Sr. Study Manager, Global Study Operations (Also open in UK)

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.

Our Culture

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 SummaryFor assigned study(ies), the Sr. Study Manager (SM) is accountable for day-to-day Global Study Operations 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. SM 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. SM 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 ke