Job Title Vice President, Clinical Pharmacology
CATO SMS is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them.
CATO SMS is a non-laboratory environment.
We are currently recruiting for a Vice President, Clinical Pharmacology consultant to join our team remotely.
Specific responsibilities of this position include but are not limited to :
Provide strategic advice to clients on clinical pharmacology trials (e.g., clinical trial design, etc.) and overall early phase drug development activities.
Work with pharmacokineticists to finalize PK / PD deliverables for clients.
Develop statistical and PK analysis plans and produce standalone PK / PD reports that can be appended to clinical study reports.
Provide overall regulatory and drug development expertise to clients.
Conduct PK / PD and population PK / PD (modeling and simulation) projects
Lead clinical pharmacology contributions by preparing and reviewing clinical protocols, clinical study reports, clinical pharmacology strategic plans, INDs, clinical pharmacology and safety sections of NDAs, Investigator Brochures, FDA briefing packets, and other clinical and regulatory documents.
Contribute to clinical pharmacology studies from a strategic perspective to assist clients on designing and executing early phase human trials.
Represent the company as a PK / PD expert
Work cross-functionally with pharmacometricians to provide strategies to clients on study design and planning.
Maintain up-to-date training on cGLP regulations, appropriate company SOP's and internal CATO SMS guidances.
Typically requires 10+ years of experience.
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