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Responsibilities:
Review and 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 and updates to the
clinical development plan.
● Provide medical input during clinical protocol development and Informed
Consent Document (ICD).
● Medical review of country feedback during protocol feasibility to ensure
understanding and mitigation of any feedback which may impact future protocol
compliance, risks to subject safety or data integrity. (e.g. understanding of
local standard of care and 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 for all medical issues during risk
assessment and mitigation planning to enable quality, compliance and patient
safety at the trial, site and patient level.
● Provide medical input to the study team for study 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/vendor selection to ensure study is conducted consistent with protocol
requirements and/or clinical development plan expectations.
● Site interactions
● Develop and maintain peer to peer relationships with healthcare
professionals at clinical trial sites (in collaboration with RCSLs when
assigned to a study).
● Participate and lead site staff training or retraining when medical input is
required (e.g. Investigator meetings, 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 and patient level.
● Act as a point of contact for medical questions at site level and
responsible for clarifications to site personnel to interpretation of protocol
and knowledge of medical practice, leveraging the RMM organization if assigned
to the study
● Other external interactions ● Participate in medical interactions with
opinion leaders, regulatory agencies, payers in development of clinical plan
and 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/or clinical program interactions
● Develop, participate and lead study team training or retraining when medical
input is required (e.g. protocol specific training, training in response to
other medical issues that may arise).
● Conduct medical review and interpretation of efficacy and safety data during
study conduct. Examples include but are not limited to; Regular review of
individual subject safety data and review of cumulative safety data with the
safety risk lead (when assigned to a clinical program) consistent with the
Safety Review Plan.
Oversight and as necessary remediation of risks identified during risk
assessment and mitigation planning which require oversight by a medically
qualified individual.
● Provide project team with medical advice for other 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 for early identification of potential
safety issues.
● Liaise regularly with RMMs when assigned to the study to ensure knowledge
sharing and global consistency in medical oversight activities.
● Medical review of efficacy and safety data in support of development of
top-line report and clinical study report in collaboration with the study team
in particular with regards the overall conclusions with regards safety and
efficacy and assessment of benefit risk. ● Provide medical advice and oversight
to the study team or clinical program in response to audits or inspections,
including providing medical advice and support as needed to audit/inspection
responses (e.g. site visits if specific medical expertise is required to
further investigate or remediate findings). ● May co-author abstracts, posters,
presentation sand publications.
Technical/Behavioral Competencies:
● Proven ability to get results in a matrixed management environment.
● Knowledgeable of the commercial and environmental issues that drive clinical
programs.
● Regulatory awareness – proven track record of proactive management of
regulatory issues related to protocols and programs, including comprehensive
experience of interactions with regulatory authorities.
Education:
M.D. or equivalent medical qualification (refer to Global Clinical Leadership
Team definition of ‘medically qualified individual’)
Pfizer is an equal opportunity employer and complies with all applicable equal
employment opportunity legislation in each jurisdiction in which it operates.


Pfizer is an equal opportunity employer and complies with all applicable equal
employment opportunity legislation in each jurisdiction in which it operates.
Medical