CSL Behring is a global leader in developing and delivering life-saving medicines for people with rare and serious diseases. We are committed to making a difference in the lives of patients around the world.
We are looking for a Director, Early Development Safety Lead to join our team. In this role, you will be responsible for providing safety expertise and oversight for our early-stage clinical development programs. You will work closely with cross-functional teams to ensure the safety of our patients and the public.
Responsibilities:
- Provide strategic input into pre-clinical and early clinical development, regulatory, and issue management activities.
- Develop risk mitigation strategies for early clinical development assets.
- Ensure that safety considerations are reflected in clinical trial documents.
- Analyze aggregate safety data and review emerging safety data from pre-clinical and early clinical studies.
- Serve as the safety representative in research and early clinical development teams.
- Identify and implement necessary risk management initiatives.
- Comply with legal requirements and company standards of pharmacovigilance.
Qualifications:
- MD (Medical Doctor) degree, international MD equivalent, or advanced life sciences degree.
- 5+ years of pharmaceutical/biotechnology industry experience, preferably in a safety role.
- 3+ years of experience working with assets in early clinical development (phase 1 and phase 2), including FIH studies.
- Experience analyzing toxicology and pharmacology data.
- Understanding of the product development process and relevant scientific principles.
- Experience with qualitative benefit-risk assessments, signal and risk management, and pharmacovigilance concepts.
Benefits:
- Competitive salary and benefits package.
- The opportunity to make a real difference in the lives of patients.
- A collaborative and supportive work environment.
- The chance to work with cutting-edge technology and innovative therapies.
To Apply:
Submit your CV by November 30, 2024.
Location:
- Parkville, Victoria, Australia
- Marburg, Germany
- Bern, Switzerland
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation,1 age, marital status, veteran status, or disability status.2
We encourage you to make your well-being a priority. It’s important, and so are you.
Do work that matters at CSL Behring!
