Director Process Management, Global Study Operations

Who We Are

Bio Marin 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.

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 Associate Director (AD)/ Director (D), Global Study Operations, will fulfill the role of People & Process Manager of Study Managers, and is accountable for the consistent application of line management and process execution across the book of work for trial delivery  book of work includes the Phase
-1 through

Post Approval space with the Program Leads being accountable for the successful operational delivery of all the assigned studies within their program(s).

In this role the AD/D is the mentor, coach, and line-manager to Study Managers and Senior Study Managers. The AD/D will drive a positive team-based culture that is conducive to attracting, retaining, and motivating the Global Study Operations team.

In addition, the incumbent will be expected to contribute to the process development based on lessons learned, and innovative approaches to continuously improve the execution of trial delivery. This role combines the complexity of study execution in the early and late-stage development space, with the need for rapid development to support registration and the focus on life cycle management in the post approval space.

This role will report to the Head of People and Process Management.

The AD/D will manage between 8-12 Study Manager and Senior Study Manager level staff located globally. Those individuals will be interacting with cross-functional departments involved in the execution of clinical trials including but not limited to Clinical Development, Global Medical Affairs, Regulatory, Data Sciences, Clinical Supply Chain, Pharmacovigilance, as well as the executives that are the function heads of those departments.

The incumbent is a technically strong individual who has experience in leading a team of diverse individuals to successfully deliver on trial and program expectations. Communication skills at all levels of the organization are a critical aspect, requiring coaching of direct reports on how to flex presentations or discussions based on the level of the audience and the critical information needed by that audience.

The AD/D will be responsible for developing leaders of high-performing teams. Although not directly contributing to program goals the AD/D, GSO will work with direct reports and program directors to stay tightly connected to the on-time execution of deliverables.

The AD/D will contribute to or lead the development of internal training programs and leverage Bio Marin and external training resources to develop staff. This role will ensure thoughtful definition and follow-through of Individual Development Plans (IDP) for direct reports.

• Minimum of 10 years in the pharmaceutical industry with a BA/BS degree focused on life sciences, nursing, or a related technical or…