Responsibilities:
Review oversight of the adequacy of other clinical assessments (as
appropriate).
● Clinical development plan, clinical protocol development, study planning and
initiation ● Provide medical input during development updates to the
clinical development plan.
● Provide medical input during clinical protocol development Informed
Consent Document (ICD).
● Medical review of country feedback during protocol feasibility to ensure
understanding mitigation of any feedback which may impact future protocol
compliance, risks to subject safety data integrity. (e.g. understanding of
local standard of care impact on ability to execute clinical protocol).
This is performed in collaboration with the Regional Clinical Site Leads
(RCSLs) if they are assigned to the clinical trial.
● Provide study team with medical advice fall medical issues during risk
assessment mitigation planning to enable quality, compliance patient
safety at the trial, site patient level.
● Provide medical input to the study team fstudy specific control plans
(e.g. study monitoring plans, ICDs, data edit checks, safety review plan and,
if RCSLs are assigned to the study, the RMM Medical Oversight Plan) ● Ensure
medical requirements are accurately defined (e.g. lab specifications) during
CRO/vendselection to ensure study is conducted consistent with protocol
requirements and/clinical development plan expectations.
● Site interactions
● Develop maintain peer to peer relationships with healthcare
professionals at clinical trial sites (in collaboration with RCSLs when
assigned to a study).
● Participate lead site staff training retraining when medical input is
required (e.g. Investigatmeetings, study site initiation visits, protocol
specific training, training in response to other medical issues that may arise).
● Interact with healthcare professionals at sites (leveraging the RCSLs when
assigned) during the conduct of the study to enable quality, compliance and
patient safety at the trial, site patient level.
● Act as a point of contact fmedical questions at site level and
responsible fclarifications to site personnel to interpretation of protocol
knowledge of medical practice, leveraging the RMMganization if assigned
to the study
● Other external interactions ● Participate in medical interactions with
opinion leaders, regulatory agencies, payers in development of clinical plan
protocols.
● Interact(as applicable)with data monitoring committees, end point
adjudication committees, steering committees when medical questions/problems
are surfaced which require feedback input from the study team.
● Study team and/clinical program interactions
● Develop, participate lead study team training retraining when medical
input is required (e.g. protocol specific training, training in response to
other medical issues that may arise).
● Conduct medical review interpretation of efficacy safety data during
study conduct. Examples include but are not limited to; Regular review of
individual subject safety data review of cumulative safety data with the
safety risk lead (when assigned to a clinical program) consistent with the
Safety Review Plan.
Oversight as necessary remediation of risks identified during risk
assessment mitigation planning which require oversight by a medically
qualified individual.
● Provide project team with medical advice fother program related
activities which are not related to a specific clinical study/s e.g.
interpretation of preclinical data.
● Review on regular basis SAE reports fearly identification of potential
safety issues.
● Liaise regularly with RMMs when assigned to the study to ensure knowledge
sharing global consistency in medical oversight activities.
● Medical review of efficacy safety data in support of development of
top-line report clinical study report in collaboration with the study team
in particular with regards the overall conclusions with regards safety and
efficacy assessment of benefit risk. ● Provide medical advice oversight
to the study team clinical program in response to audits inspections,
including providing medical advice support as needed to audit/inspection
responses (e.g. site visits if specific medical expertise is required to
further investigate remediate findings). ● May co-authabstracts, posters,
presentation spublications.
Technical/Behavioral Competencies:
● Proven ability to get results in a matrixed management environment.
● Knowledgeable of the commercial environmental issues that drive clinical
programs.
● Regulatory awareness – proven track record of proactive management of
regulatory issues related to protocols programs, including comprehensive
experience of interactions with regulatory authorities.
Education:
M.D. equivalent medical qualification (refer to Global Clinical Leadership
Team definition of ‘medically qualified individual’)
Pfizer is an equal opportunity employer complies with all applicable equal
employment opportunity legislation in each jurisdiction in which it operates.
Pfizer is an equal opportunity employer complies with all applicable equal
employment opportunity legislation in each jurisdiction in which it operates.
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