Purpose
Communicates/presents key Clinical Pharmacology information/strategy to senior and executive management, regulatory agencies, and external peers. Leads strategic planning for drug development activities and projects. Utilizes scientific expertise to interpret data and relate implications to management. Serves as liaison to other departments/divisions for study/project needs. Influences and strategically manages linkages across businesses. Leads teams within Clinical Pharmacology and Pharmacometrics and is accountable for effective team performance.
Responsibilities
- Independently leads Clinical Pharmacology/PK/PD activities and multiple major projects; assists R&D senior management with action plan selection.
- Identifies issues impacting complex projects; leads issue resolution, risk assessments, and contingency planning to maintain alignment with strategic objectives.
- Provides overall timelines; negotiates project outcomes/deliverables with other functional areas to meet time, cost, and quality/performance demands.
- Provides expert scientific and strategic consultation to R&D, Regulatory, and management; connects scientific/regulatory/business implications; strategically manages cross-business linkages.
- Evaluates technical/scientific aspects of AbbVie projects with Clinical Pharmacology management; reviews clinical protocols and scientific reports for regulatory filings; leads regulatory document writing/submission and responses to agency comments.
- Conducts due diligence assessments; summarizes results; represents Clinical Pharmacology on business development teams.
- Identifies/develops process improvement initiatives and secures management approval/sponsorship.
- Leads departmental goals and makes strategic PK/PD decisions.
- Manages personnel (development, mentoring, delegation) and leads cross-functional teams; mediates disputes and facilitates high-performing teams.
Qualifications
- Hybrid; 3x/week in Lake County, IL.
- PhD (typically 9+ years) or PharmD (typically 11+ years) in a relevant field; or MS (typically 17+ years) or BS (typically 19+ years+); relevant field includes PK, PBPK, PK-PD, Pharmacometrics/systems pharmacology, drug metabolism/transporters.
- Excellent interpersonal skills.
- Advanced knowledge across multiple therapeutic and/or functional areas.
- Experience across a range of development phases.
- Recognized expert with global knowledge of AbbVie and pharma drug development processes.
- Demonstrated strong leadership in PK/PD, biopharmaceutics, and pharmacometrics from planning through completion on complex projects.
- Demonstrated leadership and project management skills (scope, progress tracking/driving, people/time management).
- Key leadership competencies: knows cross-functional business contributions; manages conflict constructively; develops direct reports through coaching/stretch assignments; provides transparent feedback; creates an inclusive environment.
Benefits
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees.