Director, Global Study Operations, Program Lead

The Director in Global Study Operations (GSO) is expected to have a multifaceted role including program, project, and managing large global teams.

The expectation is that they have proven ability at the clinical program lead role and can be relied upon to lead large and complex programs.

In a wider context the Director is an excellent communicator, who can efficiently synthesize information from a variety of sources proactively identifying interdependencies and leveraging a solutions-focused mindset to develop options to work through setbacks.

The ability to maintain a strong leadership presence, display sound decision-making and presentation skills, and is highly adept at representing the program both internally and externally as essential components of their success.

In addition, the Director is an accomplished manager and leader of people in the global organization. From a technical standpoint the ideal candidate has experience with Early-Stage clinical trial delivery, 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, and use of innovative technology to reduce burden for sites, vendors, and study teams alike.

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

• Decision Making, Strategic Thinking, and Problem Solving
• Influence and Collaboration
• Agility and Proactivity
• Leadership and People Management

With advanced technical competencies in the following areas :

• Drug Development and Study Design
• Study Management and Execution
• Vendor Management and Oversight
• Data analytics / interpretation

Key responsibilities include but are not limited to : Clinical Development strategy and planning :

Contribute to the clinical development strategy for a program or programs providing input on the design and operationalization of the Clinical Development Plan (CDP) and supporting studies.

Provide operational expertise and guidance on all relevant program and study deliverables. Ensure development and implementation of recruitment and retention strategies as applicable to support enrolment according to projections.

Overall program operational accountability :

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 studies in a program.

Ensure effective communication across all key program stakeholders.

The primary point of escalation for program and study executional issues or risks related to deliverables, vendors, quality, timelines, and budget when staff or study team members are not able to resolve independently;

take ownership of appropriately escalated issues and drive to resolution.

Provides strategic and tactical input, guidance, and reports on program progress, risks, issues, metrics as needed to executive leadership across WWRD and BioMarin as appropriate

Departmental contributions :

• Drive and implement critical cross functional initiatives across the portfolio of programs and / or Global Study Operations to improve efficiency and effectiveness of clinical program development
• Assist with 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.
• Contribute to the development of a cohesive, balanced, and high-functioning team focused on driving continuous improvement for the organization.

Mentor and manage direct reports in alignment with a matrix team environment

Education

BA / BS degree (advanced degree preferred) with a focus on life sciences, nursing, or related technical or scientific discipline

Experience

14+ years clinical trial or drug development experience in biotechnology, pharmaceuticals, medical device organizations with BA / BS;

10+ years with MA / MS; 7+ years with PhD

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.