Formycon is an international leading, independent developer of high-quality biopharmaceutical medicines, especially biosimilars. With an experienced team comprised of around 240 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.
Our focus is on treatments in ophthalmology and immunology as well as for other key chronic diseases. Formycon is making a major contribution towards providing as many patients as possible with access to vital and affordable medicines.
To support our clinical operations team in Martinsried near Munich, we are looking for suitable candidates for this full- or part-time (min. 32 hrs/week) and permanent position, to begin work as soon as possible.
Your responsibilities
As an experienced and highly skilled Senior Clinical Trial Supply Manager (gn) you will lead the planning, execution, and oversight of the supply chain for our clinical trials. In this critical role, you will develop supply chain strategies, manage global logistics, and ensure that all clinical trial materials are available in a timely and compliant manner. You will act as a key liaison between internal teams and external vendors, playing a critical role in the success of our clinical programs. This includes the following tasks:
- Supply Chain Leadership: Lead the design and implementation of clinical trial supply chain strategies across multiple global trials. Ensure alignment with overall clinical and corporate objectives.
- Global Vendor & Logistics Oversight: Manage relationships with external vendors, including packaging, labeling, storage, and distribution partners. Ensure compliance with regulatory standards for investigational products.
- Inventory & Demand Planning: Lead demand forecasting and inventory management to ensure uninterrupted supply of trial materials to clinical sites while at the same time preventing loss of unused material due to shelf-life expiry. Develop and implement inventory control processes.
- Regulatory Compliance: Ensure that all supply activities are compliant with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and local/international regulatory requirements. Ensure readiness for audits and inspections.
- Risk & Issue Management: Identify and proactively manage risks associated with clinical supply, including potential supply chain disruptions, regulatory hurdles, or quality issues. Develop mitigation strategies to ensure continuity of clinical trials.
- Budgeting & Cost Control: Manage clinical supply budgets, optimizing resources, controlling costs, and ensuring timely reporting on budget performance.
- Cross-functional Collaboration: Partner closely with clinical operations, quality assurance, regulatory affairs, and project management teams to ensure the clinical supply strategy continuously aligns with study requirements. .
- Process Optimization: Lead initiatives to streamline supply chain processes, enhance operational efficiencies, and implement best practices across the clinical supply chain.
- Executive Reporting: Provide regular updates to senior leadership on supply chain progress, risks, and opportunities. Contribute to strategic planning for the clinical trial supply organization.
Bring us your skills and energy, and shape your own career in a stimulating and open work environment. We are looking for highly motivated individuals who are ready to take on new challenges with enthusiasm and personal commitment. Working at Formycon means being part of a smart, innovative team with minimal hierarchy and opportunity to share your own ideas.
Have we sparked your interest? Then we look forward to receiving your application for employment through our online application portal. Please be sure to include all supporting documents, along with your earliest possible starting date and your salary expectations. We look forward to learning about you and the qualifications which you would bring to this position.
For any questions, please feel free to send us an email at recruiting@formycon.com.