Associate Director, Clinical OperationsLocation San Rafael, California 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.
As a important function within BioMarin’s Worldwide Research & Development Group, the Clinical Operations Department is responsible for strategic direction on the feasibility, design, and conduct of clinical studies, and ensures operational excellence with clinical trial execution. The Associate Director, Clinical Operations, takes on a leadership role in program level strategy and execution to ensure the highest quality of clinical operations deliverables for a program. Come join our team and make a meaningful impact on patients’ lives.
Program Planning & Management:
- Core member of the Clinical Development Team (CDT), and agenda-driven member of the Core Team
- Provide strategic input and expertise on all CLO matters (i.e. feasibility, protocol design, study management, patient recruitment, study execution timelines, budgets, CRO and vendor management, and risk mitigation) for all clinical trials being conducted under the purview of the CDT
- Function as the liaison between the CDT and Study Execution Teams (SETs) for all clinical operations and study quality matters; Escalate issues/obstacles of strategic importance and study quality to the CDT for review, discussion and mitigation planning
- In collaboration with CLO functional management, coordinate provision of resources required in support of all clinical trials under the purview of the CDT
- Oversee and ensure the timely and quality execution of all studies under the purview of the CDT according to the study protocols, study execution plans, and GCP guidelines (including BioMarin SOPs, ICH, FDA and other health authorities (HAs))
- Contributes to the development and maintenance of the clinical development strategy (i.e., CDP) and execution planning for the program
- Escalation point for any CLO issues that have a significant impact on overall study or program timelines, other functions, budget or quality as per the CDT Charter
- Oversee the development of cross-functional efforts to define enrollment strategies of studies in the program
- Participate and contribute in key strategic program planning meetings (such as, advisory board, steering committee), as needed
- Communicate key study and program metrics to executives, cross- functional stakeholders, and the CDT
- Oversee CLO CRO and other vendor relationships for all studies in the program
- Ensure appropriate CLO vendor mgmt. activities are occurring across all studies
- Escalation point for any vendor issues that may impact study or program deliverables in collaboration with DevSci Business Operations (BizOps)
- Contribute to vendor selection decisions as appropriate
- Ensure appropriate functional or cross-functional governance is in place for any vendors that support multiple studies or functions in collaboration with BizOps
- Oversee and provide guidance to Study Execution Team Leads (SETLs) and Study Operations Leads (SOLs) under the purview of the CDT, holding them accountable for achieving assigned deliverables within timelines & budget, and in accordance with BioMarin’s quality standards.
- Review and confirm risk identification and mitigation planning is in place for each SET as well as for the overall program
- Ensure timely and effective communication among the CDT, Clinical Operations management, and the SETLs, as appropriate
- Ensure program is focused on inspection readiness from a clinical operations perspective
Cross- Functional Representation:
- Provide CLO expertise and decision-making ability and authority to the CDT (both strategic and operational), ensuring alignment within CLO Sr. Management
- Facilitate timely and effective communications of CDT decisions and progress to CLO, as well as communicating significant CLO decisions and issues (including those of any functional area sub-teams or committees) back to CDT
- Contribute to the establishment of CDT goals that are aligned with Corporate and Global Clinical Development goals and that SETs and other GCD functional teams are executing to optimally achieve those goals.
- In conjunction with SETLs, provide updates to SETs on corporate perspectives and ensure alignment of Corporate, GCD and SET goals
- Support and enable “Lessons Learned”, as conducted by the CDT, SETs and functional partner teams
- Manage up to 4 direct reports; actual number of direct reports may vary depending on business needs.
- Oversee, train, and mentor all CLO staff contributing to studies supporting the program & CDT
- Ensure compliance with GCPs as promulgated by ICH E6 and other relevant local, regional or national regulations regarding clinical study conduct and protection of human subjects
- As a member of the CLO Leadership team, assist the VP, CLO in defining and implementing departmental strategy and mission, including resource and budget management.
- Lead and contribute to departmental and cross-functional improvement activities
- Minimum of 10 years of biopharma industry experience
- Requires 10 years of relevant clinical research experience, including management of clinical trials.
- Minimum of 5 years of line management experience
- Bachelor’s degree in a biomedical science or relevant scientific discipline is required, and an advanced degree is preferred.
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.