Sr. Director Pharmacometrics--remote position
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
[email protected]<mailto:[email protected]> 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:[email protected]]
Brenda Roseberry
Division Manager-Scientific
Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers
720-328-9526 - Office
315-415-4353 - Mobile
720-475-1176 - Fax
[cid:[email protected]]
http://www.linkedin.com/profile/view?id=19937880&authType=name&authToken=b5d_