Clinical Pharmacologist

Mantell Associates is partnered with an innovative precision genetic medicine company, who is searching for a Clinical Pharmacologist to join the team on a 6 month contract.

Clinical Pharmacologist - Responsibilities:

• Bring the highest level of scientific thinking together with pragmatic design thinking to deliver candidate drugs and/or development plans, documentation, data interpretation and decisions for Clients’ compounds and products
• Lead the design, analysis, and interpretation of clinical pharmacology studies (renal, hepatic, TQT, ADME, DDI, BE/BA, SAD, MAD, etc.) and provide guidance to optimize pharmacokinetic sampling and dosing strategies
• Act as DMPK/Clinical Pharmacology project leader providing strategic advice and developing clinical pharmacology strategic plans
• Contribute to or conduct non-compartmental and compartmental pharmacokinetic analysis
• Contribute to or conduct PK/PD analysis and population PK modelling and simulation
• Prepare and review PK reports and other clinical pharmacology documents
• Collaborate with biometrics and stats programming on PK, PK/PD, and population PK analyses
• Author clinical protocols and clinical pharmacology and ADME sections of regulatory documents, including INDs, NDAs, briefing packets, Investigator Brochures, etc.
• Support client’s nonclinical efforts to ensure that sufficient preclinical PK data exists to design and execute clinical studies
• 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 practice

Clinical Pharmacologist - Requirements:

• Educated to PhD level and more than 5 years’ experience across DMPK, and Clinical Pharmacology Sciences
• Or Bachelors degree and more than 10 years’ experience across DMPK and Clinical Pharmacology Sciences
• Experience of drug development and evidence of ability to develop drug products that meet clinical and regulatory requirements and documentation
• Ability to apply scientifically sound principles efficiently in the analysis and interpretation of pharmacokinetic data is a necessity
• A publication and candidate drug / drug product delivery record that clearly demonstrates thought leadership in aspects of drug development
• Evidence of ability to influence and project leadership skills
• Evidence of scientific leadership and team capability development
• Ability to communicate well at all levels to both scientists and non-scientists
• Evidence of ability to meet deadlines and targets
• Self-motivated, able to operate independently

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.