulatory agencies, and external peers.
- Lead strategic planning for drug development activities/projects to achieve departmental strategies, goals, and objectives.
- Use scientific expertise to interpret data and relate implications to management.
- Serve as liaison to other departments/divisions for study/project needs.
- Influence and manage linkages across businesses and understand impacts of business decisions.
- Lead teams within Clinical Pharmacology and Pharmacometrics; accountable for team performance.
Responsibilities
- Independently lead Clinical Pharmacology/PK/PD activities and multiple major projects; assist R&D senior management with action plan selection.
- Identify issues across complex projects; lead issue resolution; conduct risk assessments and develop contingency plans.
- Provide overall portfolio timelines; negotiate outcomes/deliverables with functional areas to balance time/cost/quality.
- Provide expert scientific and strategic consultation to R&D and Regulatory; lead critical regulatory decision support.
- Review clinical protocols/scientific reports for regulatory filings; lead Clinical Pharmacology regulatory document writing/submission and agency comment responses.
- Conduct due diligence assessments; summarize results; represent Clinical Pharmacology on business development teams.
- Identify/develop process improvement initiatives; review recommendations for management sponsorship.
- Lead departmental goal-setting; make strategic PK/PD decisions.
- Manage personnel (development, mentoring, delegation) and lead cross-functional teams; mediate disputes and build high-performing teams.
Qualifications
- Hybrid (3x/week) in Lake County, IL.
- PhD (9+ years) or PharmD (11+ years); or MS (17+ years) or BS (19+ years). Relevant experience: PK, PBPK, PK-PD, Pharmacometrics/systems pharmacology, drug metabolism/transporters.
- Excellent interpersonal skills.
- Advanced knowledge across multiple therapeutic/functional areas.
- Experience across the range of development phases.
- Recognized expert with global knowledge of AbbVie and pharma drug development processes.
- Demonstrated leadership in PK/PD, biopharmaceutics, and pharmacometrics across complex projects.
- Demonstrated project management (scope, progress tracking/driving, people/time management).
- Key leadership competencies: cross-functional business understanding, constructive conflict management, coaching/stretch development, transparent timely feedback, inclusive environment.
Benefits
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible for short-term and long-term incentive programs.
- Communicate/present key Clinical Pharmacology information/strategy to senior/executive management, regulatory agencies, and external peers.
- Lead strategic planning for drug development activities/projects to achieve departmental strategies, goals, and objectives.
- Use scientific expertise to interpret data and relate implications to management.
- Serve as liaison to other departments/divisions for study/project needs.
- Influence and manage linkages across businesses and understand impacts of business decisions.
- Lead teams within Clinical Pharmacology and Pharmacometrics; accountable for team performance.
Responsibilities
- Independently lead Clinical Pharmacology/PK/PD activities and multiple major projects; assist R&D senior management with action plan selection.
- Identify issues across complex projects; lead issue resolution; conduct risk assessments and develop contingency plans.
- Provide overall portfolio timelines; negotiate outcomes/deliverables with functional areas to balance time/cost/quality.
- Provide expert scientific and strategic consultation to R&D and Regulatory; lead critical regulatory decision support.
- Review clinical protocols/scientific reports for regulatory filings; lead Clinical Pharmacology regulatory document writing/submission and agency comment responses.
- Conduct due diligence assessments; summarize results; represent Clinical Pharmacology on business development teams.
- Identify/develop process improvement initiatives; review recommendations for management sponsorship.
- Lead departmental goal-setting; make strategic PK/PD decisions.
- Manage personnel (development, mentoring, delegation) and lead cross-functional teams; mediate disputes and build high-performing teams.
Qualifications
- Hybrid (3x/week) in Lake County, IL.
- PhD (9+ years) or PharmD (11+ years); or MS (17+ years) or BS (19+ years). Relevant experience: PK, PBPK, PK-PD, Pharmacometrics/systems pharmacology, drug metabolism/transporters.
- Excellent interpersonal skills.
- Advanced knowledge across multiple therapeutic/functional areas.
- Experience across the range of development phases.
- Recognized expert with global knowledge of AbbVie and pharma drug development processes.
- Demonstrated leadership in PK/PD, biopharmaceutics, and pharmacometrics across complex projects.
- Demonstrated project management (scope, progress tracking/driving, people/time management).
- Key leadership competencies: cross-functional business understanding, constructive conflict management, coaching/stretch development, transparent timely feedback, inclusive environment.
Benefits
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.
- Eligible for short-term and long-term incentive programs.