Offer summary

Qualifications:

Bachelor’s degree in supply chain management, engineering, or life sciences; Master's degree preferred., Minimum of 15+ years of experience in clinical and commercial supply chain management., Advanced knowledge of clinical systems and tools such as IRT and Veeva., Strong understanding of regulatory frameworks including GMP, GDP, and GCP..

Key responsabilities:

Lead all aspects of clinical supply chain management to ensure timely and compliant delivery of clinical products.

Develop and implement clinical supply chain strategies aligned with global clinical trial requirements.

Oversee vendor management and ensure adherence to service level agreements and key performance indicators.

Ensure inspection readiness for regulatory audits and compliance with GxP standards across all clinical supply activities.

Job description

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.

Sr. Director, Clinical Supply Chain

Reporting to the VP of Global Supply Chain, the Senior Director, Clinical Supply Chain will lead all aspects of clinical supply chain management, ensuring that clinical products are delivered on time, in compliance, and aligned with global clinical trial requirements. This role involves strategic oversight of supply planning, manufacturing, vendor management, and logistics, with a focus on innovation, efficiency, and risk mitigation. The Senior Director will manage a high-performing team and serve as a key partner across internal and external stakeholders to support company goals.

Primary Responsibilities:

Strategic Leadership

Develop and lead clinical supply chain strategies to support global clinical trials, aligning with clinical, regulatory, and corporate goals, ensuring uninterrupted clinical supply
Build and communicate a vision for an efficient, scalable clinical supply chain process that supports early- and late-stage clinical trials for a growing pipeline.
Drive cross-functional collaboration with Clinical Operations, Quality, Regulatory Affairs, Manufacturing, and other internal & external stakeholders.
Partner with Clinical Operations to align on demand assumptions throughout entirety of studies.
Builds and leads the team of Clinical Supply Chain professionals, through strong development and mentoring while creating a culture of high accountability and innovation.
May lead large complex projects within department and represent GCSC in cross-functional projects.

Operational and Technical Oversight

Clinical Manufacturing Planning: Oversee packaging and labeling planning activities for clinical trial materials including the sustainment of the Clinical-Integrated Business Planning process.
IRT and Systems Management: Lead the development, implementation, and user acceptance testing (UAT) for IRT systems, ensuring effective tracking, randomization, and clinical inventory management.
Execute end to end clinical supply planning and decision-making, including demand forecasting, simulation, risk assessment, and resource allocation.
Labeling: Oversee the creation and approval of clinical supply labeling, including translations and compliance with country-specific regulations.
Inventory and Returns: Oversee end-to-end site and depot returns, destruction of clinical trial materials, and reconciliation of inventory for trial lifecycle management.

Vendor and Supplier Management

Oversee performance and delivery from Clinical Logistics Service provider and other suppliers, ensuring adherence to Service Level Agreements (SLAs) and Key Performance Indicators (KPIs).
Execute comparator sourcing program in support of the Clinical operations ensuring on time supply.

Regulatory and Compliance

Ensure inspection readiness for regulatory and compliance audits, preparing documentation and collaborating with cross-functional teams to address compliance issues related to clinical supply chain.
Oversee compliance with GxP standards, including GMP, GDP, and GCP, across all clinical supply activities.
Identify potential risks to the supply chain and develop proactive mitigation strategies to ensure uninterrupted supply.

Education:

Bachelor’s degree in supply chain management, engineering, life Sciences. (Master's degree preferred).

Experience

Minimum of 15+ years of direct experience in clinical and commercial supply chain management
Advanced knowledge of systems and tools in support of Clinical space such as IRT, Veeva (or equivalent quality docs).
Strong understanding of regulatory and compliance frameworks (GMP, GDP, GCP)
Leadership of cross-functional teams, and enterprise project including M&A
Proven record of delivering results and influencing at the enterprise level to drive key objectives
Versatile and innovative leadership, with focus on building a continuous improvement culture
Demonstrated experience of leading diverse and global high performing teams

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.

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