Provides scientific and clinical development input for the safe, efficient and timely 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 and development of trial related documents and the scientific oversight of clinical trials
Facilitates a team to define and deliver the clinical strategy within projects and programs
Defines scientific strategy for various program components
Can lead development of Clinical Development Program
Authors clinical study documents and assists with development/critical review of submission documents
Contributes to authorship and review of manuscripts, conference abstracts, etc.
Collaboratively develops the clinical development strategy with project teams, providing input, guidance and mentorship for project teams
Contributes 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

Bachelor's degree or equivalent in Science, Allied Health or Engineering
Preferred: An advanced degree (MSc, PhD) in Science, Allied Health or Engineering, PMP Certification, Masters of Business Administration (MBA) or equivalent
8+ years experience in the biotechnology or pharmaceutical industry (or where relevant a biomedical research organization)
5+ years in managing projects
In-depth knowledge in the drug development and manufacturing processes for pharmaceuticals (CMC, non-clinical, clinical, Regulatory Affairs)

Principal Scientist

Key skills