BeOne Medicines ยท 3 days ago
Senior Manager, Clinical Supply Chain
United States
Full-time
Remote
Senior Level
$132K/yr - $177K/yr
5+ years expBeOne Medicines is a company focused on fighting cancer and is seeking a Senior Manager for their Clinical Supply Chain. This role involves managing drug supply activities for clinical studies, ensuring accurate supply to patients while minimizing waste, and leading staff in process improvements.
Pharmaceuticals
Responsibilities
Represent the Clinical Supply Chain on Clinical Study Teams (CST) and provide a high service level to internal stakeholders (e.g. Clinical Operations, Regulatory, Quality, CMC)
Work with Clinical Operations to understand clinical demand requirements and ensure alignment with study teams to supply plans and timelines
Create supply and inventory plans and develop production schedules for clinical trial materials
Monitor schedule adherence of production schedules and make course corrections if needed
Manage GMP inventory throughout the supply chain, develop inventory reports, manage upcoming expiry, and ensure drug accountability
Manage the relationship and oversee daily activities for FG label & pack CMOs and distribution vendors
Responsible for investigation of exceptions to determine root causes, implement CAPAs and drive closure
Ensure label text and proofs are in accordance with applicable rules, regulations, product specifications, and clinical study protocol(s)
Coordinate review and approval of labels with stakeholders (e.g. Regulatory, Clinical Operations, CRO) and CMOs
Support IRT user acceptance testing, develop IRT supply strategy (DNX parameters), and oversee ongoing supply activities in system
Coordinate and track bulk shipments to CMOs, depots, and vendors. Maintain and track import licenses
Develop supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans
Lead cross functional projects and process improvements related to drug supply
Assist in the creation of Standard Operating Procedures
Additional responsibilities as required
Leads staff who are in supportive roles for supply planning and business process development
Qualification
Required
Bachelor's degree with 7 years progressive experience in Supply Chain, preferably within the biotech, pharmaceutical, CRO industry or Master Degree in Business Administration, Operations Management, or similar education required, with 5 years progressive experience in Supply Chain, preferably within the biotech, pharmaceutical, CRO industry
Demonstrates knowledge of global clinical trials and the drug development process
Experience in vendor oversight and managing external partnerships and relations
Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, and GCP)
Experience in deviation investigation and CAPA implementation
Knowledge of IRT system setup and functionality and proficiency with Excel modeling
Strong analytical, problem solving, and communication skills
Strong collaboration and excellent team skills to be successful in cross-functional and multi-cultural teams
Efficient in Microsoft Word, Excel, and Outlook
Benefits
Medical
Dental
Vision
401(k)
FSA/HSA
Life Insurance
Paid Time Off
Wellness
Company
BeOne Medicines
BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more accessible to cancer patients worldwide.
10001+ employees
H1B Sponsorship
BeOne Medicines has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
Funding
Current Stage
Late StageCompany data provided by crunchbase