Scientist II / Senior Scientist I, Clinical Pharmacology

Location
San Rafael, California
Posted
Dec 04, 2018
Ref
20771
Required Education
Doctorate/PHD/MD
Position Type
Full time

POSITION OVERVIEW:

This Scientist II / Sr. Scientist of Clinical Pharmacology will be responsible for the design, execution, interpretation and reporting

of

nonclinical and

clinical pharmacokinetic/pharmacodynamic (PK/PD) studies. This includes the assessment of PK/PD relationships of biologics,

small molecule, and

gene-based

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

Represent

Clinical Pharmacology

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

and clinical

development

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.

EXPERIENCE

At least

3

years

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,

etc.)

Excellent writing and verbal communication skills both cross-functionally within BioMarin as well as outside to various regulatory agencies

EDUCATION:

Pharm.D. or Ph.D. in Pharmaceutical Sciences, Pharmacology

or related field such as Bioengineering. ~BIO