Sr Director Clinical Pharmacology - Barrington James : Job Details

Sr Clinical Pharmacology Director Location: East Coast - Remote Background: The company is currently planning 3 Phase 1 studies (SAD/MAD) for small molecules developed for psychiatric conditions The studies will be conducted in Europe and in US Responsibilities Understand the drug' Pharmacokinetic and Pharmacological properties and its implications on clinical development. Define the targeted PK profile Lead clinical pharmacology development to support drug development, from early stage towards NDA/MA submission Develop Phase 1 strategy, incl study design, synopsis/protocol Manage Operational aspects of the Phase 1 study/ies, incl. CRO selection, budget, interface and oversight of CRO Manage ClinPharm related regulatory activities PK modeling Biomarker strategy Requirements PhD/MSc in pharmaceutical/life sciences, PharmD or any other relevant education 5+ years' experience in clinical pharmacology Experience in designing, setting up, and conducting phase 1 studies including managing CROs and any external service providers Understanding of regulatory requirements (FDA/EMA) for Ph1/Clin Pharm studies Ability to work in a multi-disciplinary environment, globally High motivation and proactive approach Good oral and written communication and presentation skills Advantages Experience with CNS drug development, and specifically in NMDA antagonist MOA and muscarinic agonist MOA Experience in Abuse Liability aspects Experience with translational medicine in CNS #LI-OG1