Responsibility

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 safetyat 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. 3.

Other external interactions

• Participate in medical interactions with opinion leaders, regulatoryagencies, payers in development of clinical plan and protocols.
• Interact(as applicable) with data monitoring committees, endpoint adjudication committees, steeringcommittees whenmedical 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 mayarise).
• Conduct medical review and interpretation of efficacyand safetydata during study conduct. Examples include but are not limited to; o 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 SafetyReview Plan. Review and oversight of the adequacy of other clinical assessments (as appropriate). Oversight and as necessary remediation of risks identified during risk assessment and mitigation planning which require oversight bya 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 consistencyin medical oversight activities.
• Medical review of efficacyand safetydata 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 safetyand 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 orremediate findings).
• Mayco-author abstracts, posters, presentations and publications.

Qualification

Education

• M.D. or equivalent medical qualification (refer to Global Clinical Leadership Team definition of ‘medically qualified individual’)

Experience

• Previous experience providing medical advice in a clinical research setting, including in academia, as an investigator, at a pharmaceutical company or CRO.
• 1 year of post internship experience in medical care of patients.
• Proven track record of being a successful medical monitor at the study level or program level.
• Has demonstrated knowledge of designing and delivering clinical program(s), to produce both timely and good quality data, including knowledge (and appropriate use) of innovative clinical trial principles and methodologies (e.g. Enhanced Clinical Trial Design (ECTD)/ Enhanced Quantitative Drug Development(EQDD), etc.).
• CVM background preferred

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