Director, Clinical Pharmacology
Allucent, Netherlands
Job Description
CATO SMS is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. CATO SMS is a non-laboratory environment.
We are currently recruiting for Director, Clinical Pharmacology to join our team in the Amsterdam, Schiphol location with the option to work remotely. The successful candidate will possess a significant understanding of clinical PK and PK/PD concepts and applications as well as have knowledge of drug metabolism, physiology, and human and animal studies for drug development programs.
Responsibilities:
• Design, analyze, and interpret clinical pharmacology Phase 1 studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and clinical pharmacology data from late Phase 2 and Phase 3 studies using modeling and simulation techniques
• Critically evaluate technical and scientific aspects of Clinical PK/PD projects/programs for clients
• Provide strategic advice to clients, develop clinical pharmacology development plans, and take ownership/responsibility for client deliverables
• Contribute to and/or conduct non-compartmental and compartmental pharmacokinetic analysis, PK/PD analysis, and population PK modeling and simulation using industry standard software tools
• Contribute to and/or conduct Model Based Drug Development activities for clients including simulations to assist with dose justification and selection
• Author clinical protocols and clinical pharmacology and pharmacokinetic sections of regulatory documents, including INDs, NDAs, briefing packets, Investigator Brochures, etc.
• Represent clients at meetings with US and ex-US regulatory agencies
• Work with other consultants to prepare and review PK reports and other clinical pharmacology documents
• Support client’s nonclinical efforts to ensure that sufficient preclinical PK data exists to design and execute clinical studies
• Participate in multiple projects across diverse therapeutic areas
• Maintain current knowledge of advancements in PK and PK/PD science, regulatory guidance documents, FDA rulings, internal SOPs, and internal working practices to be able to contribute ideas to improve technologies and procedures for PK practices
• Support business development and marketing activities, foster client relationships, and bring new clients into the consulting firm.
Requirements
- An advanced degree and 5 to 10+ years of experience working with clinical pharmacology and pharmacokinetic studies is required
- Excellent writing skills and proficiency with industry standard tools for data analysis
- Comfort working directly with C-level executives at biopharmaceutical companies is also important
- Experience in working with small, emerging pharmaceutical and biotech companies and both with small molecules and biologics is a plus.
- Other combinations of appropriate experience and education will also be considered.