Jobs at Debiopharm

Provide GCP oversight for clinical development: vendor qualification, KQI monitoring and trending, risk management, audit and inspection readiness, CAPA management, and training compliance to protect trial integrity and patient safety.

Lead design and execution of a risk-based global Audit & CAPA framework. Own master audit planning, manage external auditors, perform targeted audits, support inspection readiness, drive CAPA development, monitor metrics and continuous improvement across GxP activities.

Design, build, automate and operate cloud-native data platforms (Azure/AWS) for clinical analytics in a GxP environment. Develop frontend/backend tooling, maintain IaC and CI/CD, administer SAS Viya and Medidata, ensure security/compliance, and provide L2 support and platform owner responsibilities.

Lead and perform pharmacometrics modeling and simulation (POPPK, PK/PD, ER, disease progression, trial simulation) across non-clinical to clinical stages, support model-informed drug development strategy, prepare regulatory documentation, communicate results cross-functionally, contribute to scientific publications and external forums, and support licensing activities.

Manage and evaluate safety risks for oncology (and antibiotics) products in development. Provide medical input for regulatory and clinical documents, perform medical review of safety cases, lead signal detection efforts, oversee outsourced PV vendor activities, join study teams, and participate in safety meetings and task forces.

The Principal Clinical Pharmacologist will develop clinical pharmacology strategies for oncology and infectious disease projects, manage studies, and ensure regulatory compliance while collaborating with cross-functional teams.

Support early oncology clinical development by applying statistical methods for dose optimization, adaptive designs, and probability-of-success assessments. Collaborate with cross-functional clinical trial teams to plan and execute analyses and deliver statistical insights. Optionally develop interactive Shiny apps for dose escalation design and monitoring.

Support development and regulatory strategy for small molecules, biologics, and radiopharmaceuticals from first-in-human through registration. Manage submissions (IND/CTA, orphan, designation requests), vendor CROs, review regulatory documents, represent RA on cross-functional teams, maintain regulatory intelligence, and contribute to SOPs ensuring compliance.

Lead the Biostatistics and Data Management team, providing statistical guidance for clinical trials, ensuring compliance with regulatory standards, and driving innovation in statistical models.

As a Senior Clinical Data Manager, you will ensure data quality and timelines across clinical studies, manage data activities, and oversee compliance with regulations. You will lead teams and collaborate within a matrix environment.

The Senior Manager of Statistical Programming will lead a team in statistical programming, drive digitalization strategy, and ensure quality deliverables for clinical projects while collaborating across various functions.