Head of Drug Substance Strategy and Development
A pharmaceutical start up company in Haifa is looking for a Head of Drug Substance Strategy and Development, who is proactive, result-oriented and has team-building capabilities with credentialed scientific background and experience in leading manufacturing operations and drug product development.
Specifically – comprehensive experience in small proteins/peptides drug manufacturing in Escherichia coli expression system (CDMO project management).
· Translate strategy into operational plans.
· Coordinate with experts/KOLs to generate and execute a clear drug development plan in the fields of toxicology, PK, CMC development, and clinical trial design.
· Coordinate with regulatory consultants the preclinical regulatory strategy leading to clinical trials.
· Preparation of the non-clinical sections of regulatory documents for clinical trial application.
· Screen contract vendors to select partners for CMC development/manufacturing, toxicology assessments and PK characterization.
· Analyse budgets and study protocols and guide contract vendors to ensure all studies are conducted according to plans, timelines, budgets, and relevant guidelines.
· Work closely with the CEO to assess opportunities and challenges, as well as to implement strategic decisions on the ground.
A PhD in biotechnology (or similar) with experience in drug development, ideally related to diabetes and metabolic diseases. Expertise in drug development and manufacturing for clinical trials, managing all activities related to regulatory development and toxicology, PK, CMC and clinical trial support.