Associate Director, Medical Monitor
Posted on: February 25, 2021
United States - Pennsylvania - Collegeville United States - New
York - Pearl River United Kingdom - Hurley ROLE SUMMARY
- The clinician medical monitor may contribute towards providing
medical and scientific expertise and oversight for Clinical
- 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.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
- 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
- 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
- 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
- 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
- Contributes towards the medical input during protocol
development and updates to the clinical development plan.
- Work closely with other medical monitors to ensure that
documents (protocol, Informed Consent Document [ICD], etc.) meet
regulatory requirements and company policy and has been reviewed by
- Provides medical input into country feasibility.Support study
- With supervision of medical monitor (director/Sr director)
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.
- 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.
- Contributes to medical review and interpretation of efficacy
and safety data from clinical trials; this includes 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.
- Provides protocol specific training to study team,
investigators, clinical research associate, and others.
- Interacts with healthcare professionals at sites 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.
- Notifies 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
- Support study team in issues resolution, study closeout, audit
responses, inspection readiness, etc.Supports the program team:
- Under supervision (director/Sr director) authors clinical
sections of regulatory documents (Investigator Brochure, Annual
Reports, Investigational New Drug sections, clinical study
- May co-author abstracts, posters, presentations and
- May contribute budget execution of protocols.Interact with
regulatory authorities, key opinion leaders, and principal
- May support 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.BASIC QUALIFICATIONS 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
- 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
- Medical degree (M.D./D.O. or equivalent).
- Documented work experience/knowledge of statistics
- Training and experience in infectious diseases and/or infection
control in the hospital setting is preferred.
- Experience with investigational clinical trials is
- No pharmaceutical industry experience required.Other Job
- Eligible for Relocation Package: YES
- Eligible for Employee Referral Bonus: YES#LI-PFE 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. 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.
Medical#LI-PFE Posted 16 Days Ago Full time 4804223 About Us Pfizer
careers are like no other. In our culture of individual ownership,
we believe in our ability to improve future healthcare, and
potential to transform millions of lives. We're looking for new
talent to join our global community, to unearth new innovative
therapies that make the world a healthier place.
Keywords: Pfizer, Philadelphia , Associate Director, Medical Monitor, Executive , Collegeville, Pennsylvania
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