Scientist For Clinical Trials--Vaccines (Senior Manager)
Scientist For Clinical Trials--Vaccines (Senior Manager)
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Job Description
POSITION SUMMARY
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 RESPONSIBILIITIES
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 Degree in a science or health-related discipline
Strong clinical research background and Good Clinical Practices experience
Working experience in the vaccines therapeutic area
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 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 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 iscommitted to celebratingthisin all itsforms 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!
MedicalRequired Experience:
Senior Manager
Employment Type
Full-Time
