Director, Clinical Pharmacology & Pharmacometrics
仕事内容
Lead the development and execution of clinical pharmacology strategies across multiple programs from candidate nomination to Phase 4.
Drive PK/PD data analysis, interpretation, and study reporting to support internal decisions and regulatory submissions.
Serve as the clinical pharmacology lead within cross-functional teams, owning dose selection rationale in Phase 1 and contributing to later-stage dose decisions.
Partner with pharmacometrics and cross-functional teams to plan and support PKPD modeling for internal and regulatory decisions.
Prepare relevant sections of regulatory documents (IND, NDA/BLA) and address agency questions during reviews.
Manage consultants and vendors, and contribute to timely publication or presentation of clinical pharmacology and pharmacometrics data.
Drive PK/PD data analysis, interpretation, and study reporting to support internal decisions and regulatory submissions.
Serve as the clinical pharmacology lead within cross-functional teams, owning dose selection rationale in Phase 1 and contributing to later-stage dose decisions.
Partner with pharmacometrics and cross-functional teams to plan and support PKPD modeling for internal and regulatory decisions.
Prepare relevant sections of regulatory documents (IND, NDA/BLA) and address agency questions during reviews.
Manage consultants and vendors, and contribute to timely publication or presentation of clinical pharmacology and pharmacometrics data.
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