Why Patients Need You
Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best-in-class medicines to patients around the world. ROLE SUMMARY
As a Senior Manager, Clinical Scientist
you will provide medical and scientific study and project support for multiple, global, Phase 1-4 vaccine clinical studies in a clinical program. In this role, you will be responsible for working collaboratively with the Clinical Program Lead and Lead Study Clinician and will develop study strategies in support of the clinical plans. ROLE RESPONSIBILITIES
This position 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.
You may be assigned to lead implementation of program level activities identified by the Lead Clinical Scientist and Clinical Lead as needed.
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
- 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, ensures study 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
- PhD or Pharm D and 8+ years of experience in vaccine therapeutic areas
- Has extensive knowledge of the clinical research process and Good Clinical Practices from previous employment experience in the clinical research field
- 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 Suite
Work location: On premise
Relocation support available
#LI-PFE 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.