Salary
💰 $169,700 - $282,900 per year
About the role
- Provide clinical and scientific program support for a global clinical sciences team on a program
- Responsible for clinical sciences project management support on a program level and/or responsible for studies with a high degree of complexity
- Develop clinical development plans and study strategies in support of the plans
- Design, scientific oversight, data integrity and quality of clinical studies within the assigned program
- Author or oversee authoring of protocols, informed consent documents, clinical study reports, regulatory responses, and other clinical and regulatory documents
- Partner with clinical operations and other functions for successful implementation and execution of clinical studies
- Set clinical data review strategy and lead clinical sciences team in collection and review of emerging clinical data and trends
- Analyze emerging safety profile in partnership with medically qualified colleagues and keep colleagues informed
- Follow SOPs and regulations, lead or participate in process improvement workgroups, may be subject matter expert or SOP owner
- May supervise, mentor, and/or develop others
Requirements
- BA/BS Degree in a science or health-related discipline and a minimum of 10 years of experience in a similar role in industry/CRO
- Advanced knowledge of the clinical research process and Good Clinical Practices from previous employment experience
- Extensive experience in the vaccines therapeutic area
- Proven record of independently writing clinical protocols and study documents
- Working knowledge of statistics, data analysis, and data interpretation
- Process improvement experience
- Exceptional written and oral communication and cross-functional collaborative skills
- Proficient in MS Word, Excel, and PowerPoint
- Significant experience leading operational and/or strategic teams
- Preferred: Relevant PhD or PharmD and a minimum of 5 years of experience in a similar role in industry/CRO, OR MS and a minimum of 7 years of experience in a similar role in industry/CRO