About
Clora's client is preparing to advance a novel, investigational, intravenously administered next-generation polymyxin antibiotic being developed to treat MDR Gram-negative bacterial infections, into a Phase 2 trial in participants with hospital-acquired or ventilator-associated bacterial pneumonia. This client expects to submit an investigational new drug (IND) application to the FDA to support this Phase 2 trial in the fourth quarter of 2023. This candidate will provide Regulatory leadership for this program and will need to fulfill the responsibilities previously defined.
Responsibilities
- Lead Regulatory strategy and execution for initial IND and global CTA submission and clinical studies for a Phase 2 program.
- Provide guidance as Regulatory representative on multi functional project teams and with Contract Research Organizations and other vendors as needed.
- Interact with Regulatory Authorities including managing initial submissions, response to information requests, and maintenance of application(s).
- Liaise with external funding partners
Ideal Candidate
Skills
Functional Areas
Regulatory Affairs
Therapeutic Areas
Infectious Disease
Product Technologies
Drug
Diseases/Indications
Gram-Negative Bacterial Infections
Development Phases
II/Proof of Concept
Regulatory Pathways
IND