Senior Clinical Scientist

Job content

To support our Clinical team, we are currently looking for a Senior Clinical Scientist (100% m/f).

You hold a degree in Life Science and minimum of five years’ experience in Clinical Project Management roles with strong regulatory and project management skills. Demonstrated working experience in an industrial, biomedical research setting would be ideal.

As a Senior Clinical Scientist, your responsibilities will include:

• Design regulatory strategy and clinical development plans together with Clinical and regulatory director
• Managing and preparing ethical and regulatory submissions
• Anticipating potential issues and risks in the clinical trials and creating contingency plans and implementing solutions
• Supporting the Clinical Director in designing clinical trials
• Developing the Statistical Analysis plan for the ongoing studies in collaboration with the CRO statisticians. Acting as main point of contact for CRO statisticians
• Identifying, coordinating, and supporting the development of clinical assays with external partners and/or clinical sites
• Analyzing, interpreting, and presenting of clinical data internal and externally.
• Conducting data checks, data query and database integrity assignments in collaboration with the clinical trial team
• Supporting the preparation and/or review of clinical study documentation
• Work according to ICH GCP (E6-R2), local applicable regulations and company’s specific SOPs
• Developing and maintaining high quality study related documentation, including but not limited to protocol, study plans and clinical study report
• Fulfill regulatory requirements including registering and maintaining trial information into clinical databases
• Tracking and managing operational aspects of projects including budgeting, trial master file and risk management
• Identifying, selecting, managing and overseeing external vendors, such as Contract Research Organizations (CROs), clinical sites, central laboratories etc. to ensure performance and deliverables
• Planning and conducting investigator meetings, training sessions and KOL meetings, as required
• Authoring, revising and/or updating SOPs, Work Instructions and additional relevant documents
• Supporting general activities of the clinical department and representing clinical in cross-functional teams and to the management or key stakeholders as needed

Qualifications

You are an efficient and enthusiastic multi-cultural team player with:

• Previous experience in regulatory affairs, documentation to FDA, EMA, etc
• Experience in planning and managing late stage clinical trials
• Good statistic background with focus on clinical trials
• Hands-on experience in managing operational aspects of clinical trials and developing all study-related documents
• Excellent planning and communication skills
• In-depth knowledge of ICH-GCP and experience in risk assessment and development of mitigation plans
• Ability to work successfully in a biotechnology culture where a premium is placed on delivering science-based results in an entrepreneurial, fast moving and a sometimes resource constrained environment
• Good verbal and written communication skills in English

The working place is in Schlieren near Zürich, easily accessible by public transportation. If you meet the requirements of this exciting position and want to work in a friendly, highly motivated and dynamic team, we are interested in hearing from you.

The file you upload must include a motivation letter, CV, diplomas and references in one pdf.

Due to visa regulations, only applicants eligible to a Swiss work permit can be considered for this position.