Director, Clinical Supply ChainLocation Novato, California Apply
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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. Come join our team and make a meaningful impact on patients’ lives.
The AD/Dir, Clinical Supply Chain ensures uninterrupted clinical supply to a global patient population. This person is responsible for identifying gaps and inefficiencies, and establishing and implementing best-in-class clinical supply chain processes and solutions. He/she manages the Clinical Supply Chain team, which is responsible for end-to-end clinical supply chain management activities, including study start-up activities, demand planning, inventory management at clinical sites and sub-depots, IXRS configuration, CMO detailed and master scheduling, and clinical drug accountability and reconciliation.
- Development of the Clinical Supply Chain team through effective leadership and mentoring to become a global, high performing organization, including:
- Strong understanding of clinical study design, execution, and close-out
- Strong understanding and effective use of advanced supply chain management techniques and tools, including IXRS and ERP solutions
- Understanding of international and cold chain logistics
- Strong and proactive use of problem solving, communication, and leadership skills
- Collaboration and teamwork
- Identify gaps and inefficiencies, and establish and implement best-in-class clinical supply chain processes and solutions
- Build processes and relationships with Clinical Operations, contracted clinical research organizations (CRO’s), Study Site teams, CMO’s, and other external parties to create an integrated end‑to‑end clinical supply chain that is effective and adaptive to new challenges
- Partner with Clinical Operations to interpret clinical protocols, and identify clinical study assumptions, such as enrollment rate, number of sites, number of countries, patient weights, etc. and translate such information into reliable demand plans
- Collaborate with appropriate BioMarin groups and project teams to design supply strategies and clinical product configurations that successfully achieve corporate goals, supports trail design, and ensures subject compliance, while minimizing waste
- Work closely with Supply Planning, Product Supply Chain Owners, CMO’s and Logistics to ensure uninterrupted supply of study drug to patients, including:
- Overseeing clinical CMO scheduling activities and related S&OE meetings, to ensure required execution occurs.
- Ensuring appropriate inventory levels at sub-depots and clinical sites
- Identification of supply risk mitigation plans to ensure uninterrupted availability of study drug to patients, including determination of supply overage amounts by site and/or geography, as well as any early development supply needs
- Ensuring Regulatory and Quality requirements are considered and met
- Identifying changes to storage and shipping requirements, including enrollments in new countries
- Ensuring clinical to commercial transition plans are effectively coordinated
- Define site level supply handling procedures, including drug receipt, returns and destruction
Manage performance, costs and invoices related to clinical storage CMO’s
- Minimum 10 - 12 years’ experience in a supply chain field required, preferably in a pharmaceutical or biotech organization
- Minimum 5 years’ supervisory experience required
- Experience with Inventory Analysis and Management, and Master Scheduling required, 2 years minimum
- Working knowledge of current GMP/GCP regulations required
- Clinical supplies experience required
- Experience in ERP systems required
- IXRS experience highly desirable
- Distribution experience, including International and Cold Chain preferred
- Bachelors in science, engineering or supply chain related major required, Masters preferred
- Proficient in Operational Excellence, Lean Process development, Six Sigma tools and techniques is highly desirable
- APICS certification (CPIM, CRIM, CSCP) preferred
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.