BMRN GSO Job Description:  Associate Director, Program Lead, GSO-J

Who we are:

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating, and have few, if any, treatment options. BioMarin aims to improve life and health outcomes for people with rare diseases by advocating the use of innovative BioMarin therapeutics, advancing the standard of care, and providing personalized support and services globally.  

The BioMarin Global Study Operations (GSO) function is tasked with providing strategic direction on the feasibility, design, and conduct of global clinical studies and drives the delivery of the clinical studies resulting in high-quality data to support the registration and approval of clinical development assets. GSO-Japan has the responsibility to deliver the Japan component of the portfolio for both global studies where Japan is an included country, working with a global study execution team, and local Japan-only post-marketing studies (PMS).

About the Opportunity:   

The Associate Director Program Lead – Japan (AD PL-JPN) role is a unique multifaceted role within Global Study Operations Japan (GSO-J) including program, project, and people management along with proven experience working within and implementing GPSP procedures and requirements. 

The chosen candidate is expected to have proven ability and experience at the clinical program lead level and can be relied upon to lead and execute complex programs. Additionally, they will be able to demonstrate experience in direct people management and working within and in accordance with GPSP requirements.

In a broader context, the AD PL-JPN is an exceptional communicator who can efficiently synthesize information from various sources, proactively identifying interdependencies and leveraging a solutions-focused mindset to develop options for overcoming setbacks. The ability to maintain a strong leadership presence, display sound decision-making and presentation skills, and adeptly represent the program both internally and externally are essential components of their success.

The AD PL-JPN will collaborate with cross-functional teams both within the local Japan office and globally to ensure the successful execution of clinical programs, fostering a collaborative environment that drives innovation and excellence. The AD PL-JPN is an accomplished manager with proficient people management and cross-functional management experience within a matrix organization.

From a technical standpoint the ideal candidate has experience with early to late-stage clinical trial delivery and adherence to GPSP requirements, clinical trial recruitment and retention practices, clinical trial diversity practices, a strong interest in process improvement projects and cross functional initiative leadership, skills in metrics and dashboard creation, drive compliance and quality and use innovative technology to reduce burden for sites, vendors, and study teams alike. 

Within the role the candidate is expected to have advanced knowledge and experience in the following competencies:

• Communication and Collaboration
• Leadership
• Influence and Organizational Awareness
• Decision Making, Strategic Thinking, and Problem Solving
• Agility and Proactivity
• Fluent in business-level English (written and spoken)

With advanced technical competencies in the following areas:

• Drug Development and Study Design
• Product & Therapeutic Area Knowledge
• Vendor Management and Oversight
• Data analytics/interpretation

Key responsibilities include but are not limited to:

• People management:
  • Line management of up to 5 direct reports (both FTE and CW) of varying roles (Study Managers and Study Specialists)
  • Contribute to the development of a cohesive, balanced, and high-functioning team in Japan focused on driving continuous improvement for the organization
  • Mentor and manage Japanese staff in alignment with a matrix team environment

• Clinical program strategy for Japan:
  • Collaborate with local Japan leadership, US PDs, PLs and PPM to support APAC and global studies with APAC component.

• Advisor in discussions on which APAC CRO to consider for new programs
• Contribute to the APAC clinical development strategy for a program or programs providing input on the design and operationalization of the Clinical Development Plan (CDP) and supporting studies within APAC as required.
• Provide operational expertise and guidance on APAC-relevant program and study deliverables.
• Ensure development and implementation of recruitment and retention strategies as applicable to support enrolment in APAC according to projections.

• GSO representative for GSO-JPN within the Japan office
  • Responsible for representing GSO and other Global Development Operations (GDO) functions not represented locally in BMRN Japan /APAC (e.g. Business Operations) in cross-functional discussions within BMRN Japan leadership
  • Drive and implement critical cross functional initiatives across the APAC portfolio of programs and/or GSO-J to improve efficiency and effectiveness of clinical program development
  • Champion change management and operational projects, including developing communications and supporting staff through change
  • Contribute to and support the establishment and evolution of the use of innovative technology and systems management across the portfolio and department deliverables.

• Potential for GPSP responsibilities
  • May assume the role of GPSP supervisor
  • May be responsible for the implementation of all GPSP requirements

Overall program operational accountability for Japan:

• Provide program-level oversight, leadership, and direction, ensuring that Global Study Operations team members and the cross-functional Study Execution Team achieve assigned deliverables within timelines, budget, and in accordance with BioMarin’s quality standards.
• Ensure consistent study execution practices to drive successful outcomes and deliverables across all programs. Ensure effective communication across all key program stakeholders.
• The primary point of escalation in Japan for program and study executional issues or risks related to deliverables, vendors, quality, timelines, and budget when staff or study team members cannot resolve independently; take ownership of appropriately escalated issues and drive to resolution.
• Provide strategic and tactical input, guidance, and reports on program progress, risks, issues, metrics as needed to executive leadership across WWRD and BioMarin as appropriate

Education

• BA/BS degree (advanced degree preferred) with a focus on life sciences, nursing, or related technical or scientific discipline
• Fluent in business-level English

Experience

• 10+ years clinical trial or drug development experience in biotechnology, pharmaceuticals, medical device organizations with BA/BS; 8+ years with MA/MS;6+ years with PhD
• Relevant experience working within GPSP requirements for clinical trial delivery
• 3 or more years of people management experience 

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law. 

JD-Japan GSO AD                                                                                                                                                                                                 FINAL 24FEB2026