Clinical Scientist - Senior Manager

The 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 the Clinical Affairs, Medical Leads, Regional and Scientific Affairs Physicians and/or Leads and will develop study strategies in support of the MDSCA Medical Plan and early epi in the VRU Clinical Development Plans. Studies include routine clinical trials, Research Collaborations, Low-interventional (CT45) and non-interventional studies across all 4 regions (Americas, AfME, EU, AP). 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 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.

1) PROTOCOL AND STUDY DESIGN

• Independently write/design protocol outlines, protocols, and amendments of moderate complexity in collaboration with the 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
  

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 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 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
  

3) STUDY MEDICAL OVERSIGHT

• Collaborates with the 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 SA Lead
  
• Consulted during vendor selection for specific medical 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 Scientific Affairs Lead
  

5) REGULATORY AND PUBLICATIONS

• 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
  

6) EPIDEMIOLOGICAL PROGRAM IMPLEMENTATION

• Along with the 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 Scientific Affairs Lead as primary 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) May provide mentoring support for other Clinical Scientists within the program.

8) Represents Vaccine Clinical Affairs

• 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.
  

9) Collaborate with Regional, Medical and Scientific Affairs Leads and other team members on development of Medical Plans and epidemiological components of the Clinical Development Plan for a program or multiple programs.

EDUCATION AND EXPERIENCE

• BA/BS Degree in life sciences or health related field with 5+ years practical experience or MS/MpH with 3+ years.
  

TECHNICAL SKILLS REQUIREMENTS.

• Has extensive knowledge ofthe 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 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
  
• 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.
  

Other Job Details:

• Last Date to Apply for Job: February 24, 2021
  
• Additional Location Information: 20-30% travel globally
  

Sunshine Act

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EEO & Employment Eligibility

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