The Clinician, Clinical Scientist (CS) will provide leadership in clinical epidemiology study execution ensuring consistency of approach, conduct, result reporting and oversight of core team activities within one or more vaccine asset programs. In collaboration with Scientific Affairs (SA) Biostatistics group and Clinical Affairs (CA) Operations, the CS is responsible for execution and project management of their studies. The CS will be responsible for numerous epidemiological studies run either as Pfizer-sponsored or as Research Collaborations. The CS is a global position and may support all types of MDSCA projects in the US, Europe and Developed Markets. As lead of the Study Core Team the CS will lead via a matrix organization Epidemiology, Biostats, Clinical Operations, Medical/Scientific Affairs, Regional, Pfizer laboratory assay group, and external team members. The CS also has a strategic role in partnership with Medical/Scientific Affairs to develop 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 (planning for Phase 3 efficacy trial, including a series of studies to determine incidence and risk groups to inform Phase 3 methodology and identify trial sites), to obtain optimum Vaccine Technical Committee recommendations, schedules, and public payer option, and to develop studies for post-licensure vaccine effectiveness regulatory commitments.
This particular position will support a Post Marketing Commitment study in the US for the pneumococcal franchise.ROLE RESPONSIBILITIES
- The CS is responsible for leading multiple end to end epidemiological studies across various SOPs (for each study): 1) protocol, study design and training, 2) data review and interpretation, 3) study and/or program scientific and integrity oversight, 4) safety review and communication, 5) regulatory document, study report, and publication preparation and review, and 6) clinical study implementation oversight, with a critical focus on consistency (within regions and globally, including common protocols, CRFs, and databases), quality, data integrity, safety, and alignment with company values.
- Represents Clinical Affairs line in program-wide functions on Clinical Project Team, Medical Sub Committee, Clinical Study Teams, Asset Team, Program Teams, and Regulatory Strategy teams. Co-lead Epidemiology Sub Team meetings. Contributes to discussions to ensure consistency across all programs.
- May provide matrix oversight for other Clinical Scientists within the program. Reviews work, develops staff, , and provides ongoing feedback. Responsible for short- and long-term resource planning, priority setting, and filling of resource and skill gaps to address the needs of the program(s).
- Using expert knowledge of epidemiologic and vaccine clinical 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 working with Clinical Affairs Lead, Medical/Scientific Affairs Lead and Partner representatives.
- Influences management/senior management decisions and is viewed as the Subject Matter Expert on CS decisions impacting a program and potentially the Medical/Scientific Affairs groups.
- Collaborates with Medical/Scientific Leads and other team members on development of Epidemiology Plan and provides input on asset strategy and Lifecycle Development Plan for epidemiological studies.
- 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 the Clinical Affairs Lead andMedical/Scientific Lead, prepare strategy decisions, present and discuss data at relevant team, governance, external consultants, KOL and potentially regulatory meetings.
- Represents Vaccine Clinical Affairs and may take the lead on company-wide, global process improvement initiatives, and champions process enhancements and solutions for complex issues. Leads change for Vaccine Clinical Affairs on new company initiatives
- BA/BS Degree in life sciences or health related field with 7+ years practical experience or MS/MPH/MD with 4+ years.
- Has industry experience as a Clinical Scientist or simlar
- Has strong hands on experience in epidemiology study design, conduct and analysis.
- Has significant experience leading operational and/or strategic study teams
- Has significant experience working independently and collaborating with multiple functional groups within and outside the business line
- Experience in research on infectious disease and/or vaccines is desirable.
- Has demonstrated an advanced ability and level of experience with working across multiple studies for incorporation of consistent medical/scientific concepts in multiple protocols and ensuring they meet strategic program objectives
- Has advanced knowledge of the clinical research process and Good Clinical Practices from previous employment experience in the clinical research field
- Has solid knowledge of vaccine therapeutic area
- 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. German speaking desirable.
- 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
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.PHYSICAL/MENTAL REQUIREMENTS
Nothing out of the ordinaryNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Position requires travel (20-30%) both domestic and international. Weekend and evening work likely to be required based on project needs as needed but the exception rather than rule.Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.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.