Director, People & Process Management, Global Study Operations

BioMarin Pharmaceutical Inc.•San Rafael, CA

About The Position

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 at BioMarin. The book of work includes the Phase -1 throughPost 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. Leadership Responsibility: 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 BioMarin and external training resources to develop staff. This role will ensure thoughtful definition and follow-through of Individual Development Plans (IDP) for direct reports.

Requirements

Minimum of 10 years in the pharmaceutical industry with a BA/BS degree with a focus on life sciences, nursing, or related technical or scientific discipline or 8 years in the pharmaceutical industry with a master’s degree
Minimum of 3 years management experience
Strong leadership attributes with excellence in line management, leading, coaching, and motivating a diverse team of individuals to reach their highest potential and successfully deliver on trial and program expectations.
Expertise in clinical trial management and vendor oversight
Solid business acumen with comfort in agile delivery in a complex learning environment, including the ability to produce and present clear, concise, professionally written communications and presentations to senior level executives and stakeholders.
Experience in working with Learning, Development, Engagement and Talent Strategy frameworks that welcome diversity, equity, and inclusion.
Effective written/verbal communication and people skills, with experience influencing and fostering collaborative relations with cross-functional stakeholders at all levels.
Innovative mindset with proven history of championing and supporting change to positively impact the business and its stakeholders.
Proactive, flexible, adaptive, and successful navigation of self and team through conflict or ambiguity to seek clarity, structure, and solutions.
Professional maturity to engage effectively and confidentially (as warranted) with employees, vendors,and team members.

Responsibilities

Partner with Phase Leads and Program Directors to align on program delivery expectations for direct reports, contribute to the development of process improvements and establish best practices to enhance the execution of trial delivery across the organization.
Effectively lead, develop, manage, and retain high performing teams; set vision and purpose through goals, clear and authentic communication.
Ensure visibility and alignment of corporate and functional goals with individual goals.
Build and manage effective working relationships with other line managers and leaders to ensure effective relations to support an engagement strategy that values diversity, inclusion, and equity.
Build and establish a positive team through management best practices including giving timely feedback, understanding retention issues, and ensuring clear priorities.
Build and establish a positive work environment by encouraging mutual respect, and accountability on a functional and project level, both locally and globally to implement and deliver the study.
Develop and manage partnerships with key enterprise business partners, SMEs, and stakeholders to support a strong network fostering an open and collaborative environment across the global network.
Collaborate with key business partners and contribute to the efforts and overall success of the wider Global Study Operations team.
Collaborate with stakeholders and cross-functional leads aligning on the management of project scope, plan resources, maintain schedules, and facilitate open bi-directional communication.
Contribute to the implementation of strategies and plans to improve complex drug development processes and capabilities.
Ensure compliance with all SOPs, ICH-GCP guidelines, regulatory authority regulations and patient safety standards in the conduct of global clinical trial execution.
Establish and maintain high quality clear work standards for projects while ensuring timely delivery of customer's business requirements within the specific business initiative and project timelines