Associate Director, Global Study Operations, Program Lead
Location San Rafael, California ApplyWho 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.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
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 inGlobal 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 identifyinginterdependencies andleveraging 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.
From a technical standpoint the ideal candidate has experience with early to late-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, 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
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-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
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.
For additional benefits information, visit: https://careers.biomarin.com/benefits.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.