About Debiopharm
Debiopharm is a privately-owned Swiss biopharmaceutical company dedicated to research in oncology and infectious diseases with the aim of improving patient outcomes and quality of life.
We develop innovative therapies through our unique "development only" business model, serving as a bridge between disruptive discovery products and patient access in international markets.
Our team at Debiopharm is committed to working on cutting-edge medicines for patients, driving innovation, impacting lives, and growing together.
Job Title: Biosample Manager
We are seeking an experienced professional to oversee the end-to-end management of biological samples in clinical trials, ensuring compliance with ethical, regulatory, and analytical standards.
This role involves collaborating with cross-functional teams to optimize biosample workflows, guaranteeing seamless operations from feasibility to long-term storage, and preclinical studies for repository.
Your Key Responsibilities:
* Design and implement biosample handling strategies for clinical trials, aligning with study protocols, regulatory requirements, and SOPs.
* Oversee Central Laboratories selection, qualification, and management, ensuring compliance with ICH GCP/GLP/IVDR and country-specific regulations.
* Ensure proper biosample collection, storage, logistics, and analysis, addressing deviations and implementing corrective actions.
* Lead the development of biosample-related trial documents, including Biosample Management Plans, Central Laboratory Manuals, and Data Transfer Specifications.
* Oversee Central Laboratory sample kits preparation and delivery to clinical sites, clinical sample shipments to specialty labs, maintaining chain-of-custody integrity.
* Manage clinical biosample and preclinical specimens retention and destruction in compliance with patient consent, study protocols, and regulatory guidelines.
* Support audits and inspections by preparing documentation, addressing findings, and ensuring biosample processes meet compliance standards.
* Act as a subject matter expert, driving innovation, process improvements, and training initiatives in biosample management.
Requirements
* Degree in Life Sciences or Healthcare with 5+ years of experience in clinical biosample management (end-to-end) at a sponsor.
* Strong expertise in sample logistics, central lab operations, and global regulatory frameworks.
* Understanding of ethical and legal requirements for handling human and non-clinical biospecimens.
* Demonstrated knowledge of ICH GCP/GLP/IVDR and country-specific accreditations/certifications for Central Laboratories.
* Understanding of regulatory requirements for handling nonclinical biospecimens.
* Proficiency in stakeholder collaboration, problem-solving, and regulatory compliance.
* Excellent organizational, communication, and time management skills.
* Excellent communication in English; French is an asset.
* International, highly dynamic environment with a long-term vision.
* Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry.
* Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry.
* Participation in a company where innovation, people, and entrepreneurship are the fundamental keys to success.
* Proud to be an Equal-Pay certified; we ensure offering to all our employees the same opportunities.