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Scientist 1 or 2, Clinical Pharmacology (PK/PD studies)

Employer
BioMarin Pharmaceutical Inc.
Location
San Rafael, California
Start date
Dec 2, 2021

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Discipline
Clinical, Clinical Research, Science/R&D, Biotechnology
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Biotech Bay

Job Details

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.

SUMMARY

The Clinical Pharmacology Scientist I / Scientist II role will be responsible for the design, execution, interpretation and reporting of both nonclinical and clinical Pharmacokinetic/Pharmacodynamic (PK/PD) studies. With a growing portfolio, this individual will have the opportunity to work on small molecules, protein therapeutics and gene therapies across the development cycle (candidate selection to post marketing).  This individual will work with Clinical Pharmacology leaders on projects and provide support in characterizing the Clinical Pharmacology profile with an emphasis on dose and regimen selection.  Depending on experience, this individual could also serve as the Clinical Pharmacology representative on study and project teams and will contribute to the planning, implementation and organization of regulatory filings along with presentation of PK/PD data to internal cross-functional teams and external collaborators.    

RESPONSIBILITIES

  • Design and interpret PK/PD studies in support of molecules in clinical and nonclinical development across drug modalities (eg: small molecules, oligonucleotides, gene therapies) and therapeutic indications
  • Analyze, Model, simulate and predict nonclinical and clinical data to drive decisions on dose and frequency of dosing
  • Perform population PK and PK/PD analyses on drug candidates as they progress through clinical development
  • Interact with pharmacologists, toxicologists, medical directors and regulatory affairs personnel within BioMarin for the timely completion of clinical and nonclinical studies and regulatory filings
  • Represent Clinical Pharmacology on multi-disciplinary study teams with a potential to represent the function on project teams
  • Write protocol sections, analysis plans, reports, sections to INDs, NDAs, etc.

EXPERIENCE

Required

  • 0 to 5 years of industry experience with a strong background in Pharmacokinetics and Pharmacodynamics
  • Strong training in PK/PD analyses with a preference for population-based modeling and simulation
  • Extensive hands-on experience with non-compartmental and compartmental PK/PD analysis using WinNonlin and NONMEM software
  • Excellent writing and verbal communication skills
  • Ability to work in a matrix environment and with different leadership styles
  • Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated

Preferred

  • Experience with therapies in neurological and/or cardiovascular disorders
  • Post-doctoral and/or some industry experience

EDUCATION

  • Ph.D. in a Pharmaceutical Science, Pharmacology or related field such as Bioengineering with an emphasis in PK/PD modeling
LEVEL GUIDELINES:

Scientist 1:

  • PhD or equivalent relevant experience, plus 0-2+ years industry experience

Scientist 2 :

  • PhD or equivalent relevant experience plus 2-5+ years industry experience




We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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.

Company info
Website
Location
California
United States

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