Scientist II / Senior Scientist I, Clinical Pharmacology
- Employer
- BioMarin Pharmaceutical Inc.
- Location
- San Rafael, CA, United States
- Start date
- Dec 12, 2018
View more
- Discipline
- Clinical, Clinical Research, Science/R&D, Biotechnology
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Biotech Bay, Best Places to Work
Job Details
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
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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