Sr. Manager, Clinical Supply Chain
Location: San Rafael
Posted on: June 23, 2025
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Job Description:
Who 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. Job Title: Senior Manager,
Clinical Supply Chain Location: Hybrid which is 2-3 days onsite per
week in San Rafael CA About 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/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. IRT "Interactive Response
Technology" RTSM "Randomization and Trial" Supply Management
Keywords: , North Highlands , Sr. Manager, Clinical Supply Chain, Science, Research & Development , San Rafael, California
