Senior Director of Clinical Development
4 weeks ago
About the Role:
The Senior Director of Clinical Development will provide statistical leadership for clinical development and life-cycle management strategies for assigned projects. This includes clinical trials, patient safety, and global medical affairs. The ideal candidate will work in partnership with experts in multiple disciplines to advance medicines to our patients.
Responsibilities:
- Provide expertise/lead regulatory submission and product life-cycle management strategy planning and implementation for assigned projects.
- Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs.
- Independently develop protocols and statistical analysis plans (or product safety analysis plans/integrated summary of safety analysis plans/analysis plans for GMA evidence generation).
- Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management.
- Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies for assigned projects.
Requirements:
- MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or a highly related field.
- High degree of technical competence and excellent communication skills, both oral and written.
- Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others.
- Able to manage project timeline and quality of deliverables.
- Able to build strong relationship with peers and cross-functional partners to achieve higher performance.
- Have strong leadership skills and experience in working/managing cross-cultural or oversea teams.
About AbbVie:
AbbVie is a global biopharmaceutical company that discovers and delivers innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.
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