Director, Global Study Operations, Program Lead
3 weeks ago
- 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.
- 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
- BA/BS degree (advanced degree preferred) with a focus on life sciences, nursing, or related technical or scientific discipline Experience
- 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
- Contribute to and support the establishment and evolution of the use of innovative technology and systems management across the portfolio and department deliverables.
- Assist with change management and operational projects, including developing communications and supporting staff through change
- 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
- 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:
- 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.
- 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.
- 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:
- Data analytics/interpretation Key responsibilities include but are not limited to: Clinical Development strategy and planning:
- Vendor Management and Oversight
- Study Management and Execution
- Drug Development and Study Design
- Leadership and People Management With advanced technical competencies in the following areas:
- Agility and Proactivity
- Influence and Collaboration
-
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