The Karyopharm Workplace
Karyopharm Therapeutics, Inc. (the "Company") is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law. Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities. If you require an accommodation in the application process, please contact a member of the Company’s Human Resources department.
Position: Clinical Supply Chain Manager
This role is responsible for ensuring continuous product supply for Karyopharm’s drug products (IMP) in support of clinical trials. The individual will work with internal and external customers and suppliers in order to accomplish project objectives. The individual will develop IMP packaging and distribution plans and manage Clinical Supplies documentation requirements. Responsible for monitoring inventory levels and providing feedback to the appropriate resources regarding expiry and resupply. In addition, the individual will support Clinical Supply Chain initiatives and continuous improvement activities.
- Review clinical trial protocols and understand impact on supply
- Partner with Clinical Operations to identify demand assumptions, such as enrollment rate, number of sites, number of countries, etc.
- Create, review and update the clinical supply and demand plans based on strategic elements/study forecasts from Clinical Operations for studies and/or programs
- Participate in cross-functional Project Team Meetings
- Ensure changes in supply configuration, trial design, enrollment timelines, manufacturing availability and regulatory requirements are considered
- Monitor inventory levels at depots and clinical sites through the life of a trial; take preventive actions to avoid potential supply issues
- Manage label development process and packaging timelines
- Coordinate US and international distribution and logistics with CMOs
- Develop IRT and participate in User Acceptance Testing
- Develop and maintain applicable metrics
- Review and update SOPs and identify the need for a assist in establishing new departmental procedures
- Bachelor’s degree in life sciences or business major
- 3-5 years of pharmaceutical industry experience within supply chain management (oncology and solid oral dosage form experience preferred).
- Experience in CMO management, including labeling, packaging, and distribution in North America and Europe
- Experience with IRT system and implementation
- Knowledge of cGMPs and relevant FDA and EU Regulations
- Familiarity with US and EU regulatory agencies and their guidance
- Ability to communicate effectively both orally and in writing, both internally and with external vendors and partners
- Ability to multi-task and work in a fast paced and dynamic environment
- Strong working knowledge of standard business software, including MS Excel, Word, PowerPoint and Project
- Strong analytical and organizational skills
- Travel domestic and international – possibly up to 10%
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