Associate Director, Global Study Operations, Program Lead

Who We Are

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.

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 **Associate Director** in **Global Study Operations**(GSO) is expected to have a multifaceted role including program, project, and team management. The expectation is that they have proven ability at the clinical program lead role and can be relied upon to lead and execute complex programs. In a wider context the **Associate 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. The Associate Director will collaborate with cross-functional teams to ensure the successful execution of clinical programs, fostering a collaborative environment that drives innovation and excellence. The **Associate Director** is an accomplished manager with proficient people management and cross-functional management experience within a matrix organization.
- Communication and Collaboration
- Leadership
- Influence and Organizational Awareness
- Decision Making, Strategic Thinking, and Problem Solving
- Agility and Proactivity

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**:
**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
- 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.
- Contribute to the development of a cohesive, balanced, and high-functioning team focused on driving continuous improvement for the organization. Mentor and manage staff 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**
- 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
- 3 or more years of team management experience

Note: This description is not intended to be all-inclus