Wundmanager providing professional care for chronic and difficult - to - heal wounds in a specialized home care setting. Joining a dynamic team with a focus on improving patient quality of life.
About the role
- Senior Manager in Clinical Sciences leading clinical studies development and execution for a biotech company. Collaborating across teams to ensure study integrity and compliance
Responsibilities
- Leads in the development, evaluation, planning and execution of clinical studies
- Ensures integrity and interpretation of study data of a clinical development program
- Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings
- Participates in collaborative activities with other departments
- Develops/maintains understanding of therapeutic disease area(s) and drug candidate including underlying disease biology
- Applies basic scientific expertise to support initiation and execution of clinical research and development studies for early and/or late stage assets
- Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
- Collaborates with internal functions and external vendors to promote clinical study integrity
Requirements
- Bachelor’s Degree
- Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc)
- ≥ 8 years of pharmaceutical clinical drug development experience
- Proven knowledge of the drug development process
- Good Clinical Practice
- study design
- clinical research methodology & medical writing skills
- Knowledge of clinical development process
- regulatory requirements and ICH/GCP guidelines
- Proven track in clinical trial process improvements
- Experience in one or more of the following therapeutic areas - cardiovascular, renal, metabolic disease - preferred
Benefits
- health and wellness programs
- fitness centers
- equity awards
- annual bonuses
- paid time off
Job title
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