As a Director in Pharmacometrics (PPK / PD, QP, or CP as appropriate), this individual is is accountable for the delivery of support for one or more research & development programs, within their pharmacometric 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 typical day in the role might 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.
This role might be for you if :
Is 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.
Possesses 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.
Has 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.
Director Quantitative Pharmacology
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 ...
Senior Director, Quantitative Pharmacology
As a Senior Director in Pharmacometrics (PPK/PD, QP, or CP as appropriate), this individual will be responsible for managing PMx support for a number of programs in one or more therapeutic focus areas of the development portfolio. In this capacity the Senior Director is accountable for the successfu...
Senior Director, Quantitative Pharmacology
As a Senior Director in Pharmacometrics (PPK/PD, QP, or CP as appropriate), this individual will be responsible for managing PMx support for a number of programs in one or more therapeutic focus areas of the development portfolio. In this capacity the Senior Director is accountable for the successfu...
Director Quantitative Pharmacology
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. Is fully knowledgeable of pharmacokinetic /...
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