Clinical Development Lead, Liver Cancer/Fibrosis (6336)

The Life Science Career Network

CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.

Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world’s largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally.

For their office in the area of Zug/Lucerne, we are currently looking for a:

Clinical Development Lead, Liver Cancer/Fibrosis

on an unlimited contract .

In this role, you will be responsible for planning and implementing clinical development activities for novel medical value diagnostic solutions in the areas of Chronic Liver Diseases, with a primary focus on Liver fibrosis.

Main Responsibilities:

• Acting as subject matter expert for Liver Oncology.
• Designing the clinical studies and evidence generation strategies for internal and external stakeholders in the assigned indication area.
• Reviewing study results, protocols and reports generation to support new product development.
• Working cross-functionally with colleagues from Business, Medical Affairs, Clinical Operations, Regulatory Affairs, Biometrics, Development, Quality, and other functions to ensure appropriate implementation of clinical development strategies.
• Maintaining clinical, regulatory, and scientific expertise as it relates to IVD product development and regulatory documentation.
• Leading medical and scientific input and preparation of regulatory submissions as well as responses to reviewers from regulatory agencies.

Qualifications and Experience:

• Relevant Swiss working/residency permit or Swiss/EU-Citizenship required.
• At least a Medical degree or advanced degree in Life Sciences (PhD, PharmD or equivalent degree).
• Minimum 3-5 years relevant expertise in the Healthcare Industry and/or academic institutions.
• Ideally having experience in IVD or Medical Device development in all stages of global studies, development of study protocol design, report writing and leading matrixed teams.
• Strong experience in liver Indication (Fibrosis and/or Liver cancer);
• Ability to lead clinical development studies and programs and good knowledge in applicable standards and regulations, especially in global studies in the US and negotiation with the FDA.
• Knowing the agile culture and exhibits an agile mindset.

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the ‚apply now‘ button, or write an email to us.

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