ROLE SUMMARY
The Clinical Scientist (CS) - Sr. Manager will support clinical epidemiology study execution for multiple studies for one or more vaccine programs. In collaboration with Scientific Affairs (SA) / Clinical Epidemiology, Biostatistics group and Clinical Affairs (CA) Operations, the CS is responsible for execution and project management of their studies which may vary and include both Pfizer-sponsored studies and externally-sponsored Research Collaborations. The CS position is a global position and may support projects in the US, Europe and Developed Markets. The CS works in a matrix organization and interacts with Epidemiologists, Biostatisticians, Clinical Operations, Global and Regional Medical/Scientific Affairs, Pfizer Research and Development clinical and laboratory groups, and external team members. Study responsibilities include core study document development (e.g., protocols, informed consent documents, case report forms, etc.), data review, oversight of study conduct activities with a focus on compliance, quality, safety, data integrity, and in alignment with company values. The CS, in partnership with Medical/Scientific Affairs, also supports the development and execution of the epidemiological plans and study strategies in support of the Clinical Development and Life Cycle plans. Data generated by epidemiological studies is critical evidence needed to support clinical development, to obtain optimum Vaccine Technical Committee recommendations, and to develop studies for post-licensure vaccine effectiveness regulatory commitments.
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ROLE RESPONSIBILITIES
The CS is responsible for supporting end-to-end study activities for multiple epidemiological studies across various SOPs (for each study):
- Protocol and study training - independently drafts study concepts/synopses, protocol and amendments of moderate complexity in collaboration with Scientific Affairs Lead, Biostatistician, and other relevant team members (e.g., VRD, external collaborators). Prepares and provides clinical protocol training materials to internal and external study team members. Ensures proper compliance and governance processes are followed in developing and approving study protocols. Drafts and/or reviews informed consent documents and supports the preparation of other clinical study documents as needed.
- Data collection, review and interpretation - provide clinical input on case report form development in accordance with clinical protocol requirements. Provide input on study data review plans and perform clinical data review in collaboration with Scientific Affairs Lead. Contribute to and participate in data interpretation and analyses discussions.
- Study oversight - in collaboration with Scientific Affairs Lead, and other operational study team members, provide clinical guidance and oversight during the execution of the study to ensure protocol compliance, issue resolution, patient safety, and data integrity. Maintain appropriate study documentation (e.g., meeting minutes, decision logs)
- Safety review and communication - depending on the nature of the study and its associated safety reporting requirements, conduct appropriate safety data review.
- Regulatory document, study report, and publication preparation and review - provide input on study-related regulatory documentation/correspondence. Provide clinical and operational content for clinical study reports and publications as appropriate. Lead efforts and responses for study audits (depending on study type).
- Epidemiologic study / program implementation - depending on the nature of the study (i.e., which SOP applies), may manage vendors (e.g., CRO, laboratory, supplies), develop and/or review study budgets, develop and maintain study timelines, track study deliverables, review protocol deviations and manage compliance issue follow-up and remediation
BASIC QUALIFICATIONS
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
- BA/BS Degree in life sciences or health related field with 7+ years practical experience or MS/MPH with 5+ years; PharmD/PHD with 2+ years
- Has experience planning and managing epidemiology studies
- Has experience participating in and leading operational study teams
- Has ability to work independently with moderate supervision
- Experience in research on infectious disease and/or vaccines
- Demonstrated ability and experience with integrating and summarizing medical / scientific concepts in study protocols and other clinical documents
- Has advanced knowledge of the clinical research process and Good Clinical Practices from previous employment experience in the clinical research field
- Has independently authored clinical protocols and other clinical study documents
- Has working knowledge of statistics, data analysis, and data interpretation
- Has experience in managing external vendors for clinical and/or epidemiological studies
- Fluent in English writing, reading, and speaking and has exceptional written and oral communication and cross-functional collaborative skills.
PREFERRED QUALIFICATIONS
- MS or PhD preferred
- Has experience in working in a global setting
- Is proficient in MS Word, Excel, and PowerPoint
- Prior infectious disease, microbiological or infection control experience
- Has worked in Industry
Last date to apply: November 4, 2024.
The annual base salary for this position ranges from $131,200.00 to $218,600.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 17.5% 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.
Medical