POSITION SUMMARY
You will provide clinical and scientific oversight and support for multiple, global Phase 1 - 4 clinical studies in support of the development strategy for programs within the Vaccines portfolio.
POSITION RESPONSIBILITIES
Maintains current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
Along with the Lead Clinician, is responsible for the design, scientific oversight, data integrity and quality of the clinical study.
Authors protocols, study level informed consent documents, and contributes to authoring of site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents.
Partners with other clinical colleagues, clinical operations and other functional lines for the successful implementation and execution of the clinical studies within the assigned program.
Leads clinical input for study setup and design, including data tools, analysis, and database setup. Contributes to the Statistical Analysis Plan and clinical data outputs.
Reviews and queries study data in support of the clinical data review strategy and collection of quality data and review of emerging clinical data and trends, presents and discusses relevant data to appropriate teams, and other internal/external stakeholders.
In close partnership with medically qualified colleague(s), analyzes 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).
Follows relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings, seeks opportunities to further improve quality and efficiency of clinical procedures; leads or actively participates 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.
REQUIRED QUALIFICATIONS
BA/BS Degree in a science or health-related discipline
A strong clinical research background and Good Clinical Practices experience
Working experience of vaccines therapeutic area
Ability to integrate and summarize 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
Has 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 QUALIFICATION
MS, PhD or Pharm D
Work Location Assignment:Hybrid
Purpose
Breakthroughs that change patients' lives ... At Pfizer we are apatient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self.Lets start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
DisAbility Confident
We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!
Medical
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