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Pfizer Inc. Director, Vaccines Clinical Research and Development in Pearl River, New York

ROLE SUMMARY
The clinician medical monitor is accountable for providing medical and
scientific expertise and oversight for Clinical Trials and serves as a
single point of accountability for design, execution, monitoring,
delivery and reporting of one or more clinical studies and to ensure
patient safety.
The clinician medical monitor may be required to design a development
strategy for multiple protocols designed to obtain worldwide approval
for a compound or group of compounds.
In addition to study level activities, the clinician medical monitor may
participate in standing committees, review compounds for potential
in-licensing, including performance of due diligence reviews, and
provide assistance to new business development on market opportunities
and the target product profile.

ROLE RESPONSIBILITIES

Accountable for safety across the study:
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.
Ensures development of and adherence to the Safety Surveillance Review
Plan (SSRP). Consistent with the SSRP, performs and documents regular
review of individual subject safety data, and performs review of
cumulative safety data with the safety risk lead. As appropriate, the
clinician medical monitor may delegate these responsibilities to the
study clinician scientist identified in the SSRP. The specific
components of safety data review are detailed in the appropriate SOPs
and the "Safety Data Review Guide - for Clinicians."
Monitor study safety issues and provide input to serious adverse events
(SAEs) reports. Provides appropriate medical context in terms of risk
factors, medical history and other important medical factors required to
put the SAE or AE into appropriate medical context required for
benefit-risk assessments.
Participates in the Safety Review Team to evaluate medical
benefits/risks to support targeted clinical indications.
Reviews literature as needed to respond to safety questions or those
posed by the Safety Review Team, Data Monitoring Committee (DMC) or
other individuals or bodies involved with the study.
Communicates safety information to sites across the study and provides
responses to questions on safety.
Protocol design and strategy:
Provide medical input during development and updates to the clinical
development plan.
Designs clinical studies to meet the stated objectives. Assures that
clinical trial objectives fit with the clinical program strategy.
Ensure that documents (protocol, Informed Consent Document \[ICD\],
etc.) meet regulatory requirements and company policy and has been
reviewed by IRB/IECs.
Provides medical input into country feasibility.
Support study team
Provides clinical input to protocol/study team for monitoring
guidelines, statistics analysis plans, ICDs, clinical review forms, data
edit checks, data quality planning, as needed (ultimately oversees work
of protocol/study team).
Contributes to contract research organization / vendor selection to
ensure study is conducted consistent with protocol requirements,
clinical plan expectations, and study timelines; this includes ensuring
medical/technical requirements for data integrity are applied.
Works with study team to ensure high quality of data e.g. appropriate
patient population, adequacy of clinical assessments as study is
ongoing.
Conducts medical review and interpretation of efficacy and safety data
from clinical trials; this may include delivery of top-line report in
collaboration with study statistician, and delivery of clinical study
report in collaboration with medical writer and accountable for overall
quality and timeliness of analysis and reporting.
Ensures the medical and scientific validity of study report, especially
conclusions regarding efficacy and safety. Responsible for disclosure of
appropriate safety and efficacy data and conclusions
(ClinicalTrials.gov, EudraCT, or Pfizer.com).
Provides protocol specific training to study team, investigators,
clinical research associate, and others.
Interacts with healthcare professionals at sites (leveraging the RMMs
when assigned) during the conduct of the study to enable quality,
compliance and patient safety at the trial, site and patient level.
Interacts with DMCs and steering committees as required.
Notify appropriate study team personnel of the need to inform
investigators of any changes in research activity and any significant
new adverse events.
Monitor investigator compliance with protocol and regulatory
requirements.
Support study team in issues resolution, study closeout, audit
responses, inspection readiness, etc.
Support the program team:
Authors clinical sections of regulatory documents (Investigator
Brochure, Annual Reports, Investigational New Drug sections, clinical
study report).
May co-author abstracts, posters, presentations and publications.
May contribute budget execution of protocols
Interact with regulatory authorities, key opinion leaders, and principal
investigators:
Supports Clinical Regulatory Authority interactions accountable for
providing responses.
Liaise with Key Opinion Leaders and Principal Investigators in countries
to build a Key Opinion Leaders /Principal Investigators network for new
trials

QUALIFICATIONS

BASIC QUALIFICATIONS
Medical degree (M.D./D.O. or equivalent).
Licensed by a health authority to prescribe medicines (independent of
supervision) for at least one year (post "intern/houseman" year), and
has utilized the license to prescribe medicines in a patient care
setting for an aggregate duration of at least one year.
Possesses the ability to critically evaluate medical/scientific
information.
Excellent written and oral communication.
Understands the design, development, and execution of clinical programs
and studies.
Capacity to adapt to a fast pace and changing environment.
Documented experience in the pharmaceutical industry related to clinical
research programs and registration activities.
Responsible for managing multiple studies
LI-PFE

PREFERRED QUALIFICATIONS
Documented work experience/knowledge of statistics.
Training and experience in infectious diseases and/or infection control
in the hospital setting is preferred.
Experience withinvestigational clinical trials is preferred

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.

PHYSICAL/MENTAL REQUIREMENTS
N/A

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Some travel may be required.
Relocation support available

Sunshine Act
Pfizer reports payments and other transfers of value to health care
providers as required by federal and state transparency laws and
implementing regulations. These laws and regulations require Pfizer to
provide government agencies with information such as a health care
provider's name, address and the type of payments or other value
received, generally for public disclosure. Subject to further legal
review and statutory or regulatory clarification, which Pfizer intends
to pursue, reimbursement of recruiting expenses for licensed physicians
may constitute a reportable transfer of value under the federal
transparency law commonly known as the Sunshine Act. Therefore, if you
are a licensed physician who incurs recruiting expenses as a result of
interviewing with Pfizer that we pay or reimburse, your name, address
and the amount of payments made currently will be reported to the
government. If you have questions regarding this matter, please do not
hesitate to contact your Talent Acquisition representative.

Medical

EEO & Employment Eligibility:

Pfizer is committed to equal opportunity in the terms and conditions of
employment for all employees and job applicants without regard to race,
color, religion, sex, sexual orientation, age, gender identity or gender
expression, national origin, disability or veteran status. Pfizer also
complies with all applicable national, state and local laws governing
nondiscrimination in employment as well as work authorization and
employment eligibility verification requirements of the Immigration and
Nationality Act and IRCA. Pfizer is an E-Verify employer.

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