Scientist II / Senior Scientist I, Clinical Pharmacology
This Scientist II / Sr. Scientist of Clinical Pharmacology will be responsible for the design, execution, interpretation and reporting
clinical pharmacokinetic/pharmacodynamic (PK/PD) studies. This includes the assessment of PK/PD relationships of biologics,
small molecule, and
drug candidates throughout all stages of development
(Research to Post-marketing).
The individual will
represent Clinical Pharmacology
on cross-functional drug development teams
and will drive Clinical Pharmacology strategy and execution. He/She will
assess and recommend dose levels and regimens for molecules in Phase 0-IV clinical development (including new indications for existing therapeutics). This assessment will require modeling/simulations and predictions of PK and PD.
The individual will be responsible for the planning, implementation and organization of clinical
pharmacology sections of
regulatory filings along with presentation of PK/PD data to internal cross-functional teams, external collaborators, US and ex-US regulatory authorities and the scientific community.
RESPONSIBILITIES : LI-JL1
on multi-disciplinary drug development teams and lead departmental sub-teams
Interact with pharmacologists, toxicologists, medical directors and regulatory affairs personnel within BioMarin for the timely completion of clinical and nonclinical studies and regulatory filings
Design and interpret PK/PD studies in support of molecules in nonclinical
Model, simulate and predict nonclinical and clinical data to drive decisions on dose and frequency of dosing
Provide expert PK/PD advice to cross-function project teams
Interact with external collaborators, multi-company project teams and outside vendors and CROs as needed.
Write reports, sections to INDs, NDAs, etc. and publish findings at the appropriate time.
of industry experience (at the Scientist II level)
with a strong
background in Pharmacokinetics and Pharmcodynamics to support the
biologic drug development process
Experience in clinical/nonclinical PK/PD study design, implementation and interpretation
for biologic drug candidates; Experience in assessing the impact of immunogenicity on PK and PD
Extensive hands-on experience with non-compartmental and compartmental PK/PD analysis using WinNonlin software
Experience with population PK/PD
modeling and simulation
using appropriate software such as NONMEM/R/SPLUS
in clinical drug development
Experience with GLP procedures and documentation
and familiarity with FDA and EMA Clinical Pharmacology related guidances .
Experience with preparing clinical pharmacology/PK/PD related sections in regulatory submissions (e.g.
IB, IND, NDA,
Excellent writing and verbal communication skills both cross-functionally within BioMarin as well as outside to various regulatory agencies
Pharm.D. or Ph.D. in Pharmaceutical Sciences, Pharmacology
or related field such as Bioengineering. ~BIO