Clinical Scientist, Vaccines, Senior Manager
Pfizer
Scientist For Clinical Trials - Vaccines, Senior Manager
Pfizer
full-time
Posted on:
Origin: • 🇺🇸 United States • New York, Pennsylvania
Visit company websiteJob Level
Senior
About the role
- Provide clinical and scientific oversight and support for multiple, global Phase 1 - 4 clinical trials in support of the development strategy for programs within our Vaccines portfolio.\n
- Responsible for design, scientific oversight, data integrity and quality of the clinical trial(s) alongside the Lead Clinician.\n
- Author protocols, study level informed consent documents, and contribute to authoring site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents.\n
- Partner with other clinical colleagues, clinical operations and other functional lines for successful implementation and execution of the clinical trial(s).\n
- Lead clinical input for study setup and design, including data tools, analysis, and database setup.\n
- Contribute to the Statistical Analysis Plan and clinical data outputs.\n
- Review and query trial data in support of the clinical data review strategy and collection of quality data and review of emerging clinical data and trends, present and discuss relevant data to appropriate teams, and other internal/external stakeholders.\n
- In close partnership with medically qualified colleague(s), analyze the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s).\n
- Follow relevant SOPs and regulations, comply with applicable trainings, seek opportunities to further improve quality and efficiency of clinical procedures; lead or actively participate in portfolio and enterprise level workgroups aimed at optimizing PFE clinical development procedures; may be a subject matter expert or business process owner for a relevant SOP or procedure.\n
- Maintain current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
Requirements
- BA/BS Degree in a science or health-related discipline\n
- Strong clinical research background and Good Clinical Practices experience\n
- Working experience in the vaccines therapeutic area\n
- Experience integrating and summarizing medical/scientific concepts in protocols and documents\n
- Proven record of independently writing clinical protocols and study documents\n
- Experience participating in and informally leading an operational team\n
- Process improvement experience\n
- Working knowledge of statistics, data analysis, and data interpretation\n
- Exceptional written and oral communication and cross-functional collaborative skills\n
- Proficient in MS Word, Excel, and PowerPoint\n
- MS, PhD or Pharm D
