Salary
💰 $135,100 - $225,100 per year
About the role
- Provide clinical and scientific oversight and support for multiple, global Phase 1-4 clinical trials for Vaccines portfolio
- Along with Lead Clinician, responsible for design, scientific oversight, data integrity and quality of clinical trials
- Author protocols, informed consent documents, contribute to site training materials, clinical study reports, regulatory responses
- Partner with clinical operations and cross-functional teams for trial implementation and execution
- Lead clinical input for study setup and design, including data tools, analysis, and database setup
- Contribute to Statistical Analysis Plan and clinical data outputs
- Review and query trial data, review emerging clinical data and trends, present data to stakeholders
- Analyze emerging safety profile in partnership with medically qualified colleagues
- Follow SOPs and regulations, participate in process improvement and enterprise workgroups
- Maintain current scientific and clinical knowledge in assigned therapeutic areas
Requirements
- BA/BS/BSN in a health or related science discipline and 7+ years of experience in clinical development including 2 years in a clinical scientist type role with proven track record executing vaccine development programs
- Strong clinical research background and Good Clinical Practices experience
- Vaccines development experience
- Experience integrating and summarizing medical/scientific concepts in protocols and documents
- Proven record of independently writing clinical protocols and study documents
- Experience participating in and informally leading an operational team
- Process improvement experience
- Working knowledge of statistics, data analysis, and data interpretation
- Exceptional written and oral communication and cross-functional collaborative skills
- Proficient in MS Word, Excel, and PowerPoint
- Preferred: PhD/PharmD and 2+ years in vaccines clinical scientist role OR MA/MBA/MS and 5+ years clinical development experience including 2 years in clinical scientist role
- Candidate demonstrates leadership experience including influencing, coaching, and overseeing colleagues