Job Description
The Scientist II/Senior Scientist will be responsible for the design,
execution, interpretation and reporting of clinical pharmacology and
clinical/nonclinical pharmacokinetic/pharmacodynamic (PK/PD) studies. This
includes the assessment of PK/PD relationships of recombinant protein and small
molecule drug candidates that are situated throughout all stages of development
(Phase 0-IV). The individual will assess and recommend dose levels and
regimens for molecules in Phase 0-IV clinical development (including new
indications for existing therapeutics) by working in close partnership with
medical directors, clinical scientists, biostatisticians, bioanalytical
research scientists, pharmacologists and toxicologists, , formulation and
process scientists, and project teams. This assessment will require modeling,
simulations and predictions of PK and PD, and make recommendations on dose
regimen for drug candidates in clinical development. Population PK/PD and
exposure-response analysis of drug candidates will be conducted as the programs
progresses in clinical development.. The individual will be responsible for
the planning, implementation and organization 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
· Design and interpret PK/PD studies in support of molecules in clinical
and nonclinical development.
· Model, simulate and predict nonclinical and clinical data to drive
decisions on dose and frequency of dosing
· Perform population PK analyses on drug candidates as they progress
through clinical development
· Provide expert PK/PD advice to cross-function project 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.
· Represent the Pharmacological Sciences Department on
multi-disciplinary drug development teams and lead departmental sub-teams.
· Interact with external collaborators, multi-company project teams
regarding and outside contractors
· Write reports, sections to INDs, NDAs, etc. and publish findings at
the appropriate time
EDUCATION
Ph.D. in a pharmaceutical science or related field.
EXPERIENCE
· At least 2 years for Scientist II or 5 years for Sr. Scientist of
industry experience.
· Required: Strong background in quantitative clinical pharmacology
analysis, pharmacokinetics and/or statistics with extensive knowledge of drug
development process
· Required: Extensive hands-on experience with population PK/PD and
exposure-response analysis using NONMEM/R/SPLUS software in clinical drug
development
· Required: Extensive hands-on experience with non-compartmental and
compartmental PK/PD analysis using WinNonlin
· Required: Excellent writing and verbal communication skills both
cross-functionally within BioMarin as well as outside to various regulatory
agencies.
· Required: Hands-on experience with preparing clinical
pharmacology/PK/PD related sections in regulatory submissions (i.e., IB, IND,
NDA, MAA, BLA).
· Required: Extensive clinical pharmacology and clinical/nonclinical
PK/PD study design, implementation and interpretation; experience in modeling
and simulation
· Required: Experience with GLP procedures and documentation or
equivalent familiarity with FDA guidance’s.
· Preferred: In vitro/in vivo ADME experience
· Preferred: Pharmacokinetic experience with biologics and the
associated immunogenicity issues is a plus.
To apply: link to job posting:
http://ch.tbe.taleo.net/CH04/ats/careers/requisition.jsp?org=BMRN&cws=1&rid=7464
Questions please contact:
Yvonne Gwinnell
Sr. Recruiter
Work: 415-506-3241
Email: [email protected]<mailto:[email protected]>
--
Yulan Qi
Senior Scientist I, PK/PD
BioMarin Pharmaceutical Inc.
105 Digital Dr.
Novato CA 94949
Tel: 415-506-3511
Cell: 415-827-9107
Email: [email protected]
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