Job Description
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.
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.
- Education: Bachelor's degree in supply chain management, life sciences, or a related field. A Master's degree is preferred.
- Experience: At least 7-10 years of experience in clinical trial supply chain management, with at least 3 years in a senior role. Extensive experience in managing global clinical trials is essential.
- Knowledge: Strong understanding of GMP, GCP, and ICH guidelines, as well as regulatory requirements for clinical trial supplies across multiple regions (FDA, EMA, etc.).
- Leadership: Proven leadership abilities in a matrix organization.
- Technical Skills: Advanced proficiency with clinical supply chain management software, inventory control systems, and Microsoft Office Suite. Experience with ERP systems is a plus.
- Communication: Exceptional interpersonal, negotiation, and communication skills, with the ability to influence and collaborate with stakeholders at all levels. Business fluent English is essential, German an advantage.
- Problem-Solving: Strategic thinker with excellent problem-solving skills. Ability to anticipate issues and develop proactive solutions.
- Project Management: Strong project management skills, with the ability to manage multiple complex projects simultaneously and meet tight deadlines.
- Flexible working time
- Hybrid work
- 30 days paid vacation
- Formycon pension
- Group accident insurance
- Formycon card
- Continuing education offers
- Team spirit, great working atmosphere and much more!