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 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 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 MEG and Medical Affairs colleagues, 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 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/studiesSignificant experience leading operational and/or strategic study teamsAbility to work independently and collaborate with multiple functional groups within and outside (e.g., outside CROs/vendors) companyDemonstrated advanced ability and level of experience with working across multiple studies for incorporation of consistent medical/scientific concepts in multiple protocolsExtensive knowledge of the clinical research process and Good Clinical Practices (GCPs), monitoring, clinical and regulatory operationsSolid knowledge of therapeutic areaDemonstrated 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

Has exceptional written and oral communication and cross-functional collaborative skillsAbility to influence and collaborate with peersStrategic thinking and targeted problem-solving skillsAbility to leverage, negotiate, and resolve conflicts to enhance team performance and delivery

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.

The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations.  These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure.  Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act.  Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government.  If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.  Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Pfizer is an E-Verify employer.  This position requires permanent work authorization in the United States.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

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