Job Description
Communicates/presents key Clinical Pharmacology information/strategy to senior/executive management, regulatory agencies, and external peers. Supports strategic planning for drug development activities/projects. Interprets PK/PD data and relates implications to management. Acts as liaison across departments/divisions for study/project needs. May lead Clinical Pharmacology and Pharmacometrics teams.
Responsibilities
- Lead Clinical Pharmacology/PK/PD activities and multiple major projects; support selection of action plans aligned to drug development objectives.
- Identify issues; perform risk assessments; develop contingency plans; maintain alignment with strategic objectives.
- Provide portfolio timelines; negotiate deliverables/outcomes across functions balancing time, cost, and quality/performance.
- Provide scientific/strategic consultation to R&D, Regulatory, and management on critical decisions.
- Evaluate technical/scientific aspects of projects; review protocols/reports for regulatory filings; lead regulatory document writing, submissions, and responses to agency comments.
- Conduct due diligence assessments; represent Clinical Pharmacology on business development teams.
- Develop process improvements; contribute to departmental goals; influence strategic PK/PD decisions.
- Maintain up-to-date knowledge of PK/PD analysis, modeling, and simulation tools/methods; may manage/mentor personnel.
Qualifications
- PhD (7+ yrs) or PharmD (9+ yrs) in relevant field; MS (15+ yrs) or BS (17+ yrs). Relevant field includes PK, PBPK, PK-PD, pharmacometrics/systems pharmacology, drug metabolism/transporters.
- Excellent interpersonal skills; knowledge across multiple therapeutic/functional areas; experience across development phases.
- Demonstrated leadership in PK/PD, biopharmaceutics, and pharmacometrics across planning-to-completion.
- Scientific project leadership; project management (scope, progress/time tracking).
- Leadership competencies: cross-functional business acumen, resilience, respectful/courageous action, originality, alignment influence, open communication, constructive conflict management.
Benefits (if applicable/explicit)
- Paid time off; medical/dental/vision insurance; 401(k) to eligible employees; eligible for long-term incentive programs.