Sr. Manager, Global Study Operations (GSO)

San Rafael, CA

Employer:

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 departmentprocess 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.
The salary range for this position is: $138,400 to $207,600. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

For additional benefits information, visit: https://careers.biomarin.com/benefits .

Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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