Posted on: November 21, 2022
- An infectious disease physician with experience in antiviral
- 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
RESPONSIBILITIESAccountable 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
- 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
- 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
- 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
- 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
- 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
- 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 investigatorcompliance with protocol and regulatory
- Support study team in issues resolution, study closeout, audit
responses, inspection readiness, etc.Supports 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
- May contribute budget execution of protocolsInteract with
regulatory authorities, key opinion leaders, and principal
- 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 trialsBASIC 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
- Excellent written an 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 at least 2+
- Responsible for managing multiple studiesPREFERRED
- 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
preferredCandidate 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.NON-STANDARD WORK SCHEDULE, TRAVEL OR
ENVIRONMENT REQUIREMENTSPfizer is a global organization and there
will be a requirement to travel and work outside of their local
business hoursRelocation support availableWork Location
Assignment:FlexibleFor roles based in New York City: The annual
base salary for this position ranges from $191,800.00 to
$319,700.00. In addition, this position offers an annual bonus with
a target of 25.0% of the base salary and eligibility to participate
in our share based long term incentive program. Benefits offered
include a retirement savings plan, paid vacation, holiday and
personal days, paid caregiver/parental and medical leave, and
health benefits to include medical, prescription drug, dental and
vision coverage in accordance with the terms and conditions of the
applicable plans.Relocation assistance may be available based on
business needs and/or eligibility.Pfizer requires all U.S. new
hires to be fully vaccinated for COVID-19 prior to the first date
of employment. As required by applicable law, Pfizer will consider
requests for Reasonable Accommodations.Sunshine ActPfizer 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.EEO & Employment
EligibilityPfizer 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
Keywords: Pfizer, Hartford , Clinical Director, Executive , Hartford, Connecticut
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