HI all, I have a new Sr. Director role in Pharmacometrics available and there
is the opportunity to work remotely. Company headquarters are east coast United
States. Description is below and please email me at
brosebe...@cartermackay.com<mailto:brosebe...@cartermackay.com> for more info.
Alternatively my cell is 315-415-4353. This is a full time position with salary
and benefits. Director level will also be considered.
* Lead the pharmacometrics team and develop modeling and simulation
strategy in clinical development projects.
* Ensure the timely delivery of translational PK/PD, population PK, and
exposure response analyses to address key development questions.
* Apply model informed drug development approaches. Will work closely with
discovery, CMC, biomarker, preclinical development, clinical development, and
pharmacovigilence.
* Execute PK/PD modeling and simulation sections in regulatory submissions
and represent the Clinical Pharmacology function at meetings with regulatory
agencies and health authorities.
* Manage outsourced studies
* Mentor and supervise junior scientists
Knowledge/Skills/Abilities Required
* A Ph.D. in pharmaceutical sciences, engineering, or
mathematics/statistics with 8 to 15 years of modeling and simulation experience
in a pharmaceutical/biotech company
* Hand on experiences in developing population PK, PK/PD, disease
progression, exposure response, PBPK, and translational PK/PD models
* Expert knowledge of PK/PD software (WinNonlin, NONEM, Simcyp, NONMEM, R,
SAS and MATLAB etc)
* Knowledgeable in the regulatory requirements in IND and NDA
* Analytical thinker with excellent critical thinking and problem-solving
skills.
* Excellent verbal and written communication and skills including the
demonstrated ability to develop and deliver effective presentations to senior
leadership and with the ability to influence
[cid:1.1213385771@web31815.mail.mud.yahoo.com]
Brenda Roseberry
Division Manager-Scientific
Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers
720-328-9526 - Office
315-415-4353 - Mobile
720-475-1176 - Fax
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