clinical scientist 4961121

The Clinical Scientist (CS) provides leadership in conduct 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, oversight of core team activities and best practices to deliver both clinical and operational excellence within one or more programs in the Therapeutic Area (TA). 

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 Development (MED), 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 leading end to end numerous 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.

• Represents the line in program-wide functions and governance as needed. Contributes to discussions to ensure consistency across products/TA.

• May provide matrix oversight for other Clinical Scientists within the program.  Reviews work, develops staff, and provides ongoing feedback. 

• Using expert knowledge of epidemiologic/observational and specific aspects of trials, provides oversight of operational strategic partner involvement at a program or study level. Identifies issues in a timely manner, leads implementation of complex solutions, and/or escalates as appropriate.

• Influences management/senior staff decisions and is viewed as the Subject Matter Expert on CS decisions impacting a study/program.

• Provides CS leadership role in preparation of regulatory submissions, responses to regulatory queries, and in preparation for program regulatory inspections and audits.

• In collaboration with MED and Medical Affairs colleagues, present and discuss data at relevant team, governance, external consultants, KOLs and potentially regulatory meetings.

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BASIC QUALIFICATIONS

Training and Education

• BA/BS Degree in life sciences or health related field with 10+ years practical experience or MS/MBA with 8+ years, PharmD/PhD 6+ years and MD/DO with 3+ years.

Prior Experience and Capabilities

• Hands-on experience in study design, conduct and analysis.

• Experience working on global teams/studies

• Significant experience leading operational and/or strategic study teams

• Ability to work independently and collaborate with multiple functional groups within and outside (e.g., outside CROs/vendors) company

• Demonstrated advanced ability and level of experience with working across multiple studies for incorporation of consistent medical/scientific concepts in multiple protocols

• Extensive knowledge of the clinical research process and Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations

• Solid knowledge of therapeutic area

• Demonstrated independent authorship of study protocols and other study documents

• Working knowledge of statistics, data analysis, and data interpretation

• Experienced in managing external vendors for clinical and/or epidemiological study(ies)

Skills

• Has exceptional written and oral communication and cross-functional collaborative skills

• Ability to influence and collaborate with peers

• Strategic thinking and targeted problem-solving skills

• Ability to leverage, negotiate, and resolve conflicts to enhance team performance and delivery

PHYSICAL/MENTAL REQUIREMENTS

Nothing out of the ordinary

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

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