Clinical Scientist, Director

ROLE SUMMARY

The Clinician, Clinical Scientist (CS) will provide leadership in clinical epidemiological 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 Evidence Generation projects in the US, Europe, Developed and Emerging 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 operating 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 which are pivotal to fulfil Pfizer’s regulatory commitments.

ROLE RESPONSIBILITIES

• The RWE Platform Vaccines and Antiviral 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 as applicable.  Contributes to discussions to ensure consistency across all programs.

• May provide matrix oversight for other RWE Platform 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 epidemiologic and Phase IV study planning activities including contributing to annual Operating Plan and Lifecycle Plan development.

• 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 and Medical/Scientific Lead, prepares strategy decisions, presents and discusses 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.

BASIC QUALIFICATIONS

• BA/BSc Degree in life sciences or health related field with 10+ years practical experience or MSc/MPH with 8+ years or PhD with 6+ years.

• Has strong hands-on experience in epidemiological / observational 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.<