Careers

To further strengthen our organization ,we are looking for an experienced Clinical Operations Manager. This position is on a permanent basis. The successful candidate will work at the company on site (Zurich area).

Role and Responsibilities:

• Leading the implementation and management of clinical trials from start-up to close-out; including budgeting and timeline planning.

• Conducting clinical trials in accordance with GCP regulations and internal SOPs; ensuring inspection-readiness at all times.

• Anticipating potential risks within the clinical program, creating contingency plans and driving solution implementation.

• Establishing trial milestones and ensuring accurate tracking and reporting of trial metrics and timelines, alert in case of deviations, and propose mitigation plans.

• Providing operational input into protocol synopsis, trial protocol and all other trial related documents.

Requirements:

• University degree or equivalent in Life Sciences.

• Solid working knowledge of GCP, ICH guidelines, and relevant regulatory requirements.

• 4+ years’ experience working as a Clinical Operations Manager or in a similar role, including budget tracking and operational planning.

• Proven track record of successful independent management of Phase I to III clinical trials in the pharmaceutical industry or CRO in Europe, including: Coordination of investigator sites, clinical experts, and cross functional teams / Monitoring and oversight of service provider’s performance and deliverables / Operational fluency with EDC, IRT, eTMF, and other digital clinical trial systems.

• Experience with studies conducted in the United States is preferred.

• Experience working in Regulatory Affairs is a plus.

• Excellent interpersonal, verbal, and written communication skills and problem-solving capabilities.

• Ability to manage multiple tasks and timelines simultaneously and to work in a fast paced, dynamic environment.

• Fluent written and spoken English.

If you are interested in this position, please submit your application here.

To strengthen our Biomarker discovery and Bioanalytics team, we are looking for a highly motivated Research Associate with experience in in vitro assay development and validation. You will support our preclinical and clinical programs through critical analyses, such as drug quantification, immunogenicity assessments, and the development of innovative biomarker assays.

Roles and Responsibilities:

• Develop a broad range of bioanalytical assays using various platforms including medium to high sensitivity immunoassays (e.g. SIMOA, MSD, ELISA platforms).

• Develop immunohistochemical or biochemical assays in multiple matrices (blood, CSF, tissue).

• Perform preclinical PK, ADA and biomarker studies.

• Qualify established assays following regulated guidelines (GxP).

• Evaluate, interpret, and report results.

• SOPs and document writing, accurate work documentation.

• Support method transfers to internal and external collaborators.

• Implement robust laboratory processes.

Requirements:

• BSc or MSc in biology or biochemistry or a related discipline.

• Expertise in in-vitro assay development, ligand binding assays, troubleshooting, qualification and validation.

• A solid understanding of regulated environments (GxP) is a plus.

• Detail-oriented, focused on data quality.

• Good writing and communication skills.

• Ability to work independently and effectively on multiple parallel projects.

• A good knowledge of English is required.

If you are interested in this position, please submit your application here.