What are the responsibilities and job description for the Clinical Supply Chain Manager position at AiCuris Anti-infective Cures AG?
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 to enhance 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.
- Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Supply Chain Management, Business, or related field; advanced degree preferred.
- 7–10 years of experience in Clinical Supply Chain Management or related roles within the life sciences industry.
- Strong knowledge of cGMP, GCP, GDP, ICH, FDA, and international regulatory and logistics requirements.
- Proven experience managing end-to-end clinical supply across global programs, including early access programs (EAP) and EU studies.
- Demonstrated success contracting, qualifying, and managing external clinical CPOs (for example Almac) and service providers for packaging, labeling, release, and distribution.
- Experience authoring and reviewing clinical and technical documents (e.g., label text, batch records, protocols, pharmacy manuals, IND/IMPD).
- Proficiency with IRT systems (selection, setup, configuration, and UAT testing).
- Skilled in supply forecasting, inventory management, and budget tracking.
- Strong organizational, analytical, and problem-solving skills.
- Excellent cross-functional collaboration and communication abilities.
- Ability to work independently and effectively in a fast-paced, cross-cultural environment
- Business fluent in English; German skills would be beneficial.
- Willingness to travel internationally.
- 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
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.
We believe in a culture of trust and transparency, where feedback is considered an opportunity to contribute to each other's personal and professional growth. We hire people who are collaborative, adaptable, communicate well, and love to learn.: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.