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 in Vaccines portfolio
- Design, scientific oversight, data integrity and quality of the clinical trial(s) alongside Lead Clinician
- Author protocols, informed consent documents, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents
- Partner with clinical operations and other functional lines for successful implementation and execution of trials
- 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; analyze emerging clinical data and trends; present data to stakeholders
- In partnership with medically qualified colleagues, analyze emerging safety profile and inform clinical and safety colleagues
- Follow SOPs and regulations; participate in process improvement workgroups and possibly serve as SME or process owner
- Maintain current scientific and clinical knowledge in therapeutic/disease area of assignment
Requirements
- BA/BS/BSN in a health or related science discipline and 7+ years of experience in clinical development including 2 years of experience in a clinical scientist type role with a proven track record executing vaccine development programs to completion or targeted milestone
- 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
- PhD/PharmD and 2+ years experience in a vaccines clinical scientist type role (preferred)
- MA/MBA/MS and 5+ years clinical development experience including 2 years of experience in a clinical scientist type role (preferred)
- Candidate demonstrates leadership, ability to influence and collaborate, develop and coach others (preferred)