Key words: 

• You will act as the scientific leader for clinical studies and projects according to study planning, being responsible to develop and review documents in line with ICH/GCP, provide scientific/clinical input and expertise to the team and support the clinical operations.

Responsibilities:

• Contribute to the Development and Implementation of the Clinical Strategy in collaboration with the Development Team
• Contribute to the definition of key strategic clinical objectives
• Contribute to the elaboration Clinical Development Plan (CDP)
• Interact with KOLs to consolidate the CDP
• Develop Study synopsis
• Lead the development of clinical study documents (protocol and amendments, summaries, fact sheets and reports including drafting and review process until approval. Provide input to study documents with scientific content.
• Ensure that the study documentation is developed following ICH-GCP, with respect to subject assessment of eligibility, enrollment, clinical safety (adverse events, serious adverse events), data consistency, as well as the quality management system (QMS) applicable to the R&D environment
• Strong experience to analyse and interpret clinical data
• Participate to clinical operations activities requiring scientific input (internal and external meetings, investigator meetings, discussions with CRO/vendors/third parties). Contribute to the clinical assessment team activities (assessment plans, presentations, publications and literature searches), interact with other functions, external partners and 3rd parties. Collaborate with the clinical study, regulatory, quality and safety teams for the resolution of issues and crises
• Collaborate to write, review and update of SOPs/WKIs related to assessment activities. Work on the registration and publication of clinical studies/results and prepare the publication of results in peer-reviewed journals

Qualifications

• medical doctor degree or PhD required in science/health-related field or
• A minimum of 5 years of clinical research experience is a must, for MD background at least 5 years of drug development is desired
• Excellent understanding of the drug development process in order to effectively manage internal and external cross-functional interactions
• Excellent working knowledge of current ICH GCP guidelines, CFR, FDA and EMA, guidelines and regulations.
• Able to work independently and make appropriate strategic decisions to operationalize.
• Ability to interact with KOLs and to collect strategic input from various sources
• Open effective, and proactive written and oral communication, including effective presentation and communication skills
• Ability to manage multiple priorities, while maintaining attention to detail
• Experience operating effectively within a global matrixed environment, specifically in a healthcare/pharmaceutical start-up setting
• Strong influencing and leadership skills with proven ability to lead internal and external team members
• Pro-active and problem-solving attitude, acting with sense-of-urgency and applying an entrepreneurial mindset
• Self-motivation and able to work independently in a fast-paced, small company environment
• Strong work ethics
• Personal resilience, perseverance, energy and drive
• Fluent in spoken and written English, additional languages are an asset
• Candidate needs to hold a Swiss working permit or be an EU citizen eligible to work in Switzerland

What we offer:

• The opportunity to contribute to the next-generation strategy of a Biotech leader in the field of fibrosis
• A world-class learning environment and dedicated mentorship
• Fair compensation for your work and flexible working environment

Please submit your application at: career@alentis.ch