Director

• Serves as a key member of the CP&P leadership team.
• Responsible and accountable for assigned clinical pharmacology strategy within assigned projects.
• Contributes to integrated strategy with Research, Drug Development, and Commercialization.
• Develops and executes clinical PK, PK/PD, pharmacometric analyses, and modeling & simulation (MS) plans.
• Drives decision-making and strategy over the entire portfolio through effective partnership with partner functions and senior leaders.
• Oversees scientific output, conduct and resourcing of clinical pharmacology, PK/PD, working in concert with pharmacometrics and QSP functional partners.
• Supports strategy for dose selection, dose justification and regulatory filings.
• Reviews and approves relevant scientific data and reports for regulatory filings.
• Develops technical/leadership skills of clinical and MS scientists.
• Participates in, or assigns qualified delegates to support in-licensing and out-licensing business development activities.
• Represents Clinical Pharmacology on relevant governance committees and works streams.
• Oversees planning, execution of clinical pharmacology trials in concert with clinical operations.
• Represents the ClinPharm department on cross-functional disease strategy teams and on relevant governance forums.
• Provides input to Phase 2/3 clinical study design and registrational strategy.
• Supervises the development of the Clinical Pharmacology Plan(s).
• Supervises design of Clinical Pharmacology studies and manages data analysis, interpretation, and reporting.
• Collaborates on cross-functional drug development teams, regulatory submissions, and departmental initiatives; serves as Clinical Pharmacology subject matter expert.
• Builds a team that is collaborative, supportive learning environment.

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