Director/Sr. Director, Clinical OperationsLocation San Rafael, California Workstyle Open to Hybrid Apply
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development 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 rare diseases. Come join our team and make a meaningful impact on patients’ lives.
The BioMarin Clinical Operations (CLO) function is tasked with providing strategic direction on the feasibility, design, and conduct of clinical studies and drives the delivery of high-quality data to support the registration and approval of clinical development assets. The function achieves this through the development and operationalization of Clinical Development Plans, study planning and delivery, cross-functional leadership of Study Execution Teams, operational trial expertise, and vendor management and oversight.
The Director in Clinical Operations is expected to have a multifaceted role including program, project and line management. 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 will be essential to their success. In addition, the Director is an accomplished manager and leader of people in the organization.
From a technical standpoint the ideal candidate has experience with recruitment and retention practices, clinical trial diversity practices, a strong interest in process improvement projects and cross functional initiative leadership along with skills in metrics and dashboard creation and use of innovative technology to reduce burden for sites, vendors, and staff 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
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 enrollment according to projections.
Overall program operational accountability:
- Provide program-level oversight, leadership, and direction, ensuring that Clinical 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 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
- Drive and implement critical cross functional initiatives across the portfolio of programs and/or Clinical 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
- BA/BS degree (advanced degree preferred) with a focus on life sciences, nursing, or related technical or scientific discipline
- 12+ 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
- 3 or more years of people management experience
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
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.