Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, and a diverse pipeline of early- to late-stage assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .
Job Overview
We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Clinical Supply Chain . The Senior Manager, Clinical Supply Chain is responsible for managing drug supply planning, inventory control, and distribution activities including label/pack scheduling, issue resolution, change implementation, vendor oversight, and scope review related to clinical supplies on multiple clinical programs. In addition, working closely with CMC, Regulatory Affairs, Quality Assurance, Clinical Operations, and /or SMPA external partners and CMOs, as needed, building strong working relationships, support study project teams and ensure timely Investigational Product (IP) for clinical trials.
Job Duties and Responsibilities
Lead and manage end-to-end Clinical Supply Chain activities (planning, packaging and labeling, distribution, returns and destruction) for assigned clinical programs in early and late phases.
Develop and manage supply forecasts, supply plans, and timelines in collaboration with Clinical and CMC.
Manage IP inventory levels at the depots and clinical sites; coordinate the inventory from manufacturer to depot or clinical sites.
Design and/or review label text to meet product requirements and ensure compliance with US and international regulations.
Ensures effective management of IP based on study timing and in accordance with clinical protocols, cGMP, GCP, ICH, FDA, and other applicable international, federal, and/or local regulations.
Collaborate closely with Clinical Operations, CMC, Regulatory Affairs, QA, and PDM to ensure advancement of clinical programs; ensure supplies readiness.
Coordinate with Commercial Supply Chain for use of commercial products used in clinical trial.
Manage clinical supply and logistics and resolve issues such as shipment delays, temperature excursions, import/export; work closely internal Trade Compliance & Logistics team.
Develop and manage clinical trial IRT systems, including specification development and User Acceptance Testing (UAT) and day to day management of IRT.
Participate in process improvements initiatives contributing to clinical supply chain; develop/implement Clinical Supply Chain SOPs as necessary.
Demonstrates a solid understanding of clinical study design (randomized, blinded, open label etc.) and execution.
Manage assign clinical trial contracts, purchase orders including invoices and budget for clinical supply vendor; participate in CSC budget and forecast planning.
Participate in CMO audits and/or technical visits as required.
Represent Clinical Supply Chain function at clinical trial meetings; communicate plan and timelines to internal and external customers and partners.
Manage, mentor, and develop staff as required.
Key Core Competencies
Demonstrate experience with clinical supply management planning, packaging, labeling, distribution and logistics.
Clinical Supply management experience using CMO strongly preferred.
Knowledge of GMP batch record development/review/approval process.
Knowledge of Interactive Response Technology (IRT) systems used in clinical studies.
Excellent project management and communication skills.
Education and Experience
BS/BA degree (Masters preferred) in life sciences or business major or equivalent required.
Minimum 8 - 12 (w/o Master's) or 6 - 8 years (with Master's preferred) years of relevant experience in biotech or pharmaceutical industry. Relevant experience includes Project Management, Pharmaceutical Development, Clinical Supply Management, and/or Clinical Trials Coordination.
At least 3+ years in Clinical Supplies Management.
At least 3+ years in Clinical Supplies Management.
Proficient knowledge of Microsoft Excel, PowerPoint, and Project software required.
APICS certification (CPIM, CLTD, CSCP) preferred.
The base salary range for this role is $151,280 to $189,100. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Confidential Data : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=3440496098&u=https%3A%2F%2Fwww.us.sumitomo-pharma.com%2F&a=https%3A%2F%2Fwww.us.sumitomo-pharma.com+) or follow us on LinkedIn (https://c212.net/c/link/?t=0&l=en&o=4190475-1&h=2504638834&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsumitomo-pharma-america%2F&a=LinkedIn) .
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
Our Mission
To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide
Our Vision
For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas
