As a Director in Pharmacometrics (Quantitative Pharmacology), this individual is is accountable for the delivery of support for one or more research & development programs, within their pharmacometrics discipline. In this capacity the Director is accountable for the timely and accurate delivery of needed quantitative analyses, interpretation, and messaging to PMx management, as well as the timely delivery of well-constructed and well-messaged reports for PMx review.
A day in the life of a Director may look like:
·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.
·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 has ability to communicate complex information succinctly.
This may be the right role for you if you:
· Are fully knowledgeable of pharmacokinetic /pharmacodynamic principles, pharmacology, biology, and quantitative aspects of drug development as well as having an advanced knowledge of pharmaceutical drug development.
·Possess a deep understanding of scientific literature and technical skills in a number of PK/PD methods and techniques. Has extensive knowledge base of the work in overall scientific community in own discipline.
· Recognized as an expert in own area within the organization.
·Have 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.
·Decisions are guided by policies, procedures and business plan; receives guidance from head of function.
In order to be considered qualified for this role, you must have a 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, as is a strong publication record in the field.
A proven track record of displaying excellent interpersonal and communication skills both written and oral and ability to communicate complex information succinctly.
Proven experience developing QP elements of regulatory strategy and interacting with regulatory agencies without supervision.
