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 P - Mx management, as well as the timely delivery of well-constructed and well-messaged reports for P - Mx review. A typical day in... more details
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.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
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