Rigel is a clinical-stage biotechnology company dedicated to the discovery and development of novel, targeted drugs in the therapeutic areas of immunology, oncology and immuno-oncology. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms.
Our business strategy is to transition to a commercial-stage company with our Phase 3 results from fostamatinib in immune thrombocytopenic purpura (ITP). We continue to build an extensive portfolio of products in immunology and oncology, monetizing select assets through attractive partnerships. Rigel has submitted an NDA for fostamatinib. The Head of Preclinical Development & Clinical Pharmacology will manage a department team and work closely with the CMO and other key stakeholders advancing Rigel’s drug candidate pipeline.
The Head of Preclinical Development and Clinical Pharmacology is responsible for directing the bio-analysis, drug metabolism, pharmacokinetics, toxicology and clinical pharmacology support in regulatory filings (NDAs/INDs/CTXs) and development candidate nomination. He/she will lead a department team in advancing drug targets in Rigel’s pipeline. Rigel is filing an NDA and has several drug candidates in preclinical and clinical development. This position will report to the Chief Medical Officer.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Manage department team in performing bio-analysis, drug metabolism, pharmacokinetics, toxicology and clinical pharmacology work toward supporting drug discovery, preclinical development and clinical development projects, and in filing NDAs/INDs/CTXs
• Directing the overall operations, budgets and capital assets of the department
• Supervising personnel of Department
• Developing and maintaining professional liaison with all levels of the organization
KNOWLEDGE AND SKILL REQUIREMENTS:
• Demonstrated ability to lead teams and bring in projects on budget / deadline while maintaining study’s scientific integrity and adherence to FDA guidelines
• Research, preclinical, development and management experience in industry or contract research organization
• Proven skills in building teams, supervising personnel, and completing projects
• Expertise in bio-analysis, drug metabolism, pharmacokinetics, toxicology and clinical pharmacology
• PhD Degree, preferably in Pharmacology, Drug Metabolism, Toxicology or related discipline
• At least 12 years of industry experience in drug development and/or commercialization, clinical research experience preferred with a minimum of 8 years in management position
• Knowledge and industry experience in pharmacokinetics, drug metabolism, bio-analysis, toxicology and clinical pharmacology
• Experience in regulatory filings (NDAs/ INDs/CTXs) and development candidate nomination
• Working Knowledge of GLP, GCP and ICH
• Proficient computer skills