Clinical Science Lead - Schlieren, Schweiz - LimmaTech Biologics AG
vor 1 Woche
Beschreibung
LimmaTech Biologics AG is a Swiss clinical stage biopharmaceutical company.We are advancing our proprietary vaccine pipeline to halt the increasing threat of global infections due to emerging antimicrobial resistance (AMR) and sexually transmitted diseases.
Working at LimmaTech is a unique chance to be part of the development of life saving vaccines.To support our clinical team, we are currently looking for a:
Clinical science lead %)
You hold a degree in Life Science (MD, PhD, Pharm D, M. Sc, or other scientific field preferred) and have minimum of five years' experience in clinical science, clinical research, or equivalent with strong scientific and analytical skills. Demonstrated working experience in an industrial, biomedical research setting would be ideal.
As a Clinical science lead, your responsibilities will include:
- Providing scientific expertise to design and deliver clinical studies and programs
- Proposing, discussing, and implementing clinical development plans and regulatory strategies to achieve desired outcomes in close collaboration with the clinical director
- Managing and supervising clinical team members to execute clinical trial activities
- Proactively assessing risks and suggesting solutions for the allocated programs
- Ensuring the timely delivery of milestones in terms of quality, budget and timelines
- Closely collaborating with the clinical operations team to ensure timely submissions and deliverables
- Acting as a key point of contact for interaction with key stakeholders, including advisory boards, funders, and competent authorities
- Managing resources efficiently and effectively
- Representing the company in external congresses and meetings
- Authoring and reviewing clinical study reports/abstracts/publications
- Previous experience in regulatory affairs, documentation to FDA, EMA, etc.
- Good statistics background with focus on clinical trials
- Handson experience in managing operational aspects of clinical trials and developing all studyrelated documents
- Excellent planning and communication skills
- Indepth knowledge of ICH-GCP and experience in risk assessment and development of mitigation plans
- Ability to work successfully in a biotechnology culture in an entrepreneurial, fastpaced environment, where sciencebased outcomes matter
- Good verbal and written communication skills in English
Please note that due to visa regulations, only applicants eligible to work in Switzerland can be considered for this position.
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