Associate Director, Clinical Supply Chain
Location United States, Remote
Workstyle Remote Only 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 Technical Operations
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.
About the Opportunity:
We are seeking a strategic leader for the Associate Director of Clinical Supply Chain Operations role, who will be responsible for the end-to-end clinical supply strategy and operational execution for global clinical portfolio. This role will drive the planning, coordination, and continuous optimization of investigational product (IP) supply to ensure timely, cost-effective, and compliant support of clinical development milestones. The Associate Director will serve as the clinical supply chain expert for complex programs, provide functional leadership within the department, and influence cross-functional and external partner collaboration to enable portfolio success.
This individual will play a critical role in program management, forecasting, scenario planning, and risk mitigation to ensure timely and uninterrupted availability of clinical trial materials (CTM). The successful candidate is both strategic and hands-on, with strong cross-functional collaboration skills and a deep understanding of the clinical development lifecycle, with ability to pivot based on the program needs. This is an exciting opportunity to contribute to a growing organization by applying best-in-class planning principles, digital technologies, and operational excellence.
Key Responsibilities:
Program Leadership and Cross Functional Collaboration
- Lead Clinical Supply Chain (CSC) operations for high complexity study and program, including strategy, budget and timeline development and adherence.
- Serve as the primary CSC representative for high complexity programs cross-functional governance forums.
- Drive cross functional collaboration with internal and external stakeholders to align supply strategy with development, regulatory, and operational needs.
- Influence program-level decisions to optimize timelines, patient access, and budget compliance.
Leadership and Team Development:
- Provide guidance and mentorship to team members, sharing best practices and tools to support excellent performance
- Foster a culture of integrity, transparency, high standards and high accountability, tackling challenges with a positive attitude and proposing alternatives to support company’s objectives
Clinical Supply Chain Operational Execution:
- End-to-end global clinical supply operations management, including but not limited to timelines to ensure alignment overall clinical development, manufacturing, pack and label, logistics, inventory, reconciliation, and IRT, maintaining Clinical Supply Plan up to date.
- Translate clinical protocols into integrated demand forecasts and risk-adjusted supply plans across regions.
- Support long-range planning, scenario modeling, and financial forecasting to ensure uninterrupted supply and potentially identify cost efficiency.
- Provide input to Interactive Response Technology (IRT) system design, testing. Maintain system to support supply tracking and randomization.
- Partner with key stakeholders in GEO (Global External Operations) to strategize and understanding status of manufacturing operations (DS, DP and FG), storage and distribution
- Monitor and track manufacturing timelines and ensure alignment with clinical supply needs.
- Responsible for inventory management at patient level to ensure zero out of stock situations.
Operational Excellence, Quality Compliance and Digital:
- Ensure compliance with global GxP, ICH, and regional regulatory requirements in clinical supply operations.
- Support regulatory filings and inspections as a subject matter expert; lead TMF preparation for investigational product supply.
- Dive SOP development, process improvements, and audit readiness to enhance operational scalability.
- Lead digital transformation initiatives including forecasting tools, dashboards, and AI-driven analytics to improve resilience and sustainability.
- Other duties as assigned
Must have: Minimum Requirements:
- Bachelor’s degree in a science-related field; advanced degree preferred
- 10+ years of experience in clinical supply chain, planning, or operations within the biotech/pharma industry
- Proven ability to lead cross-functional teams, influence stakeholders, and manage complex supply planning scenarios.
- Experience with digital planning tools (e.g., SAP, Tableau).
- Experience using the Smart Supplies Forecasting tool is preferred.
- Strong understanding of GxP, ICH, and regulatory requirements governing clinical supply activities
- Strong understanding of technical drug development is advantageous
Nice to have:
- Rare disease therapeutics clinical development
Workstyle:
- If an applicant lives within 100 miles of Novato, CA than the role reverts from fully virtual to hybrid onsite twice weekly at our Novato campus.
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.