Associate Director, Global Study Operations

Associate Director, Global Study Operations People & Process Management

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 Global Study Operations (GSO) People & Process Management team is responsible for direct line management activities as well as driving the strategic development and implementation of operational solutions in support of trial delivery and managing the team for consistent execution. This includes the utilization of role-specific processes executed consistently across the book of work, with a focus on continuous improvement based on lessons learned, new innovative execution modalities to keep BioMarin ahead of the industry in trial delivery.

The Associate Director (AD) will fulfill the role of mentor, coach, and line-manager for 8-12 Study Specialists (equivalent to clinical trial specialist), based in the UK and Japan. This includes accountability 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 Phase -1 through Post Approval space with the program teams being accountable for the successful operational delivery of all the assigned studies within their program(s).

The ideal PPM candidate is a technically strong leader with experience managing diverse teams to meet clinical trial and program goals. Strong communication skills are essential, including coaching and mentoring direct reports to meet business needs and their individual development. Prior experience in developing talent and building high-performing teams is required. In addition, the role includes development of process improvements, training curriculum and innovative approaches to continuously improve the execution of trial delivery. This role reports to the Head of People and Process Management.

While not directly accountable for program deliverables, the role involves close collaboration and alignment with program directors, leads, and study managers to ensure Study Specialists are meeting timely execution of study deliverables. The PPM manager also contributes to internal process improvements, cross-function working groups, training initiatives and supports staff development through Individual Development Plans (IDPs), leveraging both BioMarin and external resources.

Role Specific Minimum Requirements:

• 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.

Key Responsibilities may include but are not limited to:

• 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.

Process Management focus:

• 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.

Experience:

• Minimum of 8 years in the pharmaceutical industry with a BA/BS degree with a focus on life sciences, nursing, or related technical or scientific discipline or 6 years in the pharmaceutical industry with a master's degree
• Minimum of 2 years management experience, greater than 2 is preferred

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.