Associate Director Clinical Portfolio Execution
4 days ago
CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. Our company is committed to delivering medicines that improve their lives.
We are seeking an experienced Associate Director Clinical Portfolio Execution to join our team. This role will be responsible for developing the operational strategy for clinical studies and programs, and overseeing the end-to-end study delivery of all operational activities and budget management relating to assigned clinical studies.
Key Responsibilities- Operational Strategy Development
- Lead the development of operational strategies for clinical studies and programs
- Coordinate with functional area representatives on all study-related activities, ensuring timelines, budget, and quality are maintained
- Study Management
- Project manage clinical studies from protocol development to Clinical Study Report (CSR) completion and Trial Master File (TMF) archiving
- Develop study timelines and budget
- Ensure regulatory compliance and GCP compliance
- Team Leadership
- Lead a team of study managers and coordinators
- Provide guidance and support to team members
- Vendor Management
- Lead vendor selection and management/oversight, including issue escalation
- Regulatory Compliance
- Ensure internal and external study team members are trained on the protocol and study processes
- Develop proactive risk mitigation strategy and corrective action plan to address study issues in collaboration with the study team
- Reporting and Communication
- Report main study performance information, including study start-up metrics, enrollment, and data collection
- Be a primary contact both internally and externally for anything study-related
- Education
- Bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical-related area
- Experience
- 10+ years of clinical research experience within the pharmaceutical industry
- Knowledge of the drug development process and specifically, each step within the clinical trial process
- Experience overseeing large global clinical trials (pharmaceutical or CRO)
- Budget forecasting and management experience
- Knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process
- Medical, Dental, and Vision Benefits
- 401K Plan
- Paid Time Off
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