Director Quantitative Pharmacologist

Role Summary

As a Director in Pharmacometrics (Quantitative Pharmacology), this individual is accountable for the delivery of support for one or more research & development programs within their pharmacometrics discipline. The Director is accountable for the timely and accurate delivery of quantitative analyses, interpretation, and messaging to PMx management, as well as the timely delivery of well-constructed and well-messaged reports for PMx review.

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 ‚Äústory-line‚Äù 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.
• Has a strong publication record and actively publishes work in scientific literature.
• Makes contributions to multi-disciplinary meetings by sharing cross-functional skills and knowledge.
• Has excellent interpersonal and communication skills, both written and oral, and ability to communicate complex information succinctly.

Qualifications

• Are fully knowledgeable of pharmacokinetic/pharmacodynamic principles, pharmacology, biology, and quantitative aspects of drug development, with advanced knowledge of pharmaceutical drug development.
• Possess a deep understanding of scientific literature and technical skills in PK/PD methods and techniques; extensive knowledge of work in the scientific community in the discipline.
• Recognized as an expert in their area within the organization.
• Have extensive regulatory experience through authoring regulatory briefing books, CTD summaries, contributions at HA meetings, and regulatory reviews/approvals of BLA or equivalent.
• Decisions are guided by policies, procedures and business plan; receives guidance from head of function.

Education

• PhD with 8+ years of experience in Quantitative Pharmacology (pharmacometrics) or related field.

Skills

• Hands-on usage of a broad range of quantitative tools and systems; strong publication record in the field.
• Excellent interpersonal and communication skills (written and oral); ability to communicate complex information succinctly.
• Proven experience developing QP elements of regulatory strategy and interacting with regulatory agencies without supervision.