Sr Director Clinical Pharmacology
New Today
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
- Location:
- Madison