Sr. Manager, Global Study Operations (GSO)
Location: San Rafael
Posted on: June 23, 2025
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Job Description:
Who We Are BioMarin is a global biotechnology company that
relentlessly pursues bold science to translate genetic discoveries
into new medicines that advance the future of human health. Since
our founding in 1997, we have applied our scientific expertise in
understanding the underlying causes of genetic conditions to create
transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology,
we develop medicines for patients with significant unmet medical
need. We enlist the best of the best – people with the right
technical expertise and a relentless drive to solve real problems –
and create an environment that empowers our teams to pursue bold,
innovative science. With this distinctive approach to drug
discovery, we’ve produced a diverse pipeline of commercial,
clinical and preclinical candidates that have well-understood
biology and provide an opportunity to be first-to-market or offer a
substantial benefit over existing therapeutic options. About
Worldwide Research and Development From research and discovery to
post-market clinical development, our WWRD engine 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 genetic diseases. The BioMarin Global Study
Operations (GSO) 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 For assigned study(ies), the Senior Manager – Global
Study Operations (GSO) is accountable for day-to-day GSO study
execution and related deliverables and is the primary point of
contact within GSO for a study. Key responsibilities include
managing risks, issues and opportunities that impact timeline,
quality, and budget, overseeing the GSO study team, vendors and
CRO, as well as collaborating with cross-functional representatives
to execute on study deliverables. The Sr. Manager may be assigned
to and is responsible for managing complex early-stage studies,
late-stage, pivotal registration, or post approval studies, which
requires a greater depth of study execution experience. The Sr.
Manager plays a greater role in supporting the Program Lead (PL)
and/or Program Director (PD) in program wide activities, engaging
with leadership, and leading Study Execution Team (SET)
activities.Within the role the candidate is expected to show and
have proficiency and experience in the following competencies:
Core: Decision Making, Strategic Thinking, and Problem Solving
Influence and Organizational Awareness People Management Agility
and Proactivity Leadership Communication and Collaboration
Technical Data Analysis and Interpretation Study Management and
Execution Compliance and Quality Drug Development and Study Design
Product and Therapeutic Area Knowledge Responsibilities include but
are not limited to: Overall study execution oversight Provide
leadership, guidance, and direction to GSO staff assigned to
studies Facilitate cross-functional Study Execution Team (SET)
meetings Collaborate with cross-functional study members to drive
and execute on study deliverables, documents, and plans Proactively
identify, manage, and communicate cross functional study issues,
risks and mitigations in a timely manner Provide regular study
quality and progress updates to key stakeholders as needed Monitor
and act upon study metrics; review trend-identification and
analysis and provide targeted follow up where appropriate
Collaborate with other Study Managers to ensure consistency and
maintenance of the various study plans within a program Collaborate
with People and Process Managers of the Study Specialist staff to
support team member productivity and career growth Other
responsibilities Include: Contribute to the Study protocol and
Informed Consent Form (ICF) development Management of Study
Timeline Management of CRO and Vendors Management of Study
Lifecycle (start-up, enrollment, maintenance and close-out)
Oversight of Drug / Investigational Product (IP) process Management
of Study Budget Oversight of Feasibility, Recruitment and
Enrollment Oversight of Study Outcome and Data Deliverables Lead or
participate in program or study-specific projects that have a wider
impact Collaborate with study managers/cross-functional team
members to implement department process change and efficiencies
Education & Experience: BA/BS/BSc 7 years’ work experience in life
sciences or medically related field, including 4 years of
biopharmaceutical clinical research experience obtained working on
clinical trials in a biotech, pharmaceutical, or CRO Experience in
oversight of external vendors (e.g., CROs, central labs, imaging
vendors, etc.) Note: This description is not intended to be
all-inclusive, or a limitation of the duties of the position. It is
intended to describe the general nature of the job that may include
other duties as assumed or assigned. Equal Opportunity
Employer/Veterans/Disabled An Equal Opportunity Employer. All
qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, sexual orientation,
gender identity, national origin, or protected veteran status and
will not be discriminated against on the basis of disability.
Keywords: , North Highlands , Sr. Manager, Global Study Operations (GSO), Science, Research & Development , San Rafael, California
