Clinical Scientist–Vaccines (Senior Manager) Full-time

Clinical Scientist Role

You will 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.

Position Responsibilities

• Along with the Lead Clinician, responsible for the design, scientific oversight, data integrity and quality of the clinical trial(s).
• Author protocols, study level informed consent documents, and contribute to authoring of site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents.
• Partner with other clinical colleagues, clinical operations and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program.
• Lead clinical input for study setup and design, including data tools, analysis, and database setup. Contribute to the Statistical Analysis Plan and clinical data outputs.
• 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.
• 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).
• 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.
• Maintain current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.

Required Qualifications

• 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

Preferred Qualifications

• PhD/PharmD and 2+ years experience in a vaccines clinical scientist type role
• MA/MBA/MS and 5+ years clinical development experience 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.

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

Work Location Assignment: Hybrid