Lead cross - functional submission teams in the delivery of major marketing submissions for innovative medicines. Collaborate with regulatory and project management teams to ensure operational success and quality.
CS
Onsite Senior Director, Global Clinical Program Lead – Cardiovascular, Renal
Posted 8 hours ago
About the role
- Senior Director Clinical Program Lead overseeing clinical strategy and execution for cardiovascular medicine development in a global biotherapeutics leader. Managing clinical development teams and ensuring compliance with scientific standards.
Responsibilities
- You will be accountable for the design and execution of the clinical strategy to support the development of a medicine, aligned with the Project Strategy Document (PSD) and the Target Product Profile (TPP).
- You are also accountable for the strategic leadership of the Clinical Development Team (CDT) in a matrix environment and is responsible for: the timely development and execution of the Clinical Development Plan (CDP).
- Managing the day-to-day operations of the CDT including but not limited to meeting coordination and documentation, decision making, and stakeholder management.
- Ensuring that the program is conducted in alignment with CSL Behring processes and abiding by GCP and ICH regulations.
- This position is accountable for the clinical & scientific oversight of the assigned program(s) and: ensures high quality clinical & scientific standards are met during all aspects of the program providing clinical oversight and expertise during development of clinical studies.
Requirements
- MD - Board Certified (or non-USA equivalent) in relevant field is preferred (Cardiology, Neurology, Intensive Care Medicine, Internal Medicine)
- Clinical development industry experience with a working knowledge of pharmaceutical and regulatory development processes is essential.
- 5+ years of relevant clinical development experience is expected including experience of study data review/evaluation in a pharmaceutical or clinical study environment.
Benefits
- For more information on CSL benefits visit How CSL Supports Your Well-being | CSL
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