Director Clinical Pharmacology

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

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