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).