Description

BioMarin Pharmaceutical Inc.
At BioMarin, we recognize and value each employees contribution toward reaching our corporate missionto develop and commercialize innovative biopharmaceuticals for serious diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them.

Today, with three products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us.

EEO/M/F/D/V
To apply: Visit www.BMRN.com Job Code 09-0116

SUMMARY

The Senior/Principal Scientist of Pharmacokinetic will be responsible for the design, execution, interpretation and reporting of nonclinical and clinical pharmacokinetic studies. This includes the assessment of nonclinical and clinical pharmacokinetic/pharmacodynamic relationships of recombinant protein and small molecule drug candidates that are situated throughout all stages of development (Phase 0-IV). Additionally, the individual will assess and recommend dose levels and regimens for molecules in Phase I-IV clinical development (including new indications for existing therapeutics) by working in close partnership with nonclinical pharmacologists and toxicologists, bioanalytical research scientists, formulation and process scientists, medical directors, biostatisticians and project teams. This assessment will require modeling, simulations and predictions of PK and PD to make decisions on dose and frequency of dosing. Additionally, the individual will be responsible for the planning, implementation and organization of regulatory filings along with presentation of data to cross-functional core teams and subteams, external collaborators, US and ex-US regulatory authorities and the scientific community. This individual will also be directly involved in participating/leading project sub-teams and representing the function on cross-functional project teams. This individual will also scientifically characterize the mechanisms of absorption, distribution, metabolism, and elimination of drug candidates in various nonclinical models. The individual will also provide recommendations and implement testing of putative formulation changes for drug candidates in order to optimize biological characteristics. The individual will play a critical role with respect to molecule selection for initial and continued drug development, pharmacokinetic and pharmacodynamic modeling, safety assessment, and communication of results to various regulatory agencies and corporate partners.

RESPONSIBILITIES

Design and interpret pharmacokinetic studies in support of molecules in nonclinical and clinical development.
Model, simulate and predict preclinical and clinical data to drive decisions on dose and frequency of dosing
Interact with pharmacologists, toxicologists, medical directors and regulatory affairs personnel within BioMarin for the timely completion of PK studies and regulatory filings.
Participate in multi-disciplinary drug development teams and lead 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

Requirements

EDUCATION

Required: Ph.D. in a pharmaceutical science or related field.

EXPERIENCE

Required: At least 6 years (Sr. Scientist)/8-10 years (Prinicipal Scientist) of industry experience.
Required: Strong pharmacology background with extensive knowledge of pharmacokinetic concepts and pharmacokinetic analysis software (e.g., WinNonlin).
Required: Excellent writing and verbal communication skills both cross-functionally within BioMarin as well as outside to various regulatory agencies.
Required: Extensive nonclinical and/or clinical PK study design, implementation and interpretation; experience in modeling and simulations
Preferred: Population PK experience
Preferred: In vitro/in vivo ADME experience
Preferred: Pharmacokinetic experience with biologics and the associated immunogenicity issues is a plus.
Required: Experience with GLP procedures and documentation or equivalent familiarity with FDA guidances.

To apply: Visit www.BMRN.com Job Code 09-0116