About this role

Provide input into product development strategies and/or research or clinical development plans
Author the clinical pharmacology plan for assigned products
Manage design and conduct of clinical pharmacology studies
Design clinical pharmacology study protocols and data analysis plans
Collaborate with cross-functional partners to monitor clinical pharmacology studies
Manage study timelines and resources
Conduct PK-PD and related analyses
Analyze and author documents for clinical and regulatory submissions
Represent clinical pharmacology for project teams in interactions with regulatory agencies

Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' Experience OR PhD/PharmD and Five Years' Experience
Excellent verbal, written, and interpersonal communication skills
Experience using pharmacokinetic program and analysis software (such as WinNonlin)
Experience leading small cross-functional project teams
Significant experience leading clinical pharmacology study concept and protocol design
Experience contributing to regulatory filings is strongly preferred
Thorough knowledge of FDA and EMA regulations, ICH guidelines, and GCP governing the conduct of clinical studies.
Ability to travel when needed

Associate Clinical Pharmacology Director

Key skills