Director Quantitative Pharmacology

Director Quantitative Pharmacology

Requirements

• PhD +8 years with a degree in Quantitative Pharmacology (pharmacometrics) or related field
• Hands on usage of a broad range of quantitative tools and systems is required
• Strong publication record in the field
• Excellent interpersonal and communication skills, both written and oral
• Ability to communicate complex information succinctly
• Proven experience developing QP elements of regulatory strategy and interacting with regulatory agencies without supervision

Responsibilities

• Manages and is accountable for the PK/PD evaluation of a small portfolio of products or projects
• Works independently, with guidance in only the most complex situations
• Informs PMx management of important program and regulatory developments in a timely manner
• Ensures analyses and documentation are of the highest quality and accuracy
• Ensures that reports and other documents have the appropriate messaging and that a meaningful ‘story-line’ is developed
• Ensures that study reports and other documents have an appropriate functional review and are suitable for review by senior management
• Solves complex problems; takes a broad perspective to identify solutions
• Makes contributions to multi-disciplinary meetings by sharing cross-functional skills and knowledge

Preferred Qualifications

• Fully knowledgeable of pharmacokinetic/pharmacodynamic principles, pharmacology, biology, and quantitative aspects of drug development
• Deep understanding of scientific literature and technical skills in a number of PK/PD methods and techniques
• Extensive knowledge base of the work in overall scientific community in own discipline
• Recognized as an expert in own area within the organization
• Extensive regulatory experience through authoring of regulatory briefing books, CTD summaries, contribution at HA meetings, HA negotiations through regulatory reviews and approvals of BLA or equivalent