Clinical Scientist - Senior Manager

Collegeville, Pennsylvania
February 26 2021
Position Type
Full Time
Organization Type
Job Type

The Emerging Markets (EM) Clinician, Clinical Scientist (CS) will provide clinical study and project leadership for multiple, global, Phase 4 clinical studies for a region or asset epidemiological research program. They are responsible for working collaboratively with Emerging Markets Medical Affairs (Vaccines Medical and Scientific Affairs Lead, Regional Medical and Scientific Affairs Lead, Country/Cluster Medical Affairs Lead), Clinical Affairs, Global/MDSCA colleagues, and (as needed) VRU colleagues, and will develop study strategies in support of the EM Medical Plan. Epidemiology projects supporting early epi in the VRU Clinical Development Plan are included. Studies include routine clinical trials, Research Collaborations, Low-interventional (CT45) and non-interventional studies globally. The EM CS will lead via a matrix organization a Core Team for each study. EM CS leadership 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 EM CS will also support operationally and clinically the development and execution of the Epidemiology Plan (part of the Medical and CDP) from pre-POC through life cycle at the program level. Data generated by epidemiological studies is critical evidence needed to obtain optimum Vaccine Technical Recommendations at the country level including National Immunization Programs.


  • Independently write/design protocol outlines, protocols, and amendments of moderate complexity in collaboration with the Vaccines EM Medical and Scientific Affairs Lead, primarily with support from Medical, DevOps, Statisticians, and other relevant groups including PHI, VRD, external investigators.
  • Ensures protocols are robustly vetted, include all appropriate line input and are compliant.
  • Create medical training materials for site management
  • Specific medical/protocol training for site facing roles including monitors, DevOPs and CRO staff
  • Site medical/protocol training for use during site initiation visits
  • Safety and protocol training at the investigator meeting
  • Assist in preparation and participate in consultant and key opinion leader meetings
  • Complete clinical sections of the Site Reference Manual/Epidemiological Surveillance Manuals
  • Provide input on country feasibility as delegated by the Clinical Program Lead and/or Lead Clinician
  • Lead strategy discussions of moderate complexity and actively participates in consultant meetings
  • Create informed consent form templates, and review site prepared ICFs
  • Support the preparation of other clinical documents as required

  • 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 EM Vaccines Medical and Scientific Affairs Lead 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 coordinating with EM Vaccines Medical and Scientific Affairs Lead for study level review as delegated
  • Study analysis and decision point preparation including interim analysis, stopping rules, DMC and DSMB management
  • Interprets data and is able to identify issues of moderate/difficult complexity
  • Independently prepares efficient plan for medical review of data and moderates data review independently

  • Collaborates with the EM Vaccines Medical and Scientific Affairs Lead to provide epidemiological, medical/scientific guidance during the execution of the study
  • Provide medical perspective in consultation with the DevOps during the development of the monitoring plan
  • Answer specific site management protocol questions as needed
  • Medical issue resolution (study wide, escalated regional/site) with EM Medical Lead and SA Lead
  • Consulted during vendor selection for specific medical 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 EM Vaccines Medical and Scientific Affairs Lead

  • Provide in-depth epidemiological/scientific/medical input, review and edit 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 Medical Lead and publications team to determine publication strategies
  • Provides significant contribution to content of abstracts, posters and manuscripts
  • Lead efforts and responses for any Audits

  • Along with the EM Vaccines Medical and Scientific Affairs Lead is accountable for the Epidemiological/Medical/Safety/Scientific Design and Execution of a Study, with oversight of CRO activities if relevant.
  • Leads the Study Core Team with the EM Vaccines Medical and Scientific Affairs Lead as partner. Drives Core Team in execution of studies of all types
  • For CRC CT44 studies assumes multiple roles - CS, Project Manager, DevOps, Clinician to execute studies with the sponsor investigator. Drives study forward, is the captain of the ship for CT44.
  • For Non- interventional studies (CT24) lead all clinical aspects related to development, execution and analysis of the study as relevant. Manage vendors and lead Medical/Scientific study team.
  • Provide operational and scientific support to ad-hoc Medical/Scientific Leads epidemiology projects outside of Pfizer SOP. For example, fee for service work with an external vendor.
  • Provide asset level support for study tracking and reporting for the global Vaccines organization.
  • 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 DevOps and with regard to medical/safety concerns, ensures study level issues are resolved.
  • Collaborate with Scientific Affairs Lead and DevOPs to arrive at major site level decisions based on input from the team
  • Drive budget creation with DevOPs
  • Coordinates with DevOps to maintain study timelines.
  • Along with the Scientific Affairs Lead and the Team, develops study level enrollment plan
  • Along with the DevOps and other study team members, participates in training of Study Management Staff and monitoring staff.
  • Ensure standard processes, tools, and procedures used consistently and globally
  • Provide input into the preparation of study level training materials in collaboration with CPM 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) Represents EM in the MDSCA forums and enterprise wide initiatives for process improvement

8) Collaborate with Medical Affairs (Vaccines Medical and Scientific Affairs Lead, Regional Medical and Scientific Affairs Lead, Country/Cluster Medical Affairs Lead), Clinical Affairs, Global/MDSCA colleagues, and (as needed) VRU colleagues, and other team members on development of Medical Plans and epidemiological components of the Clinical Development Plan for a program or multiple programs.

  • BS/MS degree with 7-10 years experience
  • 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 or infectious disease therapeutic area
  • Has strong experience planning and managing epidemiology studies including patient based burden of disease.
  • 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
  • Has experience in managing external vendors for clinical studies and/or epidemiological analysis
  • Applies knowledge of internal/external business challenges to facilitate process improvements
  • Has ability to work independently with moderate supervision
  • 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
  • Fluent in English writing, reading, and speaking and has exceptional written and oral communication and cross-functional collaborative skills.

  • 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

  • Position requires travel (30-40%) both domestic and international. International travel to emerging markets countries. Weekend and evening work likely to be required based on project needs as needed but the exception rather than rule.

Other Job Details:
  • Last Date to Apply for Job: March 11 2021
  • Eligible for Employee Referral Bonus

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