About this role
Description
Who We Are
BioMarin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the San Rafael, California-based company has a proven track record of innovation, with multiple commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that have a profound impact on patients..
About Research and Development
From research and discovery to post-marketing clinical development, our R&D engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing breakthrough medicines that provide meaningful advances to patients living with rare genetic conditions.
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CONTRACT TEMPORARY - APPROX 6 Months
*Hybrid Role***
***Onsite in San Rafael on Tuesday and Thursday***
Sr. Study Specialist, Global Study Operations
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 aims to
improve life and health outcomes for people with rare diseases by advocating the use of innovative BioMarin
therapeutics, advancing the standard of care, and providing personalized support and services globally.
The BioMarin Global Study Operations function is tasked with providing strategic direction on the feasibility,
design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration
and approval of clinical development assets. The function achieves this through the development and
operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of
Study Execution Teams, operational trial expertise, and vendor management and oversight.
Role Summary
The Sr. Study Specialist (SS) significantly contributes to or leads tasks related to the oversight of site monitoring,
vendor management, and other activities as delegated by the Study Manager or Program Lead (PL). This may
include contributing to and/or supporting study related matters that impact study participant safety, data
integrity, study timelines, quality, and budget. The Sr. SS will demonstrate a greater level of independence in
executing assigned tasks and manage more challenging or complex vendors, sites, regions, including issue
escalations from CROs and effective relationship management with Key Principal Investigator(s). Within the
role, the candidate is expected to demonstrate and have proficient knowledge and experience in the following
competencies:
About BioMarin
Biotech developing enzyme replacement and gene therapies for rare genetic diseases. Headquartered in San Rafael, CA.
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