ROLE SUMMARY

The Senior Manager, Clinical Scientist (CS) will provide medical and scientific study and project support for multiple, global, Phase 1-4 vaccine clinical studies in a clinical program. They are responsible for working collaboratively with the Clinical Program Lead and Lead Study Clinician and will develop study strategies in support of the clinical plans. The CS support includes multiple tasks within the categories of 1) protocol and study design, strategy, 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, quality, data integrity, safety, and alignment with company values. The CS may be assigned to lead implementation of program level activities identified by the Lead Clinical Scientist and Clinical Lead as needed.

ROLE RESPONSIBILITIES

1) PROTOCOL AND STUDY DESIGN

• Create protocol training materials for site management
• Provide specific medical/protocol training for site facing roles including monitors and Study Managers
• Provide site medical/protocol training for use during site initiation visits
• Provide protocol training at the investigator meeting
• Assist in preparation for and participate in consultant and key opinion leader meetings
• Complete clinical sections of the Site Reference Manual
• Provide input on country feasibility as delegated by the Clinical Program Lead and/or Lead Clinician
• Independently write/design protocol outlines, protocols, and amendments of moderate complexity in collaboration with the Lead Clinician, Clinical Study Team Leads (CSTLs), Statisticians, and other relevant groups.
• Lead strategy discussions of moderate complexity
• Create informed consent form templates, and review site prepared ICFs
• Support the preparation of other clinical documents as required

2) DATA REVIEW AND INTERPRETATION

• Lead clinical input for and participate in study set up and design including data collection tools, data analysis, and database set-up
• Proactively coordinate with the Lead Clinician to assure understanding and agreement on deliverables throughout the process
• Provide input for the design of the Statistical Analysis Plan (SAP) and the clinical data output
• Responsible for review of patient level data across a study and for coordinating with Lead Clinician for study level review as delegated
• Lead or participate in study analysis and decision point preparation including interim analysis, stopping rules, DMC and DSMB management
• Interpret data and identify issues of moderate/difficult complexity in the data
• Independently prepares efficient plan for medical review of data and moderates data review independently

3) STUDY MEDICAL OVERSIGHT

• Collaborates with the Lead Clinician to provide medical/scientific guidance during the execution of the study
• Provides medical perspective in consultation with the CSTL during the development of the monitoring plan
• Answers specific site management protocol questions as needed
• Assists in medical issue resolution (study wide, escalated regional/site)
• Provides input during vendor selection for specific medical/protocol issues

4) SAFETY

• Track and reconcile SAEs across a study
• Report SAEs during Safety Review Team meetings
• Ensure timely communication of safety issues to sites
• Review and approval of patient narratives as delegated by the Lead Clinician

5) REGULATORY AND PUBLICATIONS

• Provide in-depth scientific/medical input, review and editing of clinical study reports (CSR).
• Provide full review of content and integrates information from literature and other sources as appropriate.
• Support and contribute to various sections of regulatory filings (Pediatric Investigational Plan ,IB, IND/NDA Annual Reports, and PSURs and Regulatory authority responses)
• Participate with the Clinical Program Lead and publications team to determine publication strategies
• Prepares audit responses as delegated by the Lead Clinician
• Participates in inspection readiness activities

6) CLINICAL PROGRAM IMPLEMENTATION

Along with the Lead Clinician is accountable for the Medical/Safety/Scientific Design and Execution of a Study.

• Ensure regulatory compliance and GCP adherence at the study level with regard to medical/scientific issues
• Initiate and coordinate corrective action for major medical/safety/scientific study level issues
• Along with CSTL and with regard to medical/safety concerns, ensuresstudy level issues are resolved.
• Collaborate with Lead Clinician and CSTL to arrive at major site level decisions based on input from the team
• Provide input during budget creation to Clinical Program Lead and Lead Clinician
• Coordinates with CSTL to maintain study timelines.
• Along with the CSTL and in agreement with the Clinical Program Lead/Lead Clinician and the Team, develops study level enrollment plan
• Along with the CSTL and other study team members, participates in training of Study Management Staff and monitoring staff.
• In collaboration with the CSTL and study team, ensures the clinical trial material requirements of the study are met.
• Ensure standard processes, tools, and procedures used consistently and globally
• Participates in developing training strategy for study with the study team members.
• Provide input into the preparation of  study level training materials in collaboration with CSTL and team members

Provide input into the monitoring plan for study

• Provide scientific and medical /technical support to ensure that monitoring plan addresses unique vaccine-specific activities supporting the endpoints of the trial
• Ensure execution of the global study management plan from a medical/safety/scientific perspective

7) May provide mentoring or line management support for other Clinical Scientists within the program.

8) Represents Vaccine Clinical Research and may take the lead on company-wide, global process improvement initiatives, and champion’s process enhancements and solutions for complex issues.  Leads change for Vaccine Clinical Research on new company initiatives.

9) May collaborate with Clinical Program Lead and other team members on development of program strategy and Clinical Development Plan for a program or multiple programs.

QUALIFICATIONS

BA/BS Degree in science or health-related field

MS, PhD or Pharm D preferred

• Has extensive knowledge of  the clinical research process and Good Clinical Practices from previous employment experience in the clinical research field
• Has working knowledge of vaccine therapeutic area
• Has demonstrated ability and level of experience with integrating and summarizing medical/scientific concepts in protocols and other clinical documents
• Has independently authored clinical protocols and other clinical study documents
• Has experience with participating in and informally leading an operational team
• Applies knowledge of internal/external business challenges to facilitate process improvements
• Has ability to work independently
• Has working knowledge of statistics, data analysis, and data interpretation
• Has exceptional written and oral communication and cross-functional collaborative skills
• Is proficient in MS Word, Excel, and PowerPoint

 
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.
Work Location Assignment: Flexible

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.

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