Sr. Manager, Clinical Supply Chain

Company: BIOMARIN
Location: San Rafael
Posted on: April 15, 2025

Job Description:

Who We AreBioMarin 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 OperationsBioMarin'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.Job Title: Senior Manager, Clinical Supply ChainLocation: Hybrid which is 2-3 days onsite per week in San Rafael CAAbout the Opportunity: The Senior Manager, Clinical Supply Chain is responsible for leading and overseeing the clinical supply chain operations to support clinical studies with appropriate drug product supply. This role involves strategic planning, execution, and optimization of supply chain processes to ensure continuous drug supply from First Patient In (FPI) through completion of clinical trials. The Senior Manager will serve as the primary supply chain lead for multiple clinical programs and act as a key liaison between Technical Operations (TOPS), Clinical Operations, and study teams.Responsibilities:Strategic Drug Forecasting and Supply Planning:

• Develop and implement strategic drug forecasts and associated supply/distribution plans for multiple clinical trials.
• Initiate and oversee required activities and supply execution processes, maintaining oversight of production, release, and distribution steps necessary to ensure continuous drug supply.Team Leadership and Collaboration:
  • Lead and mentor clinical supply chain execution teams, providing guidance and support to ensure successful delivery of drug supply.
  • Collaborate with Clinical, Manufacturing, and Medical project managers as well as contract providers to create complex study forecasts and supply project plans.Clinical Supply Chain Execution:
    • Oversee clinical supply chain execution teams and actively support clinical study teams in all matters related to drug supply to meet portfolio demands for programs progressing toward critical milestones.Vendor Management:
      • Act as liaison with contractors (CMOs), manage supply budgets, explore opportunities to optimize budget, complete quarterly business and performance metrics, and negotiate quotes and work orders for new trials.Regulatory and Quality Compliance:
        • Work with Clinical Operations, QA, and Regulatory to develop kits and label text for multiple countries/regions and provide support for IND filings as required.
        • Assist in establishing and/or optimizing SOPs, protocols, and procedures for clinical trial material packaging, labeling, and distribution to ensure compliance with cGxP requirements.Documentation and Quality Systems:
          • Manage development of pharmacy manuals with appropriate internal subject matter experts.
          • Oversee Quality Systems required documentation, including Deviations, Investigations, CAPAs, Change Controls, Label and Product Specifications, and others as required.Project Management:
            • Develop and apply Project Plans and Schedules that represent the appropriate level of detail and task independency.
            • Ensure timely follow-up to all commitments in a project plan. Proactively address risk management issues and implement business continuity plans.Financial Management:
              • Prepare supply and cost forecasts as required. Identify cost reduction opportunities and develop and manage clinical supply budget.
              • Experience with financial management of supply chain activities including assisting with departmental budgeting and oversight of external contracts.Regulatory Inspections:
                • Serve as subject matter expert on behalf of TOPS for clinical trial supply during regulatory inspections.
                • Ensure appropriate documentation of IP supply activities is provided to clinical trial teams for Trial Master File.Additional Requirements for Senior Role:Leadership and Strategic Vision:
                  • Demonstrated ability to lead and inspire teams, fostering a culture of collaboration and excellence.
                  • Proven track record of developing and executing strategic plans that align with organizational goals and drive clinical supply chain success.Advanced Problem-Solving and Decision-Making:
                    • Strong analytical skills with the ability to identify and resolve complex supply chain issues.
                    • Experience in making high-impact decisions that enhance supply chain efficiency and effectiveness.Extensive Industry Experience:
                      • Minimum of 7 years of experience in a Clinical Supply Chain / Contract Manufacturing operation in the pharmaceutical or biotech industry.
                      • In-depth knowledge of global Health Authority requirements and industry best practices.Exceptional Interpersonal Skills:
                        • Strong interpersonal skills and awareness of the Emotional Quotient in a corporate environment to interact and resolve conflicts with many levels inside and outside of the Supply Chain Logistics organization internationally.Innovative and Forward-Thinking:
                          • Ability to drive innovation and continuous improvement within the clinical supply chain function.
                          • Experience in implementing new technologies and methodologies to optimize supply chain processes.Educational Qualifications:
                            • Advanced degree in Supply Chain Management, Business Administration, or a related field preferred.This job description outlines the key responsibilities and additional requirements for a Senior Manager of Clinical Supply Chain, emphasizing the leadership, strategic vision, and advanced problem-solving skills needed for this senior role.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/DisabledAn 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.The salary range for this position is: $134,400 to $201,600. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.For additional benefits information, visit: .
                              • Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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Keywords: BIOMARIN, San Rafael , Sr. Manager, Clinical Supply Chain, Professions , San Rafael, California