Scientist II / Senior Scientist I, Clinical Pharmacology

Location
San Rafael, CA, United States
Posted
Jan 08, 2019
Ref
20771
Required Education
Doctorate/PHD/MD
Position Type
Full time
BioMarin's Clinical Pharmacology Team - A Unique Opportunity with Impact:

The role of Clinical Pharmacology at BioMarin is unique and broad in scope. We are driven by the substantive impact of our work on patient lives and their families in the rare, often pediatric disease space. Enabled by expertise across therapeutic platforms (e.g., small molecule, protein, oligo and gene therapy), our approach to solving complex biological issues is independent of treatment modality. The Clinical Pharmacology team at BioMarin is a great unit of diverse and strong thinkers who are involved from discovery through development and post-marketing. This breadth of experience across the complete life cycle of diverse assets truly exposes one to the multidisciplinary function that is Clinical Pharmacology. We hope that you will review our team's impact and consider us in your career journey.

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