Clinical Development Manager

Job Description

Azurity Pharmaceuticals is seeking a Clinical Development Manager to join their Clinical Development team. This role is crucial for early development activities, supporting product evaluation and testing across various therapeutic areas. The Manager will report to the Director, Clinical Development, collaborating with stakeholders to ensure scientific excellence and effective relationships across R&D.

• Designing studies, considering technical, regulatory, and formulation aspects.
• Collaborating with program managers and study teams to develop study plans.
• Ensuring clinical study compliance with GCP and regulatory guidelines.
• Overseeing study operations, including initiation, monitoring, and closeout.
• Performing non-compartmental PK analysis and communicating trial status.
• Overseeing data repository, TMF, and critical study documents.
• Contributing to the development of clinical study documents.

• Master’s, Pharm.D, or PhD degree in clinical research, pharmacology, or pharmaceutics.
• Minimum of 6 years of pharmaceutical industry experience.
• 4-5 years of experience in Phase 1 (or 2) clinical development.
• Understanding of US and ex-US regulatory clinical requirements.
• Knowledge in ICH guidelines and GCP.
• Experience in research data analysis and publications.
• Strong organizational, interpersonal, and communication skills.

• Opportunity to contribute to innovative products.
• Work within a talented and dedicated team.
• Be part of an inclusive workplace.