Clinical Scientist

ROLE SUMMARY

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.

Work Location Assignment:Hybrid

This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply your Talent Advisor will share the local pay information with you during the first interview.

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 Inclusion

Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!

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Medical

Required Experience:

IC

Employment Type : Full-Time
Experience: years
Vacancy: 1