Lead the global clinical research program(s):
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Provide high level oversight of the direction and planning of global clinical programs including the preparation of Clinical Development Plans
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Oversee one or more Clinical Project Teams
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Identify program issues and develop sound strategic solutions with clinical teams to ensure their timely resolution
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Form ad hoc teams with appropriate representation to resolve various clinical/medical issues that develop during clinical development or lifecycle execution
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Provides updates to Senior Vaccines Research and Development Management of status of clinical programs
Oversee global clinical research program(s):
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Establish program priorities and drive key programs
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Collaborate with clinical lead to determine the scientific content of the Investigator meeting and determine the best method for training site personnel
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Oversee and participate in writing and/or review of key documents (e.g., briefing documents, manuscripts, submission documents)
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Assure quality of program through oversight of initial program activities, during implementation and monitoring of clinical trials, and during completion of final documents for publication and regulatory submission
Administer/Oversee global clinical research program(s):
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Oversee clinical lead and clinician medical monitor activities by identifying and tracking their deliverables from a program management perspective to ensure their timely completion
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Hiring, training, and monitoring of personnel performance. Coach, train, and/or mentor clinician medical monitors and clinician clinical scientists to optimize their performance
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Provide input into staffing and budgetary planning; departmental standard operating procedures (SOPs) and standard practice instructions, standardization activities; and project effort and prioritization analysis
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Define medical research resource requirements to support each study in the clinical program(s)
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Develop or oversee budget for a given product or entire therapeutic area as appropriate in conjunction with Finance
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Provide input into the insource/outsource approach for the program(s)
Represent the medical research and Vaccines Research and Development point of view to other line functions:
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Provide input into the publications strategy and critically review publications
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Provide input into the regulatory strategy and interact with Regulatory Affairs and regulatory agencies as appropriate
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Provide strategic scientific input to the global asset team
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Interface with various auditing groups regarding medical findings (i.e., clinical study report [CSR]) and provide guidance in responding to questions
Function As Global Medical Monitor
Accountable for safety across the study:
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Review serious adverse events (SAEs) and determine if a follow up action is needed
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Interact with Data Monitoring Committee (DMC) and other steering/review committees as required
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Answer safety questions and review the literature as needed to answer these questions or those posed by Safety Review Team, DMC, etc.
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Review Informed Consent Documents from sites and where there are deviations from approved Safety Review Team wording
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Safety communications to sites across the study
Provide program team(s) with medical expertise during key activities:
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Study closeout/inspection readiness
Interact with regulatory groups and internal auditing groups on a project level:
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Data Monitoring Committee Interaction
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High level accountability for providing a response to regulatory agency inspection observations and internal audits
Contribute to, review, and edit, CSRs:
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Approve patient narratives
Conduct decision point preparation for senior management.
Participate in (and/ or chair) the Vaccines Clinical Review Committee (VCRC).