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Associate Director, Medical Monitor, Vaccines

Pfizer, S.A. de C.V

Marlow
Hybrid
GBP 60,000 - 80,000
2 days ago
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Chef de Partie

Aramark NV

Greater London
On-site
GBP 40,000 - 60,000
2 days ago
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Entry Level Communication Associate

Themarketsocial

Belfast
On-site
GBP 25,000 - 30,000
2 days ago
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Assistant Civil Engineer

Wilde Consulting Engineers

Manchester
Hybrid
GBP 60,000 - 80,000
2 days ago
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Safeguarding and Wellbeing Officer, Epsom, Surrey

College Group

Epsom
On-site
GBP 22,000 - 25,000
2 days ago
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University Hospitals of North Midlands

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National Grid

England
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2 days ago
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Sunspraysalon

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Norwich
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NHS

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Leeds Safe Roads Partnership

Leeds
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Epsom
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NHS

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ZIGUP plc

Crewe
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GBP 40,000 - 50,000
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Ipsen Group

Wrexham
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Crewe
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Allison Homes Limited

Norwich
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GBP 40,000 - 55,000
2 days ago
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Associate Director, Medical Monitor, Vaccines
Pfizer, S.A. de C.V
Marlow
Hybrid
GBP 60,000 - 80,000
Full time
2 days ago
Be an early applicant

Job summary

A global pharmaceutical company in Marlow is seeking a Clinician Medical Monitor to ensure safety and compliance across clinical trials. Responsibilities include providing medical advice, monitoring safety issues, and participating in regulatory communications. The ideal candidate is a licensed medical professional with experience in clinical trials. This hybrid position offers competitive benefits and aims to foster a flexible work environment for employees.

Benefits

Competitive compensation
Flexible workplace culture
Disability confident employer

Qualifications

  • Licensed to prescribe medicines in a patient care setting for at least one year.
  • Ability to critically evaluate medical/scientific information.
  • Experience with clinical trials preferred.

Responsibilities

  • Provide medical advice during risk assessments.
  • Monitor study safety issues and provide medical context.
  • Participate in Safety Review Team evaluations.
  • Support study team regarding protocol development.

Skills

Medical advice
Safety data review
Clinical trial oversight
Stakeholder communication

Education

Medical degree (M.D./D.O. or equivalent)
Job description

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life‑changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

The clinician medical monitor may contribute towards providing medical and scientific expertise and oversight for Clinical Trials.

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 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.

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:

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 IRB/IECs.

Provides medical input into country feasibility.

Support study team

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 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.

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.

Monitor investigator compliance with protocol and regulatory requirements.

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 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:

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 impact.

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.

Understands the design, development, and execution of clinical programs and studies.

Capacity to adapt to a fast pace and changing environment.

PREFERRED QUALIFICATIONS

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 clinical trials is preferred.

No pharmaceutical industry experience required.

Work Location Assignment

Hybrid

The closing deadline for applications is January 11th.

All applicants must have the relevant authorisation to live and work in the UK.

Purpose

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!

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* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.

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