Director of Solution Advisory driving enterprise solutions for customers. Collaborating with sales teams to create impactful customer engagements across EMEA.
About the role
- Associate Director leading medical safety and risk strategies in early development at CSL Behring. Focused on patient safety and cross-functional collaboration in clinical trials.
Responsibilities
- Develop and implement risk mitigation strategies for early development assets (e.g., FIH/Phase 1 studies), ensuring endorsement by CSL Safety Governance
- Review and interpret emerging safety data from preclinical and early clinical studies; contribute to aggregate safety data analysis and key safety documents (DSURs, risk management plans)
- Support the setup and evaluation of preclinical data packages, identify new risks, and determine needs for supplementary data
- Respond promptly and concisely to regulatory agency safety requests
- Ensure risk mitigations are reflected in clinical trial documents (protocols, investigator brochures, informed consent forms)
- Provide guidance on safety issues and facilitate internal/external safety reviews (e.g., DMCs)
- Represent GSPV in cross-functional teams and chair safety management teams as needed.
Requirements
- PHD degree , or medical degree ( Doctors) with exposure to basic research work
- Minimum 5 years in pharmaceutical/biotechnology industry, preferably in a safety (MD) or research role (PhD)
- At least 3 years working with early clinical development assets leading to FIH or Phase 1-2 studies
- Subject matter knowledge in non-clinical toxicology, pharmacology, and manufacturing aspects relevant to safety
- Ability to develop a risk management framework through identification of potential risks, likelihood/uncertainty, and impact assessment
- Ability to perform qualitative therapeutic benefit-risk assessments with guidance
- Strong communication skills with the ability to synthesize complex concepts, seek feedback, and tailor messages for effective communication
- Exhibit leadership skills like independent thinking, cross-functional influence, conflict management, and adaptability to diverse situations and cultures.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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