Clinical Supply Chain Manager
Share
Job Location:
Marlborough, NH - USA
Monthly Salary:
Not Disclosed
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
Your mission
- Lead and manage all aspects of global Clinical Supply Chain operations for assigned clinical programs including planning forecasting packaging labeling distribution and returns/destruction.
- Develop and maintain global supply and distribution plans depot inventory management strategies and site resupply processes via IRT or manual systems.
- Collaborate with Clinical Operations CMC Regulatory and QA to determine required IMP quantities and ensure study readiness compliance and timely delivery of Investigational Medicinal Products (IMPs).
- Review study protocols to determine packaging labeling and distribution needs; design compliant label text and oversee approval and proofing.
- Support internal and external audits of CPO and other clinical supplies vendors CAPA management and inspection readiness (as necessary).
- Manage CPOs to ensure on-time and on-budget delivery of packaged and labeled IMPs.
- Coordinate shipping logistics import/export for IMP comparators ancillary supplies etc. across the clinical supply chains.
- Oversee the sourcing and delivery of commercially available comparators. Ensure comparator specifications meet study requirements.
- Coordinate QP release and ensure adherence to global regulatory and quality standards.
- Oversee IRT system development including User Requirement Specifications (URS) and User Acceptance Testing (UAT).
- Monitor global clinical inventory at depots and sites; manage supply chain exceptions such as temperature excursions or shipment delays.
- Participate in clinical trial team meetings to communicate supply strategies timelines and risk mitigation plans.
- Support financial management through purchase order tracking invoice reconciliation and budget forecasting.
- Identify and implement process improvements toenhance efficiency and compliance.
- Maintain accurate documentation in eTMF and ensure alignment with SOPs.
- Lead or assist with the creation and maintenance of Clinical Supply Chain SOPs.
Your profile
|
Why us
- Unique corporate culture:Scientific excellence a collaborative working environment and the passion to improve the lives of patients defines our work. With us you can work together with innovation awarded experts with the proven ability to translate science into commercial success. You can expect diversity inspiration as well as trustful collaboration.
- Development: We encourage people to grow and strongly support individual development and learning opportunities.
- Flexibility: Embracing flexible working accommodations we enable our people to integrate business into their personal life.
- Benefits: Competitive comprehensive benefit plan
About us
AiCuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product PREVYMIS marketed by our partner MSD treats CMV in a defined group of transplant recipients. Our pivotal phase 3 candidate Pritelivir aims to address recurrent and resistant HSV infections in a broad population of patients with weakened immune systems. For immunocompromised people an otherwise manageable infection can mean life or death. AiCuris with its expertise and growing pipeline is committed to providing therapeutic solutions for them now and in the future.
*AiCuris is an employer that supports equal opportunities diversity and inclusion. We welcome applications from people regardless of their national origin skin color religion gender age marital status disability sexual orientation gender identity or other legally protected characteristics.
Required Experience:
Manager
Key Skills
- Inventory Control
- Procurement
- SAP
- Supply Chain Experience
- SAP Supply Chain Management
- Production Planning
- Supplier Management
- ERP Systems
- Materials Management
- Logistics
- Manufacturing
- MRP
About Company
AiCuris is meeting the needs of the growing population of immunocompromised people who require precise therapies to effectively treat infection. Our flagship product, PREVYMIS, marketed by our partner MSD, treats CMV in a defined group of transplant recipients. Our pivotal phase 3 can ... View more
