Responsibilities:
- You will be responsible for scientific input to clinical development strategies and therapeutic areas.
- Provide scientific and clinical development input for the safe and efficient execution of assigned programs, ensuring the highest quality and full compliance of all outputs.
- Will contribute to the development of the scientific strategy of the clinical development plan, the design of trial related documents and the scientific oversight of clinical trials.
- You will facilitate a team to define and deliver the clinical strategy within programs.
- Define scientific strategy for multiple program components.
- You will lead the development of Clinical Development Program.
- Author clinical study documents and assists with development/critical review of submission documents.
- Contribute to authorship and review of manuscripts and conference abstracts.
- Collaboratively develop the clinical development strategy with project teams, providing input, guidance and mentorship for project teams.
- Contribute to the scientific analysis and interpretation of clinical data and the writing of clinical study reports, internal and external scientific meeting presentations and peer-reviewed publications, and all regulatory submission documents.
- Will foster close collaboration with other departments, defining and improving interfaces to other departments.
Qualifications:
- Bachelor's degree or equivalent in Science, Allied Health or Engineering.
- 8+ years experience in the biotechnology or pharmaceutical industry (or where relevant a biomedical research organization).
- 5+ years managing projects.
- In-depth knowledge in the drug development and manufacturing processes for pharmaceuticals (CMC, non-clinical, clinical, Regulatory Affairs).
The role is based in Glattbrugg, Switzerland and requires an onsite presence of 3 days per week.