Medical Director, Clinical Research and Development

At ICON, it's our People that set us Apart"

Are you interested in contributing your Medical knowledge of Clinical Trials and contributing to our culture of process improvement with a focus on streamlining our processes- along with adding value to our business and meeting our client needs?

Medical Director Clinical Research and Development Phase 1:

Provide early phase clinical program and project expertise and leadership. Develop clinical study protocols, review and interpret clinical study data; develop clinical study reports and other applicable documents; serve as Medical Monitor, ensure the accuracy and quality of sponsor deliverables, and of all relevant CRD and IDS activities, and compliance with ethical, legal, scientific, regulatory and client standards.

The successful candidate will have Early Phase Experience, this is a must. Show capability in the areas of Clinical Trial operations, meeting regulatory and ICON guidelines while displaying strong sponsor communication skills and experience. A minimum of 4 years of similar relevant experience in clinical pharmacology, early clinical drug development (phase 1-2a), clinical research, regulatory science and preparing applicable clinical research documentation, with a substantial amount of that experience being in healthy volunteer (clinical pharmacology) studies such as: First-in-Human (FIH), Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Pharmacokinetic (PK), Pharmacokinetic-pharmacodynamics (PK-PD), Bioavailability/Bioequivalence (BA/BE), bio similar, Food Effect (FE), Drug-Drug Interaction (DDI), Thorough QT (TQT), renal impairment and hepatic impairment, as well as proof-of-concept (POC) and patient studies. Most of this experience should be in small molecules, with additional experience in biologics/vaccines/devises a plus. Prefer this experience in a CRO environment and/or Pharmaceutical Company. Must be a Medical Doctor with an active License in the US. Position can be home based.

ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.*LI-ZS1