Position: Clinical Trial Supply Manager (m/f/d)
About Us:
We are an innovative biotechnology company with a global presence, specializing in developing advanced immunotherapies for cancer and autoimmune diseases. Our operations span multiple countries, and we are driven by the goal of delivering groundbreaking treatment options to patients worldwide.
Location Options:
- Based in Berlin, Germany (flexible onsite presence: 75-100%)
- Remote work with occasional travel to the Berlin office (approx. 10%)
Overview of the Role:
As part of our growing team, you will play a pivotal role in managing clinical trial supply logistics for our leading immunotherapy candidate, currently undergoing late-stage global clinical trials. Reporting to the Senior Director of Manufacturing, you will be responsible for ensuring the continuous and compliant supply of investigational products and related materials to clinical sites worldwide.
Key Responsibilities:
- Develop study-specific supply strategies, including RFP generation, vendor selection, and contract negotiations.
- Oversee the global distribution network for investigational products, comparators, and ancillary supplies.
- Manage importation processes, ensuring timely and compliant delivery to regional depots and trial sites.
- Monitor inventory levels, expiration dates, and resupply strategies to ensure continuity.
- Forecast clinical trial supply needs based on study protocols and patient projections.
- Design labeling and packaging strategies tailored to diverse regulatory requirements.
- Identify potential supply risks and develop mitigation plans in collaboration with stakeholders.
- Coordinate shipment tracking and ensure proper handling of investigational products.
- Collaborate with cross-functional teams to establish and maintain IWRS or IRT systems for clinical trials.
- Manage budgets related to packaging, labeling, storage, and distribution, ensuring cost efficiency.
- Maintain strong partnerships with vendors and ensure compliance with regulatory guidelines (GMP, GDP, GCP).
What We're Looking For:
Essential Qualifications:
- Advanced degree in life sciences, engineering, or a related field.
- 5+ years of experience in the pharmaceutical or biotechnology industry, with 3+ years in clinical trial supply chain management.
- Expertise in managing global clinical trials, ideally with biologics.
- Strong project management skills and the ability to work effectively in cross-functional teams.
- Proficiency in English and familiarity with Microsoft Office tools.
Desirable Skills:
- Experience in vendor management and negotiation.
- In-depth knowledge of clinical trial supply chain services, including procurement and distribution.
- Familiarity with the drug development process and regulatory guidelines.
- Previous leadership experience is a plus.
What We Offer:
- A chance to contribute to the development of innovative therapies in an exciting and rapidly evolving field.
- Work with a passionate and international team of experts.
- Competitive compensation and benefits package.
