Director, Clinical Pharmacology
AbbVie
4 days ago
Remote friendly (South San Francisco, CA)
United States
$160,500 - $305,000 USD yearly
Clinical Research and Development
Responsibilities:
- Communicate/present Clinical Pharmacology information and strategy to senior/executive management, regulatory agencies, and external peers.
- Support strategic planning for drug development activities to meet departmental goals.
- Interpret data using scientific expertise and communicate implications to management.
- Serve as liaison across departments/divisions for study/project needs; understand business linkages and impacts.
- Lead Clinical Pharmacology/PK/PD activities and multiple major projects; assist R&D senior management with action plans.
- Identify issues, conduct risk assessments, develop contingency plans, and keep projects aligned with strategic objectives.
- Provide scientific/strategic consultation to R&D and Regulatory on critical decisions and development plans.
- Evaluate technical/scientific aspects of projects; review protocols/reports for regulatory filings; lead Clinical Pharmacology regulatory document writing/submission and responses.
- Independently perform due diligence and represent Clinical Pharmacology on business development teams.
- Identify/develop process improvements; contribute to departmental goals and influence strategic PK/PD decisions.
- Maintain up-to-date knowledge of PK/PD analysis, modeling, and simulation methods/software; may manage personnel.
Qualifications:
- PhD (7+ years) or PharmD (9+ years) in a relevant field; or MS (15+ years) or BS (17+ years), including experience with PK, PBPK, PK-PD, Pharmacometrics/systems pharmacology, and drug metabolism/transporters.
- Excellent interpersonal skills; knowledge/experience across therapeutic/functional areas and development phases.
- Knowledge of AbbVie/pharma drug development processes.
- Demonstrated leadership in PK/PD, biopharmaceutics, and pharmacometrics (planning through completion across multiple projects).
- Scientific project leadership; project management (scope, progress/time management).
- Key leadership competencies: cross-functional business understanding, persistence, respectful/courageous action, original thinking, alignment, open communication, constructive conflict management.
- Communicate/present Clinical Pharmacology information and strategy to senior/executive management, regulatory agencies, and external peers.
- Support strategic planning for drug development activities to meet departmental goals.
- Interpret data using scientific expertise and communicate implications to management.
- Serve as liaison across departments/divisions for study/project needs; understand business linkages and impacts.
- Lead Clinical Pharmacology/PK/PD activities and multiple major projects; assist R&D senior management with action plans.
- Identify issues, conduct risk assessments, develop contingency plans, and keep projects aligned with strategic objectives.
- Provide scientific/strategic consultation to R&D and Regulatory on critical decisions and development plans.
- Evaluate technical/scientific aspects of projects; review protocols/reports for regulatory filings; lead Clinical Pharmacology regulatory document writing/submission and responses.
- Independently perform due diligence and represent Clinical Pharmacology on business development teams.
- Identify/develop process improvements; contribute to departmental goals and influence strategic PK/PD decisions.
- Maintain up-to-date knowledge of PK/PD analysis, modeling, and simulation methods/software; may manage personnel.
Qualifications:
- PhD (7+ years) or PharmD (9+ years) in a relevant field; or MS (15+ years) or BS (17+ years), including experience with PK, PBPK, PK-PD, Pharmacometrics/systems pharmacology, and drug metabolism/transporters.
- Excellent interpersonal skills; knowledge/experience across therapeutic/functional areas and development phases.
- Knowledge of AbbVie/pharma drug development processes.
- Demonstrated leadership in PK/PD, biopharmaceutics, and pharmacometrics (planning through completion across multiple projects).
- Scientific project leadership; project management (scope, progress/time management).
- Key leadership competencies: cross-functional business understanding, persistence, respectful/courageous action, original thinking, alignment, open communication, constructive conflict management.