ROLE SUMMARY: The Clinical Scientist (CS) will provide of observational study execution including epidemiological, non-interventional, pragmatic and low-interventional studies and research collaborations to ensure consistency of approach, conduct, monitoring, analysis, reporting, and oversight of core team activities within one or more asset programs in the Therapeutic Area (TA).  This position is within the vaccines team however it may also support other TAs for local China studies.

In collaboration with cross functional colleagues, the CS is responsible for execution and project management of their studies as well as oversight of studies executed by CSs supporting the product.  The CS collaborates with other Pfizer groups and oversees vendors to execute the studies.  The CS is responsible for numerous observational and epidemiological studies run as Pfizer-sponsored and/or as non-Pfizer sponsored Research Collaborations. 

The CS has a significant role in partnership with Medical Evidence Generation (MEG), Medical Affairs, Statistics, Clinical Data Sciences, Statistical Data Sciences & Analytics, and external team members, where applicable, and other team members on development of operational plans and provides input on tactical implementation of studies to support the asset strategies in line with Pfizer SOPs.  As co-lead of the Study Core Team, the CS leads via a matrix organization to execute studies.

ROLE RESPONSIBILITIES :

Responsible for supporting complex or leading low complexity studies across various SOPs, including tasks related to: 1) protocol and protocol specific training, 2) vendor management, 3) study level planning and oversight, 4) data review, 5) regulatory document, study report and publication preparation and review, and 6) overall study execution with a critical focus on consistency, quality, data integrity, safety, and alignment with company processes.Works in a global environment on studies across all regions including International, Emerging Markets and China.May represent line in program-wide functions and governance as needed. Contributes to discussions to ensure consistency across products/TA.Using knowledge of epidemiologic/observational and specific aspects of trials, provides support of operational strategic partner involvement at a program or study level. Identifies issues in a timely manner, leads implementation of solutions, and/or escalates as appropriate.Provides operational input on tactical implementation of studies.Provides CS leadership role in preparation of regulatory submissions and in preparation for program regulatory inspections and audits.In collaboration with MEG and Medical Affairs colleagues, may present and discuss data at relevant team, governance, external consultants, KOLs and potentially regulatory meetings.Contribute/champion R&D initiatives, process improvement initiatives, and/or solutions for complex issues.

BASIC QUALIFICATIONS

Training and Education

BA/BS Degree in life sciences or health related field with 5+ years practical experience or MS/MBA with 3+ years, PharmD/PhD 2 years, MD/DO with 1 year

Prior Experience and Capabilities

Industry experience in the Clinical Scientist or similar capacity.Experience working on multinational teams/studiesHands-on experience in epidemiology study design, conduct and analysis.Experience in or leading study teamsExperience working independently and collaborating with multiple functional groups within and outside the business lineDemonstrated an ability working across multiple studies for incorporation of consistent medical/scientific concepts in multiple protocolsStrong knowledge of the clinical research process and Good Clinical Practices (GCPs), monitoring, clinical and regulatory operationsDemonstrated independent authorship of study protocols and other study documentsWorking knowledge of statistics, data analysis, and data interpretationExperienced in managing external vendors for clinical and/or epidemiological study(ies)

Skills

Fluent in English writing, reading, and speaking and has exceptional written and oral communication and cross-functional collaborative skills.

PREFERRED QUALIFICATIONS

Has experience in working in a global settingIs proficient in MS Word, Excel, and PowerPointPrior therapeutic area experience

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Position may require up to 10% travel both domestic and international.  Weekend and evening work likely to be required based on project needs as needed but the exception rather than rule.

OTHER INFORMATION

Eligible for candidate referral bonus

 
Work Location Assignment: Hybrid

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical

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