- Location
- Remote · Redwood City
- Workplace
- Remote
- Type
- Full-time
- Department
- Clinical Development
- Seniority
- Senior
- Education
- PhD
- Source
- Lever
Description
Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.
Rezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders
More information can be found at rezolutebio.com
The Director / Senior Director, Pharmacovigilance Operations will play a critical leadership role in building and executing the company’s pharmacovigilance and drug safety capabilities as the organization advances its lead product toward regulatory approval and commercial launch.
This individual will be responsible for ensuring an effective, scalable, and inspection-ready pharmacovigilance system supporting late-stage clinical development, regulatory submissions, product launch, and post-marketing safety surveillance. The role will provide leadership across safety operations, benefit-risk management, signal detection and management, aggregate reporting, safety governance, vendor oversight, and global regulatory compliance.
As the company evolves from a development-stage organization to a commercial biopharmaceutical company, the Director/Senior Director will help establish the people, processes, systems, governance, and external partnerships required for commercial pharmacovigilance.
The successful candidate will combine strong scientific and medical judgment with practical operational experience implementing pharmacovigilance capabilities in a growing organization.