Scientist II / Senior Scientist I, Clinical Pharmacology
- Employer
- BioMarin Pharmaceutical Inc.
- Location
- San Rafael, California
- Start date
- Dec 4, 2018
View more
- Discipline
- Clinical, Clinical Research, Science/R&D, Biotechnology, Pharmacology
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Biotech Bay, Best Places to Work
Job Details
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
Company
BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.
Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.
Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.
- Website
- https://www.biomarin.com/
- Location
-
California
United States
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